Tag Archives: FDA

Dr. Bennett identifies what the government should be doing — but isn’t — to guard against unsafe prescription drugs

Dr. Charles Bennett has been an advocate for addressing fluoroquinolone safety concerns for many years. He has has filed multiple petitions with the FDA to get them to change the warning labels for fluoroquinolones–one of the petitions is to get the FDA to add Psychiatric Adverse Events to the Levaquin/levofloxacin warning label, another is to have the FDA add “Possible Mitochondrial Toxicity” to the Levaquin Label, another requesting a black box warning to specifically identify psychiatric adverse events, including suicide and suicide-related adverse events, and likely others. These petitions have led to warning label changes, and have been featured in many of the news stories about fluoroquinolones. Dr. Bennett has also testified before the FDA about fluoroquinolone adverse reactions, and has helped many “floxies” to gain information and support. He is a wonderful advocate, and his advocacy work has increased the credibility of other advocates for fluoroquinolone toxicity awareness. He has changed how many people think of fluoroquinolones, and he has changed how fluoroquinolones are prescribed. He is making a difference.

Dr. Bennett recently wrote a wonderful editorial that was published in the LA Times entitled, “What the government should be doing — but isn’t — to guard against unsafe prescription drugs.” I highly recommend that you read and share it. He has some great ideas and insights, some of which I’m going to highlight in this post (all italicized and indented sections of this post are quotes from the editorial).

He, and his co-authors, state:

The failings are at every point in the system, starting with drug approvals. But we believe there is a particularly serious problem with the mechanisms for identifying, monitoring and disseminating information about issues with a drug after its release.

Once a drug is approved for market, the FDA relies on an informal and ineffective system of case reports and citizens’ petitions to alert it to problems and adverse events. In the past, case reports, submitted to medical journals by physicians, served as an important mechanism for detailing drug toxicity. But today, because of changes to editorial guidelines, peer-reviewed journals rarely accept such reports for publication.

Indeed. Take it from a doctor who specializes in studying adverse drug reactions that the current system of tracking and addressing concerns about adverse drug reactions is failing and ineffective. How many of the thousands (perhaps millions) of adverse reactions to fluoroquinolones have been reported to the FDA through either the adverse event reporting system, a case report, or a citizen’s petition? Unfortunately, not many. It should be noted that, “Many studies have documented that only 10%-15% of serious adverse reactions are reported” to the FDA. Though I encourage every “floxie” to report his or her adverse reaction to the FDA, a voluntary reporting system that is confusing and difficult to navigate, is not a particularly effective way of tracking the actual incidence of adverse drug reactions.

Dr. Bennett also notes that Citizen’s Petitions (many of which he has filed) are not an effective tool for tracking and evaluating post-market adverse drug reactions:

Citizens’ petitions, in which any citizen can petition the FDA to report adverse drug effects, are intended to be another check. But the petition process is cumbersome, and they are rarely granted. Of the 1,915 Citizens Petitions filed in the 12-year period between 2001 and 2013, a total of 13 were granted. Many go unanswered altogether.

The citizen’s petitions filed by Dr. Bennett, Public Citizen, and others, have been helpful advocacy tools, but, as Dr. Bennett and his co-authors point out, they have not been adequate.

Rather than continuing with the ineffective system of depending on patient and doctor reports of adverse reactions, citizen’s petitions, and case-reports to monitor and track adverse drug reactions, Dr. Bennett suggests that a new system for tracking and monitoring drugs with black-box warnings be implemented.

We propose a “black box” database or “registry,” publicly available and simple to use, that would contain extensive information about where, by whom and for what purpose black box drugs are prescribed, as well as where and in what quantities such drugs are being distributed and sold. Information about adverse side effects, culled from the myriad of government databases that now collect them, would also be consolidated in an open form and format.

In addition to the benefits of a black box database/registry noted above, a black box database/registry also has the potential to decrease usage of drugs that have black box warnings:

Is there a chance that the existence of a black box registry would decrease the use of those drugs? Possibly, and that would be a good thing. Too often black box warnings are seen as meaningless, and they are counteracted with marketing campaigns that promote off-label use. If adding more transparency, thought and effort to the prescription and sale of dangerous drugs winds up decreasing their use, that will likely be a beneficial side effect.

It would be WONDERFUL if there were a system in-place that cut down on unnecessary fluoroquinolone prescriptions. It would be WONDERFUL if there were a system in-place that adequately communicated the real risks of fluoroquinolones. I think that Dr. Bennett’s idea of creating a black box registry is an excellent way to do both those things, and it’s absolutely worth a try. The system that we currently have for tracking and addressing adverse drug reactions is woefully inadequate. Change is good – especially if it is in the direction of making people safer.

Thank you Dr. Bennett and co-authors for writing “What the government should be doing — but isn’t — to guard against unsafe prescription drugs.” Your insights and advocacy are greatly appreciated!

*****

FDA Warns About Increased Risk of Aortic Aneurysm and Dissection with Fluoroquinolone Antibiotics

On December 20, 2018, the US FDA released a review that “found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.” (source)

This acknowledgement from the FDA came three years after two major studies showed a statistically significant increase in risk of aortic dissection and aneurysm with fluoroquinolone use. The studies, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” (JAMA Internal Medicine, 2015), and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” (BMJ Open, 2015) both found that fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection, with “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” concluding that:

“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Both “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” are major studies, with “analysis of 1477 case patients and 147 700 matched control cases from Taiwan’s National Health Insurance Research Database (NHIRD) from among 1 million individuals longitudinally observed from January 2000 through December 2011” for the former, and 1.7 million older adults in Ontario, Canada, for the later. They are robust studies that show a statistically significant association between fluoroquinolone-use and aortic aneurysm and dissection.

The FDA took too long to warn the public about the dangers of aortic aneurysm and dissection post exposure to fluoroquinolones, but, better late than never. Here is the full text of the FDA announcement that was published on Thursday December 20, 2018:

[12-20-2018] A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.  People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.  We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.

Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.  Prescribe fluoroquinolones to these patients only when no other treatment options are available.  Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.  Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.  Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.  Before starting an antibiotic prescription, inform your health care professional if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.  If you have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to your health care professional.

We reviewed cases reported to FDA* and four published observational studies1,2,3,4 that showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use (see Data Summary).  How some of the studies were designed or carried out, and the ways the data were analyzed could affect the study findings; however, taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection.  The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population.  The background risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 people per year in individuals at highest risk.  Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.

We communicated safety information associated with fluoroquinolones in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restricting use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving fluoroquinolones or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

More information about the link between fluoroquinolones and aortic aneurysm and dissection can be found in these studies or articles:

  1. JAMA Internal Medicine, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone
  2. BMJ Open, “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study
  3. BMJ, “Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study
  4. Baylor College of Medicine, “Ciprofloxacin increases risk of tears, rupture in mouse aortas

Additionally, here are some news articles about the FDA acknowledgement of the link between fluoroquinolones and aortic aneurysm and dissection:

  1. CNN, “Certain antibiotics may cause aortic aneurysm, FDA warns
  2. NBC News, “FDA warns some antibiotics can cause fatal heart damage: Drugs commonly used to treat upper respiratory infection, urinary tract infections should not be prescribed to patients already at risk
  3. Medscape, “More Fluoroquinolone Safety Concerns
  4. WRIC ABC 8 Richmond, “Commonly prescribed antibiotics can cause potentially deadly ruptures, FDA warns

Fluoroquinolone Prescription Guidelines for Children

The ONLY FDA approved uses for fluoroquinolones in children are:

  1. Anthrax
  2. Plague
  3. Complicated urinary tract infections

That’s it.

All other uses of fluoroquinolones in children are off-label. All pediatric fluoroquinolone prescriptions for treatment of sinus infections, uncomplicated urinary tract infections, respiratory infections, diarrhea, ear infections, etc. are off-label. The FDA has not done a cost-benefit analysis, or a safety analysis, for any use of fluroquinolones in children, other than for treatment of anthrax, plague, and complicated urinary tract infections.

The reason that fluoroquinolones are not approved for most pediatric uses is because, “Fluoroquinolone-induced joint/cartilage toxicity has been observed in juvenile animal studies and is species- and dose-specific with canines exhibiting the highest rate of arthralgias. These early observations led to the contraindication of fluoroquinolones in the pediatric population” (source). Additionally, serious musculoskeletal and nervous system adverse reactions occur at higher rates in children treated with fluoroquinolones than children treated with other antibiotics (source). To put it into simple terms, fluoroquinolones have been shown to cause lameness, stunted growth, joint pain, and other permanent musculoskeletal problems in experiments on juvenile mammals (beagle puppies).

Despite the evidence that fluoroquinolones can cause irreparable musculoskeletal damage to juvenile mammals, there are some people who argue that fluoroquinolone use should be expanded in the pediatric population. Additionally, fluoroquinolones ARE prescribed to children, despite the fact that they cause lameness and arthralgia in animals, and the fact that there are no FDA approved indications for fluoroquinolones other than anthrax, plague, and complicated urinary tract infections.

The Hippocratic Oath and the precautionary principle should be the guiding thought processes when prescribing drugs to children. Drugs that have been shown to cause lameness in juvenile animals, and that have multiple black-box warnings on them, should not be given to children. The current black-box warning for fluoroquinolones states that they can cause “disabling and potentially irreversible serious adverse reactions.” No child should be subjected to even the risk of permanent musculoskeletal problems that could result in disability.

Yet… children are being prescribed fluoroquinolones every day, and they are being put at risk. Because of hubris and the general acceptance of off-label prescribing in medicine, many doctors are subjecting children to the risk of fluoroquinolone toxicity–a constellation of symptoms that includes not only serious musculoskeletal problems, but also autonomic nervous system dysfunction, neuropathy, psychiatric disturbances, blood-sugar irregularities, and more.

It’s not okay. Even the FDA, as ineffective as they are, recognizes that it is not appropriate to subject children to the risk of serious and permanent adverse drug reactions unless they are faced with life-threatening infections like anthrax and plague.

But too many doctors either don’t realize that fluoroquinolone adverse-reactions are severe, or they think that they can gauge the appropriateness of the risk of their prescribing behavior better than the FDA, and they prescribe fluoroquinolones off-label. This is absurd, foolish, and dangerous. Off-label prescribing is essentially experimental. It is not “evidence based medicine,” it is “throw it at the wall and see if it sticks” medicine. And everyone whose child was given a fluoroquinolone for treatment of an infection that wasn’t anthrax, the plague, or a complicated urinary tract infection was, in a sense, experimented on. The approved uses for Levaquin/levofloxacin, Cipro/ciprofloxacin, Avelox/moxifloxacin, and the other fluoroquinolone antibiotics in children are limited, but few doctors are paying attention to what the approved indications for fluoroquinolones are, and I doubt that most physicians even know that fluoroquinolones are not approved for use in children for, say, skin infections, or travelers’ diarrhea, or sinus infections, or swimmer’s ear, etc.

It is awful when anyone is prescribed a dangerous drug in a reckless or uncalled-for way, but it’s particularly horrible when it happens to children. Tragically, children are being hurt by negligent, off-label fluoroquinolone prescriptions. It’s not okay. Yet the FDA, and other world-wide regulators of medicines, are not doing anything to stop this practice. If the FDA is going to pretend to regulate the use of pharmaceutical drugs, they should start with curbing the practice of off-label prescribing – especially for pediatric patients. After all, what good are prescribing guidelines if no one pays attention to them?

Fluoroquinolones are too dangerous for anyone who is not facing a life-threatening infection to use. They are certainly too dangerous for use in children. The FDA knows this, yet they are unwilling to do anything to enforce their own guidelines around pediatric fluoroquinolone prescriptions. Tragically, children are being hurt because of doctors who prescribe fluoroquinolones off-label – and the FDA is unwilling to do anything to stop it.

 

Change Will Come

Ruth wrote this guest post. You can read Ruth’s story of fluoroquinolone toxicity in “Ruth’s Story – Cipro Toxicity.” You can also listen to Ruth’s story through her episode of The Floxie Hope Podcast. THANK YOU, for sharing your insight and wisdom, Ruth! 

There was a long period of time after I got floxed that I despaired of anything ever changing in the medical field. I didn’t think doctors would ever change their prescribing habits regarding fluoroquinolones and people would continue to be harmed as I was, until the end of time, basically. But I recently had an epiphany that brought the realization that not only will the overuse of fluoroquinolones stop, it is inevitable that it does stop.

It is true that America’s FDA is doing a poor job of keeping the public safe from bad drugs and faulty medical devices. But I believe that even if the FDA does not become the watchdog it should be, the needed changes regarding fluoroquinolones will come. Probably not as soon as any of us would like, but they will come.

Every summer I work as a pyro technician for a display fireworks company. I have to undergo training for this. I am kept abreast of the requirements of the ATF, our own industry, and our company. Our own company is stricter than the legal requirements as regards safe distances for spectators. Our own industry has made recommendations to improve safety which are also stricter than what the ATF requires. Sometimes these requirements can seem burdensome or inconvenient.

Why would a fireworks company and professional organizations made up of pyro technicians create their own stricter regulations, when it would be easier to just stick with whatever is legally required? Because sane and rational people want to keep the public safe. Yes, we want to put on a good show, make some money and no one in this world actually wants to have to work harder– but at the end of the day no sane and rational person would want to be responsible for injuring another human being.

I believe the doctors themselves and others working in the medical industry will in the end solve this problem, whether or not the FDA ever wakes up and provides some regulations for use of fluoroquinolones that have some teeth. I believe even the drug companies will reluctantly come around due to social pressure or fear of litigation. I believe this because if it happened in one industry it can happen in another.

New and stricter regulations regarding the transport, handling and use of display fireworks have been met with resistance. I don’t want to paint a picture that says every time a new rule is added everybody is happy about it and immediately gets on board with it. But I have heard the arguments for continuing the old ways and I know why they aren’t holding up, why changes are happening despite opposition. The arguments against changing how fireworks shows are done are the same ones that are used against changing how fluoroquinolones are prescribed. They are all flimsy arguments. Here’s my list:

  1. We’ve always done it this way.
  2. It’s easier to do it this way.
  3. It’s cheaper to do it this way.
  4. I don’t believe this really makes a difference for safety, because I personally have never seen anyone get hurt doing it this way.

Let’s take these one at a time:

We’ve always done it this way” simply does not hold up when the science says what you have been doing is not safe. In both industries those advocating for safety have science on their side. Also, it is mainly the older pyros and older doctors using this argument. As they retire, and young people coming in are trained in a different way, this argument will simply disappear. I have had young pyro technicians come to me and say that an older person on the crew showed them how to do something that was inconsistent with training they received. I confirm that they have to do it the way they were trained and I never get an argument from them.

The more experienced person may continue to argue on the basis of, “I have always done it this way,” but the younger person will distrust anything that goes against the training he or she received. I have heard of some medical schools today teaching about fluoroquinolone toxicity syndrome and cautioning students to avoid using FQ’s unless really necessary. These are second and third hand accounts, but if they are true this is a huge win for us.

Some of the older pyro technicians, sad to say, take themselves out of the picture by choosing to continue doing things that we know today are not safe. Doctors who simply refuse to believe in the dangers of fluoroquinolones and take those drugs themselves also may learn the hard way. I’m not saying people getting hurt should be celebrated, absolutely not, but every time the lesson is learned the hard way it is still learned.

It’s easier to do it this way,” does not fly either in the face of how much people can be harmed. In one case we are talking about explosives that, if they don’t go off in the sky where they are supposed to become actual bombs on the ground, and in the other case we are talking about medications whose side effects have been described many times as being like a bomb going off in the person’s body. The amount of voices speaking out on the horrors of fluoroquinolone toxicity helps our case because after people have read our stories they don’t want to risk FQ toxicity no matter how much the doctor may claim Cipro has a great record of safety and efficacy.

The informed patient is going to request that the doctor culture the infection and prescribe accordingly, rather than just prescribe the broad spectrum antibiotic because it is easier. Patients are refusing to take the atomic bomb of antibiotics when they might not need an antibiotic at all. Being handed Cipro and sent on your way without even knowing for sure you have an infection is not going to continue to be accepted medical care. Those of us who speak out to our friends and post about this here at floxiehope and on social media are part of that change, and we can feel good about that. The dangers are becoming known.

Customers can and do drive changes that improve safety. For a recent fireworks show we were informed that the sponsor had requested we follow recommendations by our own industry for distance between loaded mortars. They were actually asking that we follow California’s standards, even though the show was shot in Wisconsin. What reason could we give for not doing what the customer asked? It’s easier to be able to load all the mortars right next to each other in the old style racks than to skip tubes or use the newer ones that have the required spacing? That would have been our only reason to refuse that request: It’s easier to do it the old way.

But the sponsor was making the request because he wanted as safe a show as possible. When patients make requests of their doctors because they want to be as safe as possible the doctor cannot really make any argument that is going to hold up as to why he should not honor those requests. Today we are seeing customers of display fireworks companies taking the time to inform themselves about our industry and what we do! How much more so are patients today taking the time to become informed? In both cases it is happening because the Internet makes information about any subject easily available. When we speak out about our reactions to fluoroquinolones we are helping provide valuable information for others.

It’s cheaper to do it this way,” may seem to be a logical reason to resist changes. After all, companies need to watch their bottom line. But when it comes to a question of money or public safety, the need for public safety will eventually win. There may be a period of time during which companies can make some money while risking the health and safety of other human beings, but eventually that time will end.

People have a desire for self preservation. Whether it is pyro technicians experiencing danger from low breaks, round trippers and finale racks blowing up or patients experiencing or reading about bad ADR’s to a drug, people are going to run the other way when their life or health could be put in danger. Fireworks companies that buy cheap but unreliable product lose workers and have difficulty selling more shows without crews to put them up. Hospitals that use fluoroquinolones for every little thing lose informed patients. If I needed surgery I know where I would go for it, because I know of hospitals (a couple) that do not use fluoroquinolones. If I had to pay out of my own pocket I would do it, because my health and safety is that important to me.

I know of display fireworks companies that are now out of business after consistently focusing on the bottom line instead of safety. I believe the same will hold true for medical facilities, doctors and even drug companies that continue to put money ahead of human health and safety. The display fireworks company I now work for tests all their product and they spend extra money to get product that is going to perform as it is supposed to. They are rewarded for this not only with greater customer satisfaction for some really beautiful shows, but they attract more workers. Pyro technicians would rather work where they feel safe and know they are not putting members of the public at unnecessary risk.

I think the same holds true in health care. I used to work for a medical staffing company in physical therapy. Some companies I temped for definitely cared only about the bottom line, with very high productivity standards. I was so rushed that I knew I was not really able to provide good care, and that put patients and myself at risk. I stopped taking jobs for those companies. Companies that had compassion for both their patients and employees attracted the best workers and could even pick and choose, selecting the cream of the crop of therapists, doctors and nurses. Patient satisfaction went up. While some of the companies that had pushed so hard for productivity were being bought out, the companies that I most preferred to work for were thriving. Decisions made with concern only for the bottom line always come back to bite the companies making them right in the butt.

I don’t believe this really makes a difference for safety, because I personally have never seen anyone get hurt doing it this way,” was the excuse my own doctor used for prescribing Cipro to me for a sinus infection. She had personally never seen anyone have a reaction to Cipro. Well, that is anecdotal evidence and it’s weak. The medical community cannot on one hand say that mountains of anecdotal evidence that fluoroquinolones are harming people is not strong enough evidence and then use anecdotal evidence themselves for their continued widespread use. The changes the FDA recommended for the use of fluoroquinolones in 2016 were made for a reason. A panel of experts heard the testimony of those harmed and looked at medical research regarding fluoroqouinolones and made an informed decision. Making a decision based only on your own experience and observations is not an informed decision.

I say that change will happen in the medical field because in the pyrotechnic industry change is happening. When a change is recommended in how something is done it is probably because somebody got killed doing it the old way. People who want to be safe believe those recommendations even if they personally never witnessed an accident. The same will happen with doctors. Even if they never personally had a patient get floxed, they will follow FDA prescribing guidelines for FQ’s because they do not want to harm other human beings.

One thing that does stand in the way of this change is cognitive dissonance created by the very fact that no sane and rational person wants to harm another human being. As the evidence comes out that fluoroquinolones are insanely dangerous and that the side effects are horrific, long lasting and sometimes permanent, doctors do not want to believe that they put anyone through that. The fact that reactions are delayed means they most certainly could have severely harmed a patient and never known about it because the connection to the antibiotic was never made. It is going to be very hard for doctors to come to terms with this, and I think it is behind a lot of their strident claims that Cipro is “safe and effective.” They need it to be, because if it were not, then there is a good chance they have harmed those they meant to help.

A floxed friend recently shared her experience with an ER doc who tried to give her Cipro for a UTI without even culturing to confirm an infection. She gave him an earful and the expression on his face said that she got through to him. He was horrified. He will either now disbelieve her because he must to avoid a truth he cannot face (that he may have harmed patients) or he will do some research, find the truth, change his prescribing habits and speak to his colleagues. I believe that in time even this cognitive dissonance will be overcome and doctors will do what is right, follow the recommendations of the FDA, and stop prescribing fluoroquinolones in situations that do not warrant their use.

The fluoroquinolone catastrophe has gone on far too long. It can be discouraging to reflect on how many have been needlessly harmed. However, as I have observed changes happening in the pyrotechnic industry that, although sometimes opposed, do happen and do increase public safety, I have to believe that the medical industry is not immune to those same types of changes. I think if it were easier to sue for harm done by pharmaceuticals, that would actually be a good thing, because sadly, there are some people out there who are neither sane nor rational, but consumed with greed. Only one thing gets their attention, and that is losing money. There has to be more accountability for drug companies and doctors who prescribe dangerous drugs needlessly. I do believe it will happen and in the meantime, as we inform people about the dangers of fluoroquinolones we are playing our part in bringing about these much needed changes to the medical industry.

Levaquin Production Stopped by J&J/Janssen Pharmaceuticals

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

We did this. All the people who filed complaints with the FDA, who testified before the FDA, EMA, and other regulatory agencies, who reached out to the press and told their stories, who shared their story of pain and suffering brought on by fluoroquinolones, all the people who shared articles about fluoroquinolone toxicity, all the scientists who did research showing the harm done by fluoroquinolones, all the advocates, all the people in the floxie community, and all the people who listened–we did this! We screamed loudly enough that people listened. Our efforts made a difference, and Janssen Pharmaceuticals has stopped making Levaquin.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Janssen decided to stop making Levaquin because, a) their market share was small because generic levofloxacin is cheaper and widely available (“’Levaquin was only about 1 percent of the market share, and 99 percent was the generic,’ said Bennett.”), and b) they were facing significant lawsuits, and to avoid liability for the drugs they created, they pulled them from the market.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

Because victims of pharmaceuticals can only sue for “failure to warn” the door for them to sue is only open when the drug warning labels change. Fluoroquinolone warning labels have undergone significant changes in recent years. In reverse-chronological order, the following warning label changes have been added to fluoroquinolone labels:

  • In July, 2018, fluoroquinolone warning labels were changed to note that, “Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects” – Drug Safety Communication
  • In July, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together” – Drug Safety Communication
  • In May, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” – Drug Safety Communication
  • In August, 2013, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” – Drug Safety Communication
  • In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We pushed the FDA to change their warning labels. They did, and we should be proud of that. The warning label changes scared Janssen and J&J enough that they stopped production of Levaquin, and we should be proud of that too.

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Fluoroquinolone Warning Labels Updated to Include Low Blood Sugar Levels and Mental Health Side Effects

On 7/10/18 the FDA announced that fluoroquinolone (Ciprofloxacin, Levofloxacin, Moxifloxacin, Ofloxacin, and a few others) warning labels are to be updated to include adverse effects on blood-sugar levels, as well as serious mental health effects:

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

This is a HUGE development! To have the FDA acknowledge that fluoroquinolones cause both hypoglycemia (low blood sugar), and that the effects of hypoglycemia include:

  • confusion
  • pounding heart or very fast pulse
  • dizziness
  • pale skin
  • feeling shaky
  • sweating
  • unusual hunger
  • trembling
  • headaches
  • weakness
  • irritability, and
  • unusual anxiety

is a massive move in the right direction for patients and advocates alike.

Additionally, in the same announcement, the FDA noted that the following mental adverse effects can occur with fluoroquinolone use:

  • disturbances in attention
  • disorientation
  • agitation
  • nervousness
  • memory impairment
  • serious disturbances in mental abilities called delirium.

Fluoroquinolone toxicity victims have long known that fluoroquinolones cause both blood sugar disturbances and serious mental health adverse-effects.

Information about the effects of fluoroquinolones on blood-sugar can be found in these posts/articles:

Information about the mental health adverse-effects of fluoroquinolones can be found in these posts/articles:

Additionally, the book, Bitter Pills: Inside the Hazardous World of Legal Drugs by Stephen Fried goes over his wife Diane’s severe psychiatric adverse reaction to a fluoroquinolone (Floxin/ofloxacin).

WE know about the blood sugar and psychiatric effects of fluoroquinolones. The FDA does too. Now they have acknowledged that they know about these horrible, life-altering, sometimes life-threatening effects of fluoroquinolones.

This acknowledgement from the FDA is a big step in the direction of getting fluoroquinolone toxicity more widely acknowledged. However, whenever there are updates to the warning labels, there are many people who say, “so what? It’s just a warning label that no one pays attention to. When is the FDA going to really DO SOMETHING to fix this problem – like find a cure for fluoroquinolone toxicity and/or remove FQs from the market?” Those people have plenty of good points, and I went into some depth in addressing them in the post, “Change the Warning Labels: Why it Matters.” In that post, I assert that one of the things that changes to warning labels does is open the door for people to sue the drug-makers:

“Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies.”

Everyone who has suffered from hypoglycemia or mental health issues post-fluoroquinolone exposure now has a window open to file a lawsuit against the pharmaceutical companies that made the drugs that hurt them. Here are some law firms that have taken fluoroquinolone-harm cases in the past:

There are others too (feel free to let me know if you know of firms that are taking these cases). I hope that Bayer, Johnson & Johnson/Jansen Pharmaceuticals, and all the generic producers of fluoroquinolones pay for the harm that their products are doing to people, and I encourage all victims to seek justice through the legal system.

I hope that this warning label change will help fluoroquinolone toxicity victims to gain acknowledgement and justice. Everyone who has been hurt by these drugs deserves both.

 

 

Fluoroquinolones Increase Risk of Aortic Aneurysm

Evidence is mounting that fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, and their generic equivalents) increase the risk of aortic aneurysm and dissection, yet the FDA is denying the connection between fluoroquinolone use and the potentially deadly vascular conditions.

In a May, 2017 notice on fda.gov, the FDA stated:

“As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.”

This statement was made after two major studies were released, showing the statistically significant increase in risk of aortic dissection and aneurysm with fluoroquinolone use. “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” (JAMA Internal Medicine, 2015), and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” (BMJ Open, 2015) both found that fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection, with “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” concluding that:

“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Both “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” are major studies, with “analysis of 1477 case patients and 147 700 matched control cases from Taiwan’s National Health Insurance Research Database (NHIRD) from among 1 million individuals longitudinally observed from January 2000 through December 2011” for the former, and 1.7 million older adults in Ontario, Canada, for the later. They are robust studies that show a statistically significant association between fluoroquinolone-use and aortic aneurysm and dissection.

Still, the FDA doesn’t acknowledge that there is a connection between fluoroquinolone-use and these potentially deadly disorders.

Before you defend the FDA by saying something like, “correlation doesn’t mean causation,” or, “an association doesn’t prove anything,” think about what it would take to do a study that would actually show a causal link between fluoroquinolones and aortic dissection and aneurysm–researchers would have to intentionally expose a group of people who they knew were at-risk for aortic dissection and/or aneurysm to Cipro, and another group of people who presumably had an infection to a placebo, then see whether or not they were hurt or died from the exposure. You can’t do this experiment on humans for fairly obvious reasons.

However, you can do the experiment with mice, and a team of researchers from Baylor College of Medicine, the Texas Heart Institute, and Baylor College of Medicine’s Cardiovascular Research Institute, “found that ciprofloxacin, a widely prescribed antibiotic, increases the risk of tears and rupture on the main artery of the body, the aorta, in a mouse model of human aortic aneurysms and dissections (AAD), a disease that carries high risk of death from aortic rupture.” (source) The study showed that:

“normal, unstressed mice treated with ciprofloxacin did not show significant negative effects on the aorta. In mice with moderately stressed aortas that had received the placebo, 45 percent developed AAD, 24 percent developed aortic dissection and none had rupture. On the other hand, 79 percent of the mice with moderately stressed aortas that received antibiotic developed AAD, 67 percent had aortic dissection, and 15 percent had fatal rupture. These results were similar in males and females.” (source)

Though mice with normal aortas weren’t negatively affected by the Cipro exposure, those with stressed aortas were harmed–some fatally. These results, combined with the human population-based longitudinal cohort studies noted above, show, as strongly as we can without subjecting humans to unethical experiments, that fluoroquinoloes (or at least Cipro), increase the risk of aortic aneurysm and dissection in those with previously stressed aortas.

To further their case that fluoroquinolone-use led to aortic aneurysm and dissection, the Baylor researchers also explored the mechanism(s) through which Cipro/ciprofloxacin damages the extracellular matrix, and contributes to the weakening of aortic tissues:

“The researchers then looked deeper into the effects of ciprofloxacin on mouse aortas searching for insights into the antibiotic’s mechanism of action. Compared with the aortas from stressed mice treated with the placebo, the aortic tissue of stressed mice treated with the antibiotic showed more destruction and fragmentation of elastic fibers; decreased activity of LOX, a key enzyme involved in stabilizing the extracellular matrix; increased activity of MMP enzymes involved in extracellular matrix degradation; and enhanced activation of cellular pathways that lead to cell death. Separate laboratory experiments on human aortic smooth muscle cells revealed that sustained ciprofloxacin exposure reduced the expression of LOX while enhancing the expression of MMP and inducing cell death. In these experimental settings, the antibiotic is disrupting the natural processes that maintain the integrity of the extracellular matrix that is essential for normal aortic function.” (source)

Links to studies that show that fluoroquinolones increase expression of damaging MMP enzymes, as well as oxidative stress, can be found in the posts, “Fluoroquinolones Increase Expression of MMPs” and “Antioxidant Depletion by Fluoroquinolones.

The evidence that fluoroquinolones increase the chance of aortic aneurysm and dissection in succeptible individuals is significant. The large population-based studies are compelling, the mouse study establishes a stronger causal link, and many studies that show the damaging effects of fluoroquinolones on cell, collagen, and extracellular matrix, health, each add weight to the argument that fluoroquinolones are contributing to potentially deadly aortic aneurysm and dissections. Yet, the FDA is still claiming that studies don’t support a connection. I’m not sure what else they need in order to convince them that aortic aneurysm and dissection are, indeed, linked to fluoroquinolones. The evidence seems strong and compelling to me, and I suspect that they are just wrong.

Additionally supporting the link between fluoroquinolones and aortic aneurysm and dissection are personal testimonials of connections and damage done. In comments on the post, “Hurt by a Generic Drug? Victims have no Recourse unless the FDA Changes Rules,” published on hormonesmatter.com, one person noted that:

“I took a generic levaquin, a week or so later I had an aortic dissection. It was descending so it was not fixed by surgery. I now have an aortic aneurysm. The tear is pasted together with blood clots. A CT scan every 6 mos to check the size of the aneurysm. Keep my bp below 120.”

Another responded that:

“Took generic Leviquin 7 weeks later aortic dissection. Tore 2 layers of muscle from over my aortic valve down thru and ended in my thighs. Doctor said I would not survive operation. Tear was so big over the valve had to put in synthetic patch.”

In testimony to the FDA, Sherry Reiver stated:

“Four years ago today, my 93 year old dad died. He FELL at home and was taken to the hospital by a neighbor. By the time my husband and I arrived in Florida, my dad had no idea who we were. They THOUGHT he had pneumonia so they IV’d him with Levaquin. It turned out that he did NOT have pneumonia but he continued to hallucinate for 6 weeks and then died. He was sharp as a tack before Levaquin dripped into his body. He did have an aortic aneurysm for many years which was being watched but it ruptured on November 4th. I would have never connected the AA with FQs until I read this research paper dated October 5th 2015. So here is another RARE side effect that can occur, which it did in my dad’s case. How many others have died from AAs and had taken a FQ drug?”

There is significant evidence that fluoroquinolones contributed to these aortic aneurysms and dissections, as well as those of thousands of other patients. These patients weren’t warned that fluoroquinolones could increase their chances of aortic aneurysm or dissection, and they haven’t had the opportunity to gain retribution or justice, in part because the FDA has failed to acknowledge the connection between fluoroquinolones and aortic aneurysm and dissection.

With the publishing of the Baylor mouse study, I hope that the FDA will acknowledge the connection between fluoroquinolone use and aortic aneurysm and dissection. I also hope that acknowledgement from the FDA will lead to justice for victims, and pain for the pharmaceutical company perpetrators who produce and market these dangerous drugs.

Also, all of the studies that connect fluoroquinolones to aortic aneurysm and dissection are greatly appreciated, and I want to thank all of the researchers and scientists who conducted the studies, as well as those who fund them. Research into adverse drug reactions, and patient safety, are important. All of the researchers and scientists who look into adverse drug reactions, especially fluoroquinolone reactions, are appreciated, and I thank them sincerely.

 

 

 

 

Fluoroquinolone Warning Labels to be Updated in Canada

Health Canada, the department of the government of Canada with responsibility for national public health (like the U.S. Food and Drug Administration) has “carried out a review of the potential risk of persistent and disabling side effects linked to the use of fluoroquinolones. The review was triggered by a benefit and safety review done by the United States Food and Drug Administration (FDA) on systemic (taken by mouth or by injection) fluoroquinolone drugs.”

The Canadian Review of fluoroquinolones concluded that (SOURCE):

  • Health Canada’s review concluded that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders, already linked to the use of fluoroquinolones, may be persistent and/or disabling. Given the high use of fluoroquinolones in Canada and the information reviewed, these side effects are considered rare.
  • Health Canada recommended that the safety information for all fluoroquinolone products be updated to include information about this rare but serious risk. Health Canada is working with manufacturers to update the safety information of all systemic (taken by mouth or by injection) fluoroquinolone products marketed in Canada. In addition, an Information Update and a Health Care Professional Letter will be published and distributed to further inform Canadians and healthcare professionals about this risk.
  • Health Canada is working with the Drug Safety and Effectiveness Network (DSEN) and the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct additional studies to better understand the use of fluoroquinolones in Canada.
  • On October 6, 2016, Health Canada brought together a Scientific Advisory Panel on Anti-Infective Therapies to discuss the risks associated with the use of fluoroquinolones. The panel recommended that the safety information for fluoroquinolones be updated, and risk communications be published and distributed to further inform Canadians and healthcare professionals about the potential risk that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders may be persistent and/or disabling.
  • Health Canada will continue to monitor safety information involving fluoroquinolones, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

As a result of its safety review, Health Canada is working on updating fluoroquinolone warning labels.

Additionally, above and beyond what the U.S. F.D.A. has done, Health Canada has agreed to publish and distribute a Healthcare Professional Letter regarding fluoroquinolone risks. The Healthcare Professional Letter includes the following points:

  • It is recommended that the potential for disabling and persistent serious adverse events be considered when choosing to prescribe a fluoroquinolone.
  • Fluoroquinolones should not be prescribed to patients who have experienced serious adverse reactions during or after prior treatments.
  • Healthcare professionals are advised to stop systemic fluoroquinolone treatment if a patient reports a serious adverse reaction. The patient’s treatment should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug if needed to complete the treatment course.
  • Healthcare professionals should be aware that some adverse reactions associated with the use of fluoroquinolones can occur within hours to weeks after exposure to the treatment.

This acknowledgement from Health Canada that fluoroquinolones may have permanent and/or disabling effects is a huge step in the right direction for Canadian “floxies.”

All Canadians who have experienced adverse reactions to fluoroquinolones are encouraged to report their reactions to Health Canada through the Canada Vigilance Adverse Reaction Online Database.

This acknowledgement from Health Canada is a huge step in the direction of safety and informed consent for all Canadians. It is appreciated!

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Consumer Reports Warns Patients About Fluoroquinolone Dangers

consumer-reports-0816

Consumer Reports has published several articles about the dangers of fluoroquinolone antibiotics (including Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others). Their help in getting the word out to their readers about the risks associated with fluoroquinolone antibiotics is greatly appreciated!

The picture above, from the August, 2016 print issue of Consumer Reports, states:

These potent antibiotics are often prescribed to treat bronchitis, sinus infections, and urinary tract infections. But drugs such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and ofloxacin (Floxin) can cause irregular heartbeats, depression, nerve damage, ruptured tendons, seizures, and other serious side effects. The Food and Drug Administration issued an alert in May saying that fluoroquinolones should not be used to treat bronchitis, sinus infections, and UTIs, unless other options have not worked.

Avoid Problems. If your doctor suggests a fluoroquinolone, ask why. For sinus infections, you might need an antibiotic if your symptoms last more than a week or if you have a high fever, but the first option should be amoxicillin. For a UTI, fluoroquinolones are only necessary if the infection is resistant to other antibiotics or has spread to your kidneys. And they are necessary for chronic bronchitis only if you require hospitalization.

In Fluoroquinolones Are Too Risky for Common Infections: The FDA advises restricting use of popular antibiotics such as Cipro due to dangerous side effects, Consumer Reports notes that the FDA “is advising against prescribing fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, to treat three common illnesses —bronchitis, sinus infections, and urinary tract infections.” The article also quotes Rachel Brummert, the Executive Director of the Quinolone Vigilance Foundation, and notes that her injuries from Levaquin include tendon ruptures and progressive nerve damage. The article also gives a guide of when to say no to fluoroquinolones. It’s an excellent article–please share it far and wide.

In Make Sure Your Doctor Prescribes the Right Antibiotic: There are safer, better options than fluoroquinolones and other frequently prescribed broad-spectrum drugs, the severe effects of fluoroquinolones are noted:

“For example, fluoroquinolone antibiotics such as ciprofloxacin (Cipro and generic) and levofloxacin (Levaquin and generic)—which are frequently prescribed inappropriately for sinus infections in adults—can cause permanent and debilitating damage to muscles, tendons, and nerves.”

As the title of the article says, there are safer, better options than fluoroquinolones (in many situations).

In Surprising Remedy for Deadly Hospital Infections: New study suggests doctors cut back on antibiotics. Here’s what you need to know. it is noted that fluoroquinolone use can lead to c. diff infections:

“Research published in The Lancet, a British medical journal, shows that when doctors in U.K. hospitals cut back on prescribing Cipro, Levaquin, and other so-called fluoroquinolone antibiotics, the rate of deadly infections from the bacteria known as C. diff dropped a whopping 80 percent.”

Fluoroquinolones wipe out the good bacteria that keep c. diff bacteria suppressed. When those good bacteria are eliminated, c. diff infections can take over. C. diff infections can be deadly, and all healthcare professionals should take note of this (somewhat counterintuitive) study.

All of the articles linked to above also note that fluoroquinolone over-use is contributing to antibiotic resistance.

In Meds That Cause Blurred Vision, Hearing Loss, and More: Painkillers, antibiotics, and other common drugs can trigger surprising side effects Cipro is listed as a drug that can cause double vision.

In I Didn’t Know That Antibiotics Shouldn’t Always be Used to Treat Bronchitis, Mary H. describes how Levaquin (prescribed to treat bronchitis) led to Stevens-Johnson Syndrome, which can be deadly.

All of these Consumer Reports articles are greatly appreciated, and I encourage you to read them, comment on them (where possible), and share them with your loved ones.

Consumer Reports has been a trusted source of information, and a strong advocate for consumer protection, since its founding in 1936. The articles linked-to above are from a highly respected source that is trusted by millions of people. It is a credible publication.

For a trusted and credible publication like Consumer Reports to be publishing information about the severe and varied health maladies that are associated with flouroquinolones is a huge step in the right direction. Their acknowledgement of the FDA’s updated warnings on fluoroquinolones, as well as the testimony of patients who have been hurt by fluoroquinolones, is appreciated immensely.

Thank you, Consumer Reports! Please keep it up, and hopefully other trusted news and consumer advocacy publications will follow suit.

 

 

New Fluoroquinolones in the Pipeline

The most commonly prescribed fluoroquinolones are Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin. Almost every “floxie” that has been poisoned by fluoroquinolones in the last 15 years has taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin. However, there are many other quinolones and fluoroquinolones that have been developed. Here is a list:

First-generation:

Second-generation:

  • ciprofloxacin (Cipro) -Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • enoxacin (Enroxil, Penetrex) – withdrawn from the market
  • fleroxacin (Megalone, Roquinol) – withdrawn from the market
  • lomefloxacin (Maxaquin)  – withdrawn from the market
  • nadifloxacin (Acuatim, Nadoxin, Nadixa)  – withdrawn from the market
  • norfloxacin (Lexinor, Noroxin, Quinabic, Janacin)  – withdrawn from the market
  • ofloxacin (Floxin, Oxaldin, Tarivid) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pefloxacin (Peflacine) – withdrawn from the market
  • rufloxacin (Uroflox) – withdrawn from the market

Third-generation:

  • balofloxacin (Baloxin) – withdrawn from the market
  • grepafloxacin (Raxar) – withdrawn from the market
  • levofloxacin (Leflox, Cravit, Levaquin, Tavanic) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pazufloxacin (Pasil, Pazucross) – withdrawn from the market
  • sparfloxacin (Zagam) – withdrawn from the market
  • temafloxacin (Omniflox) – withdrawn from the market
  • tosufloxacin (Ozex, Tosacin) – withdrawn from the market

Fourth-generation:

  • clinafloxacin – Not withdrawn from market, but not commonly available
  • gatifloxacin (Zigat, Tequin) – Tequin removed from the U.S. market, but other forms remain available.
  • gemifloxacin (Factive) – Currently available. More commonly prescribed outside of the U.S.
  • moxifloxacin (Acflox Woodward, Avelox,Vigamox) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • sitafloxacin (Gracevit) – withdrawn from the market
  • trovafloxacin (Trovan) – withdrawn from the market
  • prulifloxacin (Quisnon) – withdrawn from the market

Despite the fact that 22 of the 29 quinolones listed above have been removed from the market, and the fact that there is an updated black box warning label (the most serious warning possible on a pharmaceutical), that notes that the fluoroquinolones remaining on the market can cause permanent disability, several pharmaceutical companies are busily developing new fluoroquinolones.

Some of the fluoroquinolones in development include:

  • Delafloxacin (Baxdela) – Delafloxacin/Baxdela is being developed by Melinta Therapeutics, and is currently undergoing Phase III trials. It is supposed to be more effective at treating MRSA and other bacterial infections that are currently resistant to other fluoroquinolones. Melinta says that delafloxacin/Baxdela has a “favorable safety profile,” but, frankly, I don’t believe them. Bayer says that Cipro has an excellent safety profile, but thousands of people have been injured, disabled, and killed by it. Delafloxacin/Baxdela will be effective against gram-positive, gram-negative, atypical and anaerobic bacteria–meaning that it will be a broad-spectrum antibiotic that will kill all microorganisms in its path. I understand that MRSA is a serious, and potentially deadly infection, and that it may be appropriate to use an extra-powerful fluoroquinolone in cases of life-or-death. However, as an extra-strong fluoroquinolone, with an increased scope of bacteria that it kills, it will be a dangerous, and deadly for some, drug. I hope that delafloxacin/Baxdela will be reserved for treating life-threatening MRSA infections, and that it will not be prescribed for treatment of simpler or less dangerous infections.
  • JNJ-2Q – JNJ-2Q is being developed by Furiex Pharmaceuticals, who have licensed JNJ-Q2 from Janssen Pharmaceuticals, a unit of Johnson & Johnson. Like delafloxacin/Baxdela, JNJ-2Q is being developed for the treatment of MRSA, and it is also a particularly strong and potent fluoroquinolone. Again, I hope that it is only used for deadly MRSA infections.
  • Nemonoxacin (Taigexyn) – Nemonoxacin/Taigexyn, developed by TaiGen Biotechnology Company, is currently undergoing phase III trials in the U.S. However, it has already reached the market in Taiwan, Russia, Commonwealth Independent States, Turkey, mainland China, and Latin America. It is also more effective against MRSA than the fluoroquinolones that are currently on the market, and it is more potent than ciprofloxacin, levofloxacin, and moxifloxacin. Not-so-fun-fact – Nemonoxacin has been fast-tracked for approval by the FDA.
  • Zabofloxacin – Zabofloxacin was discovered by Dong Wha Pharmaceuticals and licensed to Pacific Beach BioSciences for development. It is currently undergoing clinical trials. “The spectrum of activity of zabofloxacin includes bacterial strains that are responsible for most community-acquired respiratory infections. Phase III clinical studies are currently ongoing at Dong-Wha for the treatment of patients with acute bacterial exacerbation of chronic obstructive pulmonary disease.” (source)

Be aware that these new fluoroquinolones are in the pipeline. Know their names so that you can avoid them.

I’m not sure how anyone else’s medical record works, but when I asked my doctor to put that I am allergic to fluoroquinolones on my medical record, her computer system wouldn’t allow her to do so. Instead, I had to list all of the fluoroquinolones that I wanted to avoid individually. I suggest that you tell your doctors not only that you can’t have fluoroquinolones, but that you can’t have Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin specifically. And, when they reach the market, I suggest that you add Baxdela/delafloxacin, JNN-2Q, Taigexyn/nemonoxacin, and zabofloxacin to your list of drugs that you cannot tolerate.

I find the dissonance between the people who review drug safety, and the people that approve new drugs, both of whom are within the FDA, to be a bit mind-boggling. How could the Antimicrobial Drugs Advisory Committee decide that the current warnings on fluoroquinolones are inadequate and that they shouldn’t be prescribed for sinus infections, colitis or UTIs, or chronic bronchitis because they are too dangerous, while another part of the FDA fast-tracks the approval of Taigexyn/nemonoxacin, an even more powerful fluoroquinolone antibiotic? Do they not speak to each other? I can’t fathom that there is not at least some overlap between the Antimicrobial Drugs Advisory Committee and the people who approve new antimicrobial drugs. Are there people at the FDA who are screaming about these new fluoroquinolones that are about to enter the market, and noting that they are horribly unsafe? Or, did the Antimicrobial Drugs Advisory Committee just update the warning labels on existing fluoroquinolones to shut up patient advocates (you and me)? Is there massive cognitive dissonance at the FDA? Because it certainly appears that there is. The people at the FDA, and the Antimicrobial Drugs Advisory Committee specifically, pretend to acknowledge the dangers of fluoroquinolones, and pretend to do something about those dangers, while still thinking that it’s appropriate to approve new, stronger fluoroquinolones for public use. It’s mind-boggling.

There is constant repetition of some mantra along the lines of “fluoroquinolones have an excellent record of safety and efficacy” among drug-makers, drug-regulators, and drug prescribers – despite a massive amount of evidence to the contrary. The list of quinolones/fluoroquinolones above clearly shows that 22 of the 29 drugs have been removed from the market–many because of serious safety concerns. Yet, new, more powerful, fluoroquinolones are entering the market, in part because, for some odd reason, Cipro and Levaquin are seen as “safe.” They’re not safe though. They cause permanent disability and death. The upcoming fluoroquinolones will be worse.

I hope that the new fluoroquinolones that are coming to market are only used to treat life-threatening MRSA infections, but I have no faith that that will be the case. These new fluoroquinolones will be marketed as being bigger/better/faster/more powerful than safer alternatives, doctors will prescribe them, and patients will suffer because of them. Hopefully I’m being too pessimistic, and some prudence will be shown in the prescribing of these dangerous drugs–I doubt that though.

Just be aware of the dangers of fluoroquinolones–both old and new, and protect yourself and your loved ones. Share information about the dangers of fluoroquinolones with your friends and family, and let them know that fluoroquinolones should never be used unless there are no viable alternatives, and the infection is life-threatening. These new fluoroquinolones are more powerful, and more dangerous, than the fluoroquinolones that are currently on the market, and the ones that are on the market are pretty horrible. They should all be avoided like the plague.

 

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Publicizing Fluoroquinolone Warnings

I have such mixed feelings about the FDA’s response to the November, 2015 Antimicrobial Drugs Advisory Committee meeting regarding fluoroquinolone safety. On one hand, I feel like they really did hear those who testified, and they not only listened, they responded in a way that showed that they listened. The FDA did what the Antimicrobial Drugs Advisory Committee recommended they do: they updated fluoroquinolone warnings to note that, “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.” They not only updated the warning labels, they updated the black-box warnings–the most severe warning a drug can have. I am truly grateful for the steps forward in acknowledging fluoroquinolone adverse-reactions, and I’m hopeful that the updated warning labels will lead physicians and patients to realize that fluoroquinolones are dangerous drugs with potentially devastating consequences.

I wonder though, what good is an updated warning label? In the post, Who Reads the Drug Warning Labels? I go over the problem of people not knowing what is on the warning labels. Are physicians going to read the updated warning labels? Are patients? Is anyone other than the “floxie” community going to realize that the warning labels have been changed?

I appreciate the action taken by the FDA–I really do–but are updated warning labels actually going to change anything? Will fewer people get injured and killed by fluoroquinolones? I certainly hope that a significant portion of doctors hear about the warning label changes, and stop prescribing fluoroquinolones, but, unfortunately, the FDA isn’t taking any major steps to make this happen.

The FDA has no plans to inform individual doctors about the recent warning label changes made to fluoroquinolone warning labels. Even though the black-box warnings, again–the most severe warning label a drug can receive, have been updated to note that fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, the FDA is not going to tell doctors about the changes. No “dear doctor” letter will be issued by the FDA. They will not do a massive publicity campaign to let physicians or patients know that the warning labels have been updated. They know about the dangers of fluoroquinolones, and, in their own way, they acknowledge them, but they’re not proactively communicating what they know to patients or physicians.

Since the FDA isn’t going to issue a “dear doctor” letter, it will likely be helpful if we (the people in the fluoroquinolone toxicity community, and those who care about drug safety) give the information the FDA has released to our doctors, local hospitals, and media.

I encourage everyone reading this to please, please, please send this information (that is directly from the FDA) to your doctors, the media, your friends, your loved ones, and anyone else who you think may benefit from the information. People need to know how dangerous Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Factive/gemifloxacin are. In order for them to know how dangerous these drugs are, we need to tell them.

Please forward these FDA releases to those who need this information:

  1. 5/12/16 – Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
  2. 7/26/16 – FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
  3. July, 2016 Drug Safety Labeling Changes

Since most people don’t actually click on links, I’m also going to copy and paste what the FDA notices said (feel free to share this post with anyone who needs the information too).

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections:

AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient

ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.

BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects:

SAFETY ANNOUNCEMENT

The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

ADDITIONAL INFORMATION FOR PATIENTS

  • Fluoroquinolone antibiotic medicines are associated with disabling and potentially permanent serious side effects that can occur together in the same patient and should not be used to treat certain uncomplicated infections. These uncomplicated infections include acute bacterial sinusitis (ABS), acute worsening of bacterial chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI).
  • These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, and can occur within hours to weeks after starting a fluoroquinolone medicine.
  • FDA has updated the Boxed Warning in the labels, added new warnings, and has revised the patient Medication Guide of all fluoroquinolone antibiotics.
  • Contact your health care professional immediately if you experience any serious side effects while you are taking your fluoroquinolone medicine.
  • Before starting a new fluoroquinolone medicine, inform your health care professional if you have previously experienced any serious side effects with another antibiotic.
  • Serious side effects involving the tendons, muscles, joints and nerves include:
    • Swelling or inflammation of the tendons
    • Tendon rupture
    • Tingling or pricking sensation (“pins and needles”)
    • Numbness in arms or legs
    • Muscle pain
    • Joint pain
    • Joint swelling
  • Serious central nervous system side effects include:
    • Depression
    • Hallucinations
    • Suicidal thoughts
    • Confusion
    • Anxiety
  • Other side effects include:
    • Abnormally rapid or irregular heart beat
    • Ringing or buzzing in the ears
    • Vision problems
    • Skin rash
    • Sensitivity of skin to sunlight
    • Headache
    • Trouble falling asleep
    • Fatigue
  • Read the patient Medication Guide you receive with your fluoroquinolone antibiotic prescriptions, which explains the benefits and risks of the medicine.
  • Talk to your health care professional if you have questions or concerns about fluoroquinolone antibiotic medicines.
  • We communicated safety information associated with fluoroquinolones in May 2016, August 2013, andJuly 2008.
  • Report side effects from a fluoroquinolone or any drug to your health care professional and the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

ADDITIONAL INFORMATION FOR HEALTH CARE PROFESSIONALS

  • FDA has approved label changes that reserve the use of fluoroquinolone antibacterial medicines when treating acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) for patients who do not have alternative treatment options.

  • FDA has also updated the Boxed Warning and the Warnings and Precautions sections of the labels and revised the patient Medication Guide of the fluoroquinolone drug class to describe the serious risk of multiple disabling and potentially irreversible adverse reactions that can occur together.

  • These adverse reactions primarily include tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects.

  • The adverse reactions can occur within hours to weeks after starting treatment with a fluoroquinolone medicine.

  • Discontinue the fluoroquinolone medicine immediately at the first signs or symptoms of any serious adverse reaction.

  • Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with fluoroquinolones.

  • Serious Adverse reactions of the musculoskeletal system and peripheral nervous system include:

    • Tendinitis/Tendon rupture

    • Muscle pain

    • Muscle weakness

    • Joint pain

    • Joint swelling

    • Peripheral Neuropathy

    • Serious Central nervous system effects include:

      • Psychosis
      • Anxiety
      •  Insomnia
      • Depression
      • Hallucinations
      • Suicidal thoughts
      • Confusion
    • Other adverse reactions include:

      • Exacerbation of myasthenia gravis
      • Prolongation of the QT interval
      • Hypersensitivity reactions/anaphylaxis
      • Photosensitivity/phototoxicity
      • Blood glucose disturbances
      • Clostridium difficile-associated diarrhea
    • Encourage patients to read the Medication Guide that they receive with their fluoroquinolone prescriptions.

    • FDA convened a public advisory committee meeting in November 2015 to discuss the risks and benefits of fluoroquinolone antibacterial medicines for the treatment of ABS, ABECB, and uncomplicated UTI. We also communicated safety information associated with fluoroquinolones in May 2016, August 2013, and July 2008.

    • Report adverse reactions involving a fluoroquinolone or any drug to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

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Levaquin/levofloxacin Warning Label Changes (Please see July, 2016 Drug Safety Labeling Changes for the other fluoroquinolone label changes:

BOX WARNING (revised)

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including LEVAQUIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions, reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

WARNINGS AND PRECAUTIONS

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)
  • Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting LEVAQUIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue LEVAQUIN immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including LEVAQUIN, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture replaces Tendinopathy
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting LEVAQUIN, or as long as several months after completion of fluoroquinolone therapy… Tendinitis and tendon rupture can occur bilaterally.
  • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue LEVAQUIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including LEVAQUIN, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy (new sentences added)
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
  • …minimize the development of an irreversible condition…Avoid fluoroquinolones, including LEVAQUIN, in patients who have previously experienced peripheral neuropathy.

ADVERSE REACTIONS

  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
    • Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
    • Tendinitis and Tendon Rupture (replaces Tendon Effects)

PATIENT COUNSELING INFORMATION

Serious Adverse Reactions
  • Advise patients to stop taking LEVAQUIN if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN or other fluoroquinolone use:
  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of LEVAQUIN and may occur together in the same patient. Inform patients to stop taking LEVAQUIN immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
  • Tendinitis and tendon rupture replaces Tendon Disorders

MEDICATION GUIDE

What is the most important information I should know about LEVAQUIN?

Tendon rupture or swelling of the tendon (tendinitis).

  • Stop taking LEVAQUIN immediately and get medical help right away…
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking LEVAQUIN. (addition)

What is LEVAQUIN?

  • LEVAQUIN should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • LEVAQUIN should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.

Before you take LEVAQUIN, tell your healthcare provider if you:

  • have a disease that causes muscle weakness (myasthenia gravis); LEVAQUIN should not be used in patients who have a known history of myasthenia gravis.
  • have nerve problems; LEVAQUIN should not be used in patients who have a history of a nerve problem called peripheral neuropathy

How should I take LEVAQUIN?

Do not skip any doses of LEVAQUIN, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:

  • you have nerve problems. See “What is the most important information I should know about LEVAQUIN?”

  • you have central nervous system problems. See “What is the most important information I should know about LEVAQUIN?”

     

All help in spreading the word about these FDA warnings will be greatly appreciated!

 

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Updated Black-box Warnings for Fluoroquinolones

In July, 2016, the FDA made significant changes to the warning labels for all fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, Noroxin/norfloxacin, and Factive/gemifloxacin). These label changes include black-box warnings for fluoroquinolones that state:

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture 
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

You can view all of the updated fluoroquinolone labels HERE.

These updated black-box warning labels are HUGE steps in the right direction. The FDA is acknowledging, in a highlighted black-box section of the warning labels, that fluoroquinolone adverse-effects can be serious, irreversible, and disabling. They’re also acknowledging peripheral neuropathy and central nervous system effects, in addition to the adverse-effects on tendons, in the black-box warning. Additionally, the black-box warning states explicitly that fluoroquinolones should not be used for treatment of patients with chronic bronchitis, uncomplicated cystitis (I wish they would have said “urinary tract infections” instead of “cystitis” as they did in the hearings and preliminary documentation), and sinusitis, unless there are no alternative treatment options.

If this updated black-box warning had been in place when fluoroquinolones were first introduced to the market (in the 1980s and 1990s), many people would have been saved from being “floxed.” If these warnings had been in place when fluoroquinolones entered the market, or even when people started screaming about the significant damages and injuries caused by fluoroquinolones, perhaps more doctors would be aware of the dangers of these drugs, and they would be used more appropriately (only in life-or-death situations where there are no alternatives available). Currently, unfortunately, most people are not aware of the devastating effects of fluoroquinolones. Hopefully this updated black-box warning label will enlighten both patients and physicians about the serious and severe dangers of fluoroquinolones.

Prior to this update, the black-box warning for Cipro (and other fluoroquinolones) stated:

Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis (see WARNINGS).

This 2008 black-box warning was hard fought for, as both Bayer and Ortho-McNeil-Janssen (a subsidiary of Johnson & Johnson) wanted to bury the risks of tendon ruptures in small-text embedded in the warning labels, rather than highlighting the increased risk in a black-box warning. It was only after Public Citizen sued the FDA that this black-box warning was added to fluoroquinolone warning labels.

Though the old black-box warning was a significant victory at the time, it left much to be desired. The statement that, “This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants,” suggests that those who are under 60 years of age, not taking corticosteroid drugs, and who have not had kidney, heart, or lung transplants, can safely take fluoroquinolones. Though it is also noted that the risk of tendon ruptures is increased for people of “all ages,” it is common to hear of people being told that they wouldn’t have problems with fluoroquinolones because only older people, or people with myasthenia gravis, are at risk for experiencing adverse-effects. This simply isn’t true, as there are thousands of people who have been hurt by fluoroquinolones who are under the age of 60, do not have myasthenia gravis, who are not on corticosteroid drugs, and who have not had an organ transplant.

The old black-box warning gave people (both patients and physicians alike) the impression that fluoroquinolones are only unsafe for certain, small sections of the population. The truth is, fluoroquinolones can cause devastating, severe, disabling adverse-reactions in people who are young and old, strong and weak, fit and out-of-shape, and, at this time, there is no way to determine who will have an adverse-reaction and who won’t. There are almost certainly factors that predispose some people toward having devastating adverse-reactions to fluoroquinolones while others seem to be able to take fluoroquinolones without problem, but we don’t know what those predispositions are. No one knows if people who have latent autoimmune or endocrine system disorders, or who have MTHFR genetic mutations, or who are G6PD deficient, or who have leaky gut, or who have been exposed to heavy metals, or any other potential risk factor, are more succeptible to fluoroquinolone adverse-reactions than anyone else. There is a dice-roll, a pull of the Russian roulette trigger, every time ANYONE takes a fluoroquinolone because NO ONE knows what the real risk factors are, or even how frequent/rare adverse-reactions are. I wish that it was explicitly said on the fluoroquinolone warning labels, preferably in the black-box warning, that risk-factors are currently unknown and that everyone who takes fluoroquinolones is potentially at risk for experiencing disabling adverse-effects.

I also wish that it was noted in the black-box warning that adverse reactions to fluoroquinolones can be delayed for weeks, months, or even years after administration of the drugs has ceased. And I wish that people were warned that ceasing administration of the drug may not stop the adverse-reaction, and that the symptoms of fluoroquinolone toxicity can continue long after the drug “should” be out of one’s system.

I also wish that the danger of co-administering fluoroquinolones and corticosteroid drugs had stayed in the black-box warning, and I wish that the contraindication of NSAIDs and fluoroquinolones was noted in the black-box warning.

I wish that “cystitis” was changed to “urinary tract infection,” or that they were both mentioned as ailments for which the use of fluoroquinolones is not appropriate unless there is no alternative. I also wish that prostatitis and travelers’ diarrhea were added to the list of ailments for which fluoroquinolones should not be used unless there is no alternative.

Perhaps the next iteration of the black-box warning on fluoroquinolones will note those things. I wish I, and my doctor, had been warned more thoroughly about the dangers of fluoroquinolones before she prescribed them to me, and before I took them. Hopefully the updated black-box warning label will help physicians and patients to realize how dangerous fluoroquinolones are, and will keep many people from getting “floxed.”

Though the updated black-box warnings still leave a bit to be desired, they are a HUGE step in the right direction. Acknowledgement from the FDA that fluoroquinolone adverse-effects can be irreversible and disabling, and that they should not be used to treat many common conditions unless there are no other treatment options available, is very big news, and it should be celebrated. We are making progress, and hopefully fewer people will be hurt by fluoroquinolones because of these black-box warning updates.

 

 

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Fluoroquinolones Removed From the Market

Several fluoroquinolones have been removed from the market because they caused acute toxicity and death. The fluoroquinolones that have been removed from the market are not terribly different from the ones that remain on the market in terms of damage done or damage mechanisms.

Here are some of the fluoroquinolones that have been removed from the market:

Omniflox/temafloxacin

In 1992 the fluoroquinolone antibiotic Omniflox/temifloxacin was removed from the US market after causing three deaths.

To note the removal from the market, the FDA released the following statement:

            “The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.

This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing.

Temafloxacin was approved in late January 1992 and marketed in mid-February.  Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths.  There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function.  Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolitic anemia (destruction of red blood cells) and other blood cell abnormalities.”

The fluoroquinolones that remain on the market also impair kidney function. From the 2013 Science Daily article, Risk of kidney disease doubled with use of fluoroquinolone antibiotics, “The risk of acute kidney disease is doubled for people taking oral fluoroquinolone antibiotics, according to a new study.” The article pointed out that the risk of acute kidney disease was increased for patients taking cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin and floxin/ofloxacin – fluoroquinolones that remain on the market today.

The fluoroquinolones that remain on the market also cause blood-sugar abnormalities, including severe low blood sugar. A large 2013 study out of Taiwan looked at more than 78,000 patient records and found that, “The researchers found that patients with diabetes who had taken fluoroquinolone antibiotics had higher rates of both hyperglycemia and hypoglycemia compared with those who had taken macrolide antibiotics.” (source) Additionally, in the article, Fluoroquinolone antibiotics and type 2 diabetes mellitus, it is noted that, “Exposure to fluoroquinolone antibiotics is postulated as a risk factor for subsequent development of type 2 diabetes. It is hypothesized that fluoroquinolones induce an intracellular magnesium deficit that can lead to insulin resistance.”

Raxar/grepafloxacin

Raxar/grepafloxacin was removed from the worldwide market in 1999. The FDA withdrawal notice stated:

RAXAR is a fluoroquinolone antibiotic indicated for the treatment of infections caused by strains of bacteria susceptible to grepafloxacin in the following diseases: community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis; uncomplicated gonorrhea (urethral in males and endocervical and rectal in females); non-gonococcal urethritis and cervicitis.

Glaxo Wellcome has recently concluded an extensive review of the safety of RAXAR and determined that due to an effect of RAXAR on cardiac repolarization, manifested as QT interval prolongation on the electrocardiogram (ECG), some patients may be at risk of a very rare but serious ventricular arrhythmia known as torsade de pointes when treated with the product.

The warning label for Levaquin/levofloxacin (and the other fluoroquinolones that remain on the market) notes that:

“Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.”

Additionally, a study entitled “Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death” compared the risk of cardiac arrhythmia for U.S. Veterans taking amoxicillin, azithromycin and levofloxacin. The study concluded that:

“Compared with amoxicillin, azithromycin resulted in a statistically significant increase in mortality and arrhythmia risks on days 1 to 5, but not 6 to 10. Levofloxacin, which was predominantly dispensed for a minimum of 10 days, resulted in an increased risk throughout the 10-day period.”

Just like Raxar/grepafloxacin, the fluoroquinolones that are still on the market prolong the QT interval and cause torsade de pointes, which can lead to arrhythmia and death.

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Zagam/sparfloxacin

Zagam/Sparfloxacin was also removed from the market because it caused QT interval prolongation.

Zagam/Sparfloxacin also caused incidents of Stevens Johnson Syndrome:

“When a patient using  Zagam develops SJS or TEN after taking the fluoroquinolone antibiotic treatment, the individual’s topmost skin cells die and fall off. This leaves the deeper layers exposed and unprotected, making it likely for a patient to experience infection and scarring. The sensitive mucous membrane also becomes exposed when the upper layer of skin sloughs off, and may be prone to blistering.” (source)

Trovan/trovafloxacin

Trovan/Trovafloxacin was removed from the market because of its high potential for inducing serious, sometimes fatal liver damage (hepatotoxicity). The wiki entry for Trovafloxacin notes that:

In June 1999 the U.S. Food and Drug Administration advised doctors to limit the prescription of Trovan after it had been found “strongly associated” with 14 cases of acute liver failure and six deaths. The FDA had received over 100 reports of liver problems in people taking Trovan, which was at that time being prescribed at a rate of 300,000 patients per month in the United States. Two days later the Committee for Proprietary Medicinal Products recommended to the European Commission that marketing approval of Trovan be suspended for a year.

One of the best articles about the hepatotoxicity of Trovan/Trovofloxacin is Trovafloxacin, a fluoroquinolone antibiotic with hepatotoxic potential, causes mitochondrial peroxynitrite stress in a mouse model of underlying mitochondrial dysfunction. The article, Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria, by some of the same authors, is also enlightening. Liver damage, mitochondrial damage, and ROS overload/oxidative stress are all intricately connected. I highly recommend that you read the two articles linked to (but, man, they’re both really difficult articles). I suspect that both articles hold many of the keys to understanding all fluoroquinolone toxicity reactions. In the post, Article Breakdown – “Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria,” I go over some of the implications Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria has for floxies.

Interestingly, Trovan/Trovafloxacin has another area of shady history. In Kano, Nigeria, it was used in an improperly conducted trial on children with meningitis. Per the wiki entry for Trovafloxacin:

In 1996, during a meningitis epidemic in Kano, Nigeria, the drug was administered to approximately 200 [3] infected children. Eleven children died in the trial: five after taking Trovan and six after taking an older antibiotic used for comparison in the clinical trial. Others suffered blindness, deafness and brain damage, common sequalae of meningitis that have not been seen in patients treated with trovafloxacin for other infection types.[4][5][6] An investigation by the Washington Post concluded that Pfizer had administered the drug as part of an illegal clinical trial without authorization from the Nigerian government or consent from the children’s parents.[7] The case came to light in December 2000 as the result of an investigation by The Washington Post, and sparked significant public outcry. The most serious error was the falsification and backdating of an ethics approval leader by the lead investigator of the trial, Dr. Abdulhamid Isa Dutse. Dr. Dutse is now the chief medical officer of Aminu Kano Teaching Hospital. The result of the trial was that children treated with oral trovafloxacin had a 5% (5/100) mortality rate compared to a 6% (6/100) mortality rate with intramuscular ceftriaxone.

Between 2002 and 2005 the victims of the Trovan tests in Nigeria filed a series of unsuccessful lawsuits in the United States. However, in January 2009, the United States Court of Appeals for the Second Circuit ruled that the Nigerian victims and their families were entitled to bring suit against Pfizer in the United States under the Alien Tort Statute. A US$75 million settlement with the State of Kano was reached July 30, 2009.[8] Additionally two lawsuits also remain pending in New York, United States.[8] According to Wikileaked US embassy cables, Pfizer’s country manager admitted that “Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.”[9]

Additional information about the Kano trial can be found in The Guardian article, Pfizer pays out to Nigerian families of meningitis drug trial victims.

Tequin/gatifloxacin

Tequin/Gatifloxacin was pulled from the market because it caused severe blood sugar reactions such as hyperglycemia and hypoglycemia.

The New England Journal of Medicine article, Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults, noted that:

“Between April 2002 and March 2004, we identified 788 patients treated for hypoglycemia within 30 days after antibiotic therapy. As compared with macrolide antibiotics, gatifloxacin was associated with an increased risk of hypoglycemia (adjusted odds ratio, 4.3; 95 percent confidence interval, 2.9 to 6.3). Levofloxacin was also associated with a slightly increased risk (adjusted odds ratio, 1.5; 95 percent confidence interval, 1.2 to 2.0), but no such risk was seen with moxifloxacin, ciprofloxacin, or cephalosporins. We then identified 470 patients treated for hyperglycemia within 30 days after antibiotic therapy. As compared with macrolides, gatifloxacin was associated with a considerably increased risk of hyperglycemia (adjusted odds ratio, 16.7; 95 percent confidence interval, 10.4 to 26.8), but no risk was noted with the other antibiotics. Risks were similar in the two studies regardless of the presence or absence of diabetes.”

A more recent study, that looked at a larger population than the NEJM study, Risk of Severe Dysglycemia Among Diabetic Patients Receiving Levofloxacin, Ciprofloxacin, or Moxifloxacin in Taiwan, found that all of the fluoroquinolones on the market increased the likelihood of both hyper and hypo glycemia in diabetic patients:

“A total of 78 433 diabetic patients receiving the antibiotics of interest were included in the study. The absolute risk of hyperglycemia per 1000 persons was 6.9 for moxifloxacin and 1.6 for macrolides. In contrast, the risk of hypoglycemia was 10.0 for moxifloxacin and 3.7 for macrolides. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of levofloxacin, ciprofloxacin, and moxifloxacin compared with macrolides were 1.75 (1.12–2.73), 1.87 (1.20–2.93), and 2.48 (1.50–4.12), respectively, for hyperglycemia and 1.79 (1.33–2.42), 1.46 (1.07–2.00), and 2.13 (1.44–3.14), respectively, for hypoglycemia. Patients taking moxifloxacin faced a significantly higher risk of hypoglycemia than those receiving ciprofloxacin. A significant increase in the risk of hypoglycemia was also observed among patients receiving moxifloxacin concomitantly with insulin (AOR, 2.28; 95% CI, 1.22–4.24).”

As mentioned in the Temafloxacin section of this post, fluoroquinolone use has been linked to development of diabetes. Given that all fluoroquinolones cause blood-sugar dysregulation, and two fluoroquinolones have been removed from the market because they caused severe blood-sugar fluctuations, perhaps fluoroquinolones are behind the dramatic increase in both type 1 and type 2 diabetes over the last 30 years. It is a hypothesis that should certainly be looked into.

Conclusion

I struggle with whether or not I think all fluoroquinolones should be taken off the market. Even though I know that they are all dangerous, and sometimes even deadly, drugs, I also know that we are running out of antibiotics in our arsenal and that sometimes dangerous drugs are necessary in order to save a person’s life. I tend to think that Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and the other fluoroquinolones, should be severely restricted, and that there should be strict procedures followed when they are prescribed so that it is ensured that they will only be used in life-or-death situations where informed consent is given.

When looking at the fluoroquinolones that have been removed from the market, it always strikes me that they were removed from the market quickly after just a few deaths or a few studies that showed that they are dangerous drugs. The fluoroquinolones that remain on the market (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin) have also killed people. According to an FDA review with the subject, “Pediatric Exclusivity Postmarketing Adverse Event Review,” between 12/20/1996 and 08/27/2008, 924 people were killed by Levaquin/levofloxacin, including three children. The figures for Cipro/ciprofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin are similar. So, why do Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin have such staying power? Why are they still on the market when Temafloxacin/Omniflox, Raxar/grepafloxacin, Zagam /Sparfloxacin, Trovan/Trovafloxacin, and Tequin/Gatifloxacin have been removed from the market? I don’t know the answers to those questions–I wish I did. It seems to me that the FDA used to be a stronger, more independent, more effective organization than it is today, and that it used to actually pull dangerous drugs from the market.

Rather than removing dangerous fluoroquinolones from the market, or even imposing meaningful restrictions on the fluoroquinolones that remain on the market, the FDA has instead chosen to increase the size of the fluoroquinolone warning labels. As I have noted before, changed warning labels open the door for lawsuits and that’s a good thing, but it is overall a useless move that is devoid of real change. Not enough doctors or patients read warning labels, and they are a lousy way to communicate the real risks of pharmaceuticals.

The fluoroquinolones that remain on the market are not significantly different from the fluoroquinolones that have been removed from the market. Updating warning labels isn’t keeping people from getting hurt by these dangerous drugs. I understand hesitation to remove them from the market completely, but there should be significant restrictions put on their use. Right now they are not being used prudently or appropriately. That must change. Too many people are being hurt by these dangerous drugs.

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Prescription for Disaster – 22 years later

Bitter Pills Fluoroquinolone Toxicity Book

In Stephen Fried’s 1994 Washington Post article, Prescription for Disaster, Fried describes his wife Diane’s terrifying reaction to Floxin (ofloxacin), a fluoroquinolone antibiotic. It’s a wonderful, award-winning article on which Fried’s follow-up book, Bitter Pills: Inside the Hazardous World of Legal Drugs, was based. I highly recommend that you read both the article and the book.

This quote from Prescription for Disaster summarizes both well:

“Before Diane’s frightening experience, I had always thought of prescription drugs as pretty much idiot-proof. Your doctor tells you to take them, so you do, assuming that the worst that can happen is they won’t work. It turns out the worst that can happen is that you drop dead. The next worst is that your body is permanently damaged. Less worse, but still not very good, is that you suffer for hours, days or weeks with something your doctor may or may not recognize as a drug reaction — from one drug or an interaction. It may or may not go away by itself.”

Though both Prescription for Disaster and Bitter Pills are about the hazards of prescription drugs generally, both have quite a bit of information about fluoroquinolone toxicity, and Diane’s personal story of a severe CNS adverse reaction to Floxin is discussed in-depth.

In Prescription for Disaster, Fried notes:

“I KEEP WANTING this story to end, but it never does. Late last year I got a call from a producer of Oprah Winfrey’s show. She wanted to do a program on adverse drug reactions because she had just had one — to Floxin. Diane and I appeared on the program, along with several other people we had met through the original article, and since then I’ve gotten a steady stream of calls. Many of them are from people who had almost the same reaction Diane did, but weren’t as lucky to have doctors who at least recognized a drug reaction and were willing to learn what they didn’t know about how to treat it. I’ve talked to people whose spouses have lost their careers in the aftermath of drug reactions, people whose fathers attempted suicide because of depression that seemed to have been triggered by quinolones.”

We all want this story to end. More than 22 years later (Prescription for Disaster was published in April, 1994), it is still going on. Thousands of people are hurt every year by fluoroquinolones. People are experiencing tendon ruptures that leave them in horrible pain, exhaustion that leaves them bed-bound, gastro-intestinal issues that leave them unable to eat, CNS issues that leave them unable to work, peripheral neuropathy that leaves them in permanent pain, and more. I sincerely hope that the story of people becoming chronically ill and disabled after taking Cipro, Levaquin, Avelox, Floxin, or their generic equivalents, ends soon. It’s not a good story, it would be nice if it ended sooner rather than later.

On the WONDERFUL site, http://fluoroquinolonethyroid.com/, the author notes the following about the publication of Prescription for Disaster in 1994:

For anyone who thinks that the FQ ADR’s are something new, think again. It’s an old, old story, this one, which actually goes back much farther than 1994. But this article highlights how Pharma, FDA, flox victims, the ignorant and dismissive medical profession, even publicity on shows like GMA, Dateline, Donahue, and even Oprah — they were all there —  it’s all happened before — way back in 1994. It’s all been completely ignored; and in fact, sales of FQ’s continued to increase and soar exponentially during the past 20 years. I, and who the hell knows how many others just like me, have been “floxed” since then. Had the FDA, Pharma, and the medical profession done their job back then, my life (and many others) might have been spared.

Don’t think Pharma or the FDA is just finding out about these ADR’s now. They’ve known. They’ve known for a very, very, long time. And they’ve done absolutely nothing about it.

So when you hear all the Pharma companies make their same old tired and outright spurious statements over and over again about how “Safety is our greatest concern, and these antibiotics have been prescribed safely for the last 20-30 years without problems,“ and the FDA says “We take these safety issues very seriously and are looking into it,“ you’ll know what bullshit that is. There is a historical record accumulating, and this article is just one example for you to post in rebuttal.    Remember:  the internet saves everything now. There will be less and less places for Pharma to hide as time goes on and the number of victims the world over continue to grow.

FQ’s are once again in the news. We can only hope that this time, it will be different.

Yes, we can hope that this time will be different. We need to stay vigilant though, and continually push, so that the pharmaceutical companies, the FDA, and even many doctors and nurses cannot get away with the lies of, “Fluoroquinolones have an excellent record of safety and efficacy,” and, “Side-effects are rare,” and, “There is no known mechanism for fluoroquinolones to cause multi-symptom, chronic disease,” and, “Multi-symptom, chronic diseases are in patient’s heads – they don’t really exist,” and, “Fluoroquinolones aren’t connected with autoimmune diseases, fibromyalgia, ME/CFS, POTS, arthritis, psychiatric illnesses, thyroid autoimmune diseases, etc.” Those lies have been told over and over again since fluoroquinolones first entered the market in the 1980s. Repetition doesn’t make them true, but it sure helps to reinforce the lie.

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There is plenty of evidence that fluoroquinolones are dangerous, destructive drugs that can lead to chronic illness and disability for many. There is also evidence that the mitochondrial destruction done by fluoroquinolones is similar to that of mitochondrial destruction found in people with autoimmune and other “mysterious” diseases. The evidence isn’t even new. They’ve known since 1994 that these drugs are damaging to the point of being disabling. They know, they just choose not to do anything meaningful about it. It is possible to put meaningful restrictions on dangerous drugs that ensure that they are only used when appropriate (in life-or-death situations) and that proper informed consent is given before the drugs are administered. Rather than making these meaningful changes though, the FDA and the pharmaceutical companies have chosen to largely ignore the problem.

Everyone who has gotten “floxed” since 1994 has been hurt because of willful ignorance on the part of the FDA. They claim, over and over again, that these reactions are new, and that they’re just now hearing about them. I realize that news sinks in slowly in a bureaucratic institution like the FDA, but 22 years is ridiculous and, frankly, unacceptable. They knew that these drugs were dangerous then, because people told them back then. They know that these drugs are dangerous now, because people have told them again. Research has also accumulated since 1994, and there are hundreds, if not thousands, of articles about the dangerous effects of fluoroquinolones published in journals (here’s a sampling of just a few – https://floxiehope.com/fluoroquinolones-links-resources/).

When is this going to stop? When will the FDA start doing it’s job and adequately regulating these dangerous drugs? How many more people have to get hurt by fluoroquinolones? How many more times do we have to scream at them and tell them what they already know – what they have known for more than 22 years – that fluoroquinolone adverse reactions are severe and devastating? It’s ridiculous. This mess should have been stopped 22 years ago. The FDA should have made meaningful changes to prescription guidelines for fluoroquinolones in the 1990s. If not then, they should have done so in 2008 when Public Citizen sued the FDA in order to get the black box warning about tendon ruptures added to the fluoroquinolone warning labels. Since meaningful reform didn’t happen then, how about now? The FDA just had a hearing about the risks of fluoroquinolones, and found that the risks outweigh the benefits in treatment for many common infections. They have the opportunity to enact meaningful change now, and they should do so.

I doubt that they will make meaningful, appropriate changes though. Business will go on as usual. People will continue to be hurt by fluoroquinolones. People who should know better (FDA personnel, Pharma scientists, doctors, etc.) will insist on saying that these adverse-reactions are rare, and thus insignificant and untrue. It’s a shame, because they are incorrect. These adverse reactions are severe, devastating, and not near as rare as they should be.

So… we have to keep screaming. We have to keep telling the news media about our reactions, writing to anyone who might listen, filing reports with the FDA, writing articles and blog posts, petitioning scientists, talking to friends, sharing articles, etc. We have to keep banging the drum until they listen.

I’m not sure how long this process will take. It’s been 22 years since Prescription for Disaster was published. I hope that it doesn’t take 22 more.

 

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FDA Advises Restricting Fluoroquinolone Use

May 12 flox victory

On May 12, 2016 the FDA released the announcement, Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections. It stated:

FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

This is huge, wonderful news for the “floxie” community!

The middle paragraph of the FDA announcement is particularly gratifying. The FDA is acknowledging that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin) are associated with “disabling and potentially permanent serious side effects that can occur together.” They are acknowledging that fluoroquinolones can lead to multi-symptom chronic illness, and that’s HUGE! Fluoroquinolones don’t only cause one or two of the side-effects listed on the warning label in isolation, they cause a syndrome of illness. For the FDA to acknowledge this is an enormous step in the right direction. (More on the FDA’s acknowledgement of Fluoroquinolone Associated Disability, FQAD, can be found in the post, “An Official Name: Fluoroquinolone-Associated Disability (FQAD).”)

This acknowledgment from the FDA grew out of thousands of people reporting their symptoms to the FDA, speaking out to the media, and testifying before the FDA.

The change in fluoroquinolone warning labels stemmed from the November 5, 2015 meeting of the FDA’s Antimicrobial Drugs Advisory Committee meeting to discuss, “the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.” Hundreds of victims of fluoroquinolones, as well as doctors, attorneys, journalists, and other supporters, attended the Antimicrobial Drugs Advisory Committee meeting, where 30+ people were able to tell their story of how fluoroquinolones had devastated them and their loved ones–causing multi-symptom, chronic illness that resulted in disability and even death for many. The transcript from the meeting can be found HERE. The committee listened, and ruled that the current warning labels on fluoroquinolones were not sufficient, and that fluoroquinolones are not appropriate for use in treating minor infections.

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Because the FDA has a history of not doing as their committees request, and because action can take years, those in the fluoroquinolone injured community weren’t sure whether or not the victorious ruling at the committee level would translate into changes to the actual warning labels. However, on May 12, 2016 the FDA made the announcement that the warning labels for fluoroquinolones would change to note that the risks of fluoroquinolones outweigh their benefits in the treatment of patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. The announcement, and the ensuing warning label changes, mark a moment of victory and vindication for victims of fluoroquinolones

Though many people don’t think that changing the warning labels is enough (and they have very good, legitimate reasons for thinking that warning label changes are inadequate), it is a step in the right direction. With warning label changes, perhaps doctors will acknowledge fluoroquinolone toxicity and restrict their use of fluoroquinolones. Additionally, warning label changes open doors for lawsuits, and lawsuits have the power to hurt the pharmaceutical companies and help victims of fluoroquinolones to gain justice. If the warning label changes include language like, “An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.” the door will be open for many floxies with many symptoms to sue Bayer and Johnson & Johnson, the makers of Cipro, Levaquin and Avelox. Lawsuits, if successful, may bring about change in the distribution of fluoroquinolones, and may also help victims of fluoroquinolones to gain justice and possibly even healing.

The FDA announcement has also led to media coverage, and with media coverage comes additional awareness. The word is spreading far and wide as to how dangerous these drugs are.

The FDA announcement is a massive step in the right direction, and May 12, 2016 is a very good, victorious, vindicating day for victims of fluoroquinolones. It is a day to celebrate!

Cheers, my friends!

 

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Who Knows About Fluoroquinolone Toxicity?

There are people who should know about the dangers of fluoroquinolone antibiotics.

The FDA should know about the dangers of all the drugs on the market. There should be people at the FDA who have read the 200+ articles I have HERE about the damage that fluoroquinolones do to cells. And there should be people at the FDA who track adverse drug reactions and therefore realize that adverse reactions to fluoroquinolones involve multi-system, often chronic, illness and disability. There should be people at the FDA who realize that a 43 page warning label for Cipro/ciprofloxacin is an indication that it’s a dangerous drug, and there should be people at the FDA who push for restrictions on drugs that carry black-box warnings–the most severe warnings possible before a drug is removed from the market. It’s the JOB of the FDA to regulate drugs and to protect the public from drugs whose benefits don’t outweigh their risks. The powers-that-be at the FDA should be working toward more prudent and appropriate use of fluoroquinolones, because it’s their job (and duty, and mission, and moral obligation) to do so.

Doctors should know about the dangers of fluoroquinolones because they prescribe them, and it’s not too much to ask that doctors know the side-effects of the drugs they prescribe. We, as patients, also ask that our doctors recognize adverse drug reactions when they see them. It would be even nicer if they could cure us and reverse adverse drug reactions, but maybe that’s asking too much. Some knowledge about the dangers of the drugs they prescribe isn’t too much to ask for though.

Pharmacists should realize that fluoroquinolones are dangerous drugs. They study drugs much more extensively than doctors do, and they’re the last line of defense before a patient receives a prescription, so it’s expected that they should know about the risks associated with all the drugs they dispense.

It is expected that all of these people will not only know about the dangers of the drugs they regulate, prescribe or dispense, but also that they will protect patients/consumers from using them inappropriately and getting hurt by them unnecessarily.

I don’t think that it’s too much to expect, and I think that some anger at the FDA, doctors and pharmacists is appropriate given their collective failure to minimize the damage done by fluoroquinolones.

There’s a problem with these assertions though. Even though the FDA, doctors and pharmacists SHOULD know about the dangers of fluoroquinolones and about fluoroquinolone toxicity, I don’t think they do.

I don’t think that they actually realize the severity of adverse reactions to fluoroquinolones. I don’t think that they realize that people who were previously healthy can have all aspects of their health and lives ruined by Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or any of the other fluoroquinolones.

It is too bizarre, and too unheard of, that a class of ANTIBIOTICS could cause multi-symptom, chronic, disabling illness. Fluoroquinolones are antibiotics, and even though medical professionals and regulators should know better, many believe all antibiotics are benign drugs.

As frustrating as it is for those of us who know first-hand how terrifying and destructive fluoroquinolone toxicity is, I think that it will behove us to recognize that, unfortunately, most doctors, pharmacists and even FDA personnel, don’t realize how dangerous fluoroquinolones are, or how devastating fluoroquinolone toxicity is to its victims.

I know of several physicians, pharmacists and scientists who have been “floxed.” They were just as blind-sided by their adverse reaction as anyone else. They didn’t know how severe and life-altering the effects of fluoroquinolones could be until they were personally affected by them.

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It can be difficult for those who have experienced fluoroquinolone toxicity to recognize, but many medical personnel truly didn’t know about fluoroquinolone toxicity. Doctors and pharmacists weren’t taught about fluoroquinolone toxicity in medical or pharmacy school, and the reactions are bizarre enough that they’re difficult to recognize in practice, so they don’t see it until it happens to them.

Unfortunately, I don’t think that the people at the FDA know either.

While listening to the FDA’s Antimicrobial Drugs Advisory Committee at the November 5, 2015 meeting to, “discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions,” I got the distinct feeling that the FDA committee members didn’t realize the extent of the damage that fluoroquinolones do. Even though their meeting brief noted that fluoroquinolones can cause disability, the committee members still seemed surprised by the severity of the adverse reactions described by victims of fluoroquinolones.

Though they seemed to hear those who testified, and they listened respectfully, I think that stories such as the following were a surprise to the committee members:

B.C (Before Cipro):  I was a hiker, biker (rode my bicycle across the US carrying 50 pounds), hockey player, horseback rider, swimmer; thin, fit, worked in moderately physically demanding profession, no known health issues other than a simple UTI.

A.C:  (After Cipro):  Five days and 10 pills later:  crippled with unrelenting pain, unable to walk, sit, stand, use arms, fingers, or type due to severe body-wide tendon pain; hallucinations, tinnitus;  central, autonomic, and peripheral neurological issues;  severe neuromuscular damage; vision and hearing issues;  severe endocrine abnormalities (glucose, thyroid); severe cardiac issues;  autoimmune issues.

A.C. Permanently :  Five years later:  Still suffering and disabled; can’t work, lost profession, lost financial security, lost marriage, lost hope for any reasonable quality of life.   Denied by medical profession due to no known diagnostic biomarkers; denied legal recourse due to generic; denied SSDI due to the first two and denial by the FDA and everyone involved, and ultimately, will be denied as the most probable cause of my death.

I don’t think that the FDA committee members were aware that fluoroquinolones could do that much damage. How could an antibiotic do that much damage? It’s unheard of, but it’s still true–fluoroquinolones can, and do, an immense amount of harm.

The FDA’s Antimicrobial Drugs Advisory Committee now knows about the harm that fluoroquinolones inflict. They sat through our testimony and they can no longer claim ignorance. They were told, in no uncertain terms, about the devastation that fluoroquinolones have brought to people’s lives. They acknowledged that the warning labels currently on fluoroquinolones do not appropriately convey the risks involved with taking these dangerous drugs to treat simple infections.

The FDA needs to convey to doctors, pharmacists, and the public, that fluoroquinolones are dangerous drugs with severe side-effects, and that it’s not appropriate to use them for treatment of simple infections. If the FDA updates the warning labels on fluoroquinolones to note that fluoroquinolone associated disability is a possible effect, maybe more doctors and pharmacists will recognize that they should not only avoid these drugs themselves, but that they should avoid them for use in patients too.

We, as victims of fluoroquinolones and patient advocates, are screaming loudly about the devastating effects of fluoroquinolones. There have been hundreds of news stories over the last year about the dangers of fluoroquinolones. The November 5th FDA committee hearing was a resounding success. The term “flox” is becoming recognized, and people who have not been “floxed” themselves are recognizing what it means when someone says, “I am bed-bound and I lost my job because I got floxed.” The word is getting out and those doctors and pharmacists who are paying attention are recognizing that fluoroquinolones are consequential drugs. At some point we will be able to say, “you should have known” when confronting a doctor or pharmacist about a fluoroquinolone toxicity reaction. Right now though, many doctors, pharmacists and even FDA personnel, don’t know how horrible fluoroquinolone toxicity reactions can be.

Our “bottom-up” efforts are making a difference, but some “top-down” efforts are sorely needed too. The FDA must thoroughly communicate the dangers of fluoroquinolones to doctors, pharmacists and patients.

Ignorance is not bliss when millions of fluoroquinolone prescriptions are being handed out, and thousands of people are being devastated by these dangerous drugs. Everyone involved in the medical system, including patients, needs to be informed about the dangers of these drugs. Currently, they are not. Currently, they don’t know about fluoroquinolone toxicity. Change is coming though. The more patients are listened to, the faster change will come. 

 

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Victory at the FDA

Lisa Testifying at the FDA

 

I wrote a post about the FDA committee hearing about the risks of fluoroquinolones for Hormones Matter. Here it is:

Victory at the FDA for Fluoroquinolone Victims

As Chandler Marrs noted when she posted it on Facebook (BTW, shares are appreciated!):

“Who’s to say the experts know more than the patients? They don’t. This took years of patients speaking out, all the while the experts were silent. I am so impressed with the folks who were ill themselves, but still managed to launch a movement that was finally recognized by the FDA. Though there is still much to do, their stories and their struggles provide a guide to others. Suffering in silence does no one any good. Speak out.”

Indeed. I am very proud of all of the floxies who made this happen. Thank you to all!

 

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Is Fluoroquinolone Toxicity “Real?”

What is required for fluoroquinolone toxicity to be “real?”

Most of the symptoms of fluoroquinolone toxicity are listed on the warning labels.

Tendinitis? Yup, listed on the warning label. Muscle weakness? Yup, that’s there too. Cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching? They’re right there on the warning label. Liver failure is there too – that’s what “hepatic failure” means. “Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving fluoroquinolones, including ciprofloxacin.” Serious central nervous system effects like, “dizziness, confusion, tremors, hallucinations, depression, and, rarely, psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide” are also listed on the warning labels. Permanent peripheral neuropathy is listed too. So are musculoskeletal disorders—though the warning label only notes that those happen in pediatric patients—kids. Prolongation of the QT interval, renal impairment, phototoxicity and diarrhea are also listed.

Do the warning labels leave some symptoms of fluoroquinolone toxicity out? Sure. Even the FDA acknowledges that, “While most of the individual AEs (adverse effects) that exist within FQAD (fluoroquinolone associated disability) are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not.” The warning labels are a good place to start though.

If someone takes a drug, then develops side-effects that are listed on the drug warning label, it’s pretty reasonable to think that what they’re experiencing is an effect of the drug. It’s not only reasonable, it’s probable.

If thousands of people experience similar adverse effects after taking a drug, those adverse effects are likely caused by the drug.

Thousands of anecdotes certainly help to build a case, but they are still anecdotes, so scientific experimentation is needed to show that a drug is as damaging and dangerous as people claim it to be.

There are more than 200 peer-reviewed journal articles about fluoroquinolones in the Research section of the Links & Resources page on this site. There is PLENTY of evidence that fluoroquinolones do a massive amount of damage to the human body.

There is PLENTY of evidence that fluoroquinolones damage mitochondria, increase ROS, deplete antioxidants, deplete iron, deplete magnesium, damage the microbiome, downgrade GABA, are endocrine disrupters, cause lysosomal disorders, form poisonous metabolites in the liver, activate mast cells and release histamine, AND MORE.

Can any one of those things cause a multi-symptom illness? Yes, of course they can. And fluoroquinolones DO cause multi-symptom, often chronic, illness.

Despite all that, there is not a diagnostic code for fluoroquinolone toxicity, and fluoroquinolone toxicity is not taught in medical school. Many doctors do not recognize fluoroquinolone toxicity when they have a patient who is dealing with it. (Though that is changing—more and more doctors are recognizing fluoroquinolone toxicity, and that is a very good thing.) And, despite all the damage that fluoroquinolones do to cells, there is no test that shows fluoroquinolone toxicity.

A diagnostic code and a test will likely be required for some people to believe that fluoroquinolone toxicity is real. We should fight for those things, because they’re important in getting the problem recognized and the solution sought.

Even without the diagnostic code or adequate test, fluoroquinolone toxicity IS REAL. It is acknowledged in FDA documents and backed up by hundreds of peer-reviewed articles. If someone chooses to ignore that evidence, well, they’re operating on faith in their notions of infallible doctors, not the real, scientific evidence that shows the damage that fluoroquinolones do to cells.

Regardless of what anyone thinks, your pain and your experience are real. I know that it hurts when people assert that your pain isn’t real, or that you’re imagining what you know to be true. It sucks, to say the least. But you know your body, and you know what happened to you. Your truth, and your experience, matter. Other people’s beliefs about your condition don’t.

 

 

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An Official Name: Fluoroquinolone-Associated Disability (FQAD)

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the last post, I noted that the FDA report said that fluoroquinolones have not been shown to be any better than a placebo at treating sinus infections, bronchitis in those with COPD, or uncomplicated urinary tract infections. In this post, I will point out that the FDA has given those suffering from fluoroquinolone toxicity an official name. Per the report:

“A review of the FDA Adverse Event Reporting System (FAERS) was performed to characterize a constellation of symptoms leading to disability that had been observed during FDA monitoring of fluoroquinolone safety reports. This constellation of symptoms will be referred to in this review as ‘fluoroquinolone-associated disability’ (FQAD). While most of the individual AEs that exist within FQAD are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

That recognition from the FDA is EXCELLENT progress!

I don’t know whether or not FQAD will be put into diagnostic manuals, or if it will be coded for in insurance systems. I hope that those are future steps that will be taken.

So far, in the first 20 pages of the 617 page FDA report, they have noted that fluoroquinolones are no more effective than placebos in treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. They have also noted that fluoroquinolones can cause a constellation of symptoms across multiple body systems, and that those symptoms can lead to disability.

It is not appropriate to cause, or even to risk, disabling adverse effects through utilization of a drug that is no more effective than a placebo at treating sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. I hope that the FDA changes the recommended uses for fluoroquinolones in recognition of this.

I hope that the naming of FQAD increases recognition of the horrible adverse effects of fluoroquinolones. With recognition, hopefully a more prudent and appropriate approach to use of fluoroquinolones will occur.

Post-publishing edit – While it is a wonderful step in the right direction that the FDA acknowledged that fluoroquinolones can cause a constellation of symptoms that is not adequately noted in the warning label, I may have jumped the gun a bit in calling it an “official” name. FQAD is the term that the FDA is using for the purposes of the November 5th hearing. It is not a diagnostic code that your doctor can look up in his or her diagnostic manuals yet. I hope that it’s a step in that direction, but we’re not there yet. Celebrating the FDA acknowledgement is in order, but we still have a ways to go. I apologize for not being more clear in the post before I originally published it!

 

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Advocacy Opportunity – FDA Meeting to Discuss Fluoroquinolones

ADVOCACY OPPORTUNITY 

The FDA (Food and Drug Administration) is holding a meeting on November 5, 2015 to discuss the benefits and risks of fluoroquinolones. Per the FDA notice, the agenda for the meeting is:

“The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

They are opening the meeting for public testimony and if you are in the Silver Spring, Maryland area I encourage you to attend the meeting and to testify at it. (I would love to go, but I’m in Colorado, so not exactly nearby.)

They are also accepting written testimony. Please send your story/testimony to Jennifer Shepherd, the contact person, by October 22, 2015. Jennifer’s contact information is:

Jennifer Shepherd, RPh.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: AMDAC@fda.hhs.gov

PLEASE take the time to tell your story to the FDA. The adverse effects of fluoroquinolones are too severe for it to be appropriate for them to be used for sinusitis or uncomplicated urinary tract infections. This is your opportunity to share your story directly with the FDA, and the committee that determines how fluoroquinolones are used.

More information can be found in these announcement links –

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm

https://www.federalregister.gov/articles/2015/10/01/2015-24836/joint-meeting-of-the-antimicrobial-drugs-advisory-committee-formerly-known-as-the-anti-infective

THANK YOU!!!

 

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Generic Drugs and (a lack of) Justice

IF YOU ARE HURT BY A GENERIC DRUG, YOU CANNOT SUE.  YOU HAVE NO RECOURSE WHATSOEVER.

What a sad state of affairs.

More information about this travesty can be found in the post, “HURT BY A GENERIC DRUG? VICTIMS HAVE NO RECOURSE UNLESS THE FDA CHANGES RULES” on Hormones Matter.

The FDA can change a rule and enable people who are hurt by generic drugs to gain the same level of recourse as those who are hurt by name-brand drugs.  I hope that the FDA does the right thing.

 

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Testifying for Justice for Victims of Generic Drugs

Thousands of victims of generic ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin have been unable to pursue legal recourse because of a couple of Supreme Court decisions that ruled that generic drug manufacturers cannot be held liable for harm caused by their products.

You can read more about these horrible Supreme Court decisions in this June, 2013 New York Times article, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs.

People are just as legitimately hurt by generic drugs as they are by name-brand drugs.  Arbitrarily taking justice away from a person because they were hurt by a generic drug is infuriating and wrong.

I have been given the opportunity to do something about this horribly unjust situation.

I have been invited by the American Association for Justice to speak at a Congressional Hearing on Capitol Hill on March 26th and to testify at a FDA hearing on March 27th regarding the lack of legal recourse for those hurt by generic pharmaceuticals.

This is a VERY exciting opportunity and I am honored to be able to tell Congress and the FDA about the harm that generic fluoroquinolones have done, and to encourage them to enact legislative changes that enable those who have been harmed by generic drugs to seek recourse and gain justice.

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Rachel Brummert, President of the Quinolone Vigilance Foundation, will also be presenting/testifying and you can learn more about what this opportunity will involve for both of us by reading the March 6th post on www.saferpills.org, “Executive Director Rachel Brummert speaking at Congressional Hearing and FDA Hearing.

It would be great if as many stories as possible about the pain caused by generic fluoroquinolones could be heard.  There are a couple of ways that you can share your story of pain caused by a generic fluoroquinolone, and the lack of justice available to you.

First, you can submit a comment to the FDA.  Instructions on how to do so can be found in the March 4th post on www.saferpills.org, “Generic Drug Victims: Share your story.”  I encourage EVERYONE to submit their story as a public comment.  Public comments really do make a difference!

Second, both Rachel and I would love to share some of your stories in our testimonies.  If you can please email either of us your stories, and what you would like us to say on your behalf to Congress and the FDA, we will appreciate it!  My email address is floxiehope@gmail.com and Rachel’s is Rachel@saferpills.org.  Rachel and I will coordinate so that we can tell as many stories as possible within the time allotted to us.  We can’t promise that we’ll be able to get to everyone’s story, and we will need to edit the stories for time and relevance, but we would love to share as many impactful stories as possible.  Please send either me or Rachel your stories / what you want us to say on your behalf, asap.  We need to get a drafts of what we are going to say to the American Association for Justice by the end of this week.  Sorry for the time crunch and thank you very much!

Thank you,

Lisa

 

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Petitioning the FDA – Comments Needed

Floxie friends, I have one thing that I am asking you to do today.  And please, if you decide to do it, do it sooner rather than later.  Please go to THIS LINK and make a comment about how fluoroquinolones have hurt you.  Let the FDA know that the current warning label for fluoroquinolones is insufficient.  Let the FDA know that their own findings of fluoroquinolone caused mitochondrial toxicity need to be noted on the warning labels of fluoroquinolones.

Again, here is the link for the citizens’ petition, filed with the FDA, where comments about how a fluoroquinolone hurt you can be made –

http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-0856

If you do nothing else today, please, please make comments on this petition.

Thank you!

HERE is the petition that I am asking you to comment on.

The petition was submitted by Dr. Charles Bennett, M.D., Ph.D., M.P.P.  Dr. Bennett is with the Center for Medication Safety and Efficacy and the Southern Network on Adverse Reactions (SONAR).  The Quinolone Vigilance Foundation facilitated much of the work that went into the petition.  I thank both Dr. Bennett and his colleagues, and the Quinolone Vigilance Foundation for their work!

The petition is to add “Possible Mitochondrial Toxicity” to the Levaquin label.  In the Warnings and Precautions section of the Levaquin/levofloxacin label, it should say:

Possible Mitochondrial Toxicity

Fluoroquinolones, including Levaquin, may cause Mitochondrial Toxicity due, in part, to an insufficiency of ATP. Mitochondrial conditions that are due to an insufficiency of ATP include developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, and lactic acidosis. Neurodegenerative diseases, like Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis (ALS) have been associated with the loss of neurons due to oxidative stress generated by reactive oxygen species (ROS) related to Mitochondrial Toxicity. Peripheral neuropathy, hepatoxicity, glucose disturbances, and phototoxicity may result from Mitochondrial Toxicity.

That language, by the way, is directly from the FDA document, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure.”  The folks at the FDA know that fluoroquinolones have been shown to be toxic to mitochondria, this petition is asking them to do something about it.

It is also requested in the petition that the following black box warning be added to the Levaquin/levofloxacin warning label:

WARNING: POSSIBLE MITOCHONDRIAL TOXICITY

Fluoroquinolones may cause Mitochondrial Toxicity. Mitochondrial Toxicity has been implicated in conditions such as peripheral neuropathy, hepatoxicity, glucose disturbances, phototoxicity, developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, lactic acidosis, Parkinson’s, Alzheimer’s, and amyotrophic lateral sclerosis (ALS).

Based on the severity of the effects of mitochondrial toxicity, it is being requested that:

  1. Levaquin label changes be made immediately.
  2. “Dear Doctor” letters be distributed regarding Levaquin label changes and requesting that physicians inform patients about the potential impact of “Possible Mitochondrial Toxicity” if they were previously prescribed this drug.

It is very important for all patients and medical professionals that this warning be added to the label of fluoroquinolones.  Please make your voice heard and support the petition with your comments.

THANK YOU!

 

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Fluoroquinolone Antibiotics Damage Mitochondria – FDA Does Little

Hormones Matter Logo2

The Pharmacovigilance folks at the FDA know that fluoroquinolones are damaging mitochondria.  Yet, they look the other way.  Adding a more severe warning about peripheral neuropathy to the warning label isn’t helpful.  People should know that they are increasing their risk of every chronic disease associated with mitochondrial damage and oxidative stress when they take a fluoroquinolone.  That would actually be helpful.

Here is the post, on Hormones Matter – http://www.hormonesmatter.com/fluoroquinolone-antibiotics-damage-mitochondria-fda-adds-warning/

 

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Email to the FDA

For the record, this email was sent to stephen.king@fda.hhs.gov on 10/11/2013.

Dear Mr. King,
When is it going to be recognized that fluoroquinolones are dangerous enough to severely restrict their use?  How many people have to suffer from permanent disability before their use is restricted to life-or-death situations in which there is no safer alternative treatment?
I thank you and the FDA for finally, after 30 years of complaints, updating the warning label for fluoroquinolones to include the risk of permanent peripheral neuropathy.  As someone who was severely adversely effected by Cipro in 2011, at the age of 32, who had extreme pain in my hands and feet, though I probably didn’t categorize them as “peripheral neuropathy” because I didn’t know the term until recently so my report to the FDA didn’t include that symptom, I found the label update to be somewhat vindicating.  However, it does not go near far enough.
Please consider the following:
  1. This article in Nature (http://www.nature.com/nature/journal/v501/n7465/full/nature12504.html) links topoisomerase inhibitors to the expression of Autism related genes.  As I’m sure you know, fluoroquinolones are topoisomerase inhibitors.
  2. Fluoroquinolones adduct to bacterial DNA, as described in this article – http://www.jbc.org/content/273/42/27668.full.  Please see the attached note from a retired toxicologist who was severely adversely effected by a fluoroquinolone, for a description of how fluoroquinolones adversely effect human DNA.  These drugs adduct to DNA, just like Agent Orange, and they are given out like candy.
  3. Recent media articles about how people have suffered severe CNS damage after being in the ICU.  Fluoroquinolones are utilized commonly in the ICU.  Perhaps it would behoove you to make the connection between the NEJM article noting that people stop being able to think after a visit to the ICU and the severe CNS effects of fluoroquinolones.  https://www.google.com/#q=nejm+patient+in+intensive+care+lose+memory  Also, Lynn Spalding, the patient who was being treated for a urinary tract infection whose body was found in the hospital stairwell was more than likely given fluoroquinolones to treat her UTI.  A severe adverse reaction could have caused the events that led to her death – http://www.cnn.com/2013/10/09/justice/body-in-hospital-stairwell/
  4. Please read the comments under the NYT article about the dangers of fluoroquinolones.  http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_r=1  NONE of these people are lying or exaggerating.  In fact, many have reactions that are more severe than they describe because it is quite difficult to verbalize your problems when EVERYTHING is going wrong in your body and mind.
If you have any desire to read my story, it can be found at www.floxiehope.com.  I have recovered, but my recovery does not make the fact that I was hurt (possibly on a DNA level) justified.  My urinary tract infection could have, and should have, been treated with a milder antibiotic.
The FDA is supposed to be protecting and informing patients.  Please move in that direction.
Please feel free to contact me if you have any questions or concerns.
Thank you,
Lisa Bloomquist
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Permanent

I really appreciate that the FDA has put the word “permanent” on the warning labels of fluoroquinolones.  “The nerve damage may be permanent” is now stated under the peripheral neuropathy section of the side-effects listed.  Permanent.  Physicians may take note; they can do permanent damage to their patients with these drugs.  It may make them think twice.  It may make them realize the severity of the adverse effects of fluoroquinolones.  They may see that they can do damage with these drugs that they can’t fix.  Permanent damage.

While it is wonderfully validating to see the words “The nerve damage may be permanent” on the updated label for Cipro, there’s a part of me that hates that word – permanent.  It’s a word that steals people’s hope.  It’s a word that feeds into fear, hopelessness and suicidal ideation. It’s a word of doom.

You are not doomed.  There is nothing about you that is permanent.  Nothing is permanently damaged.  Nothing is permanently perfect.  We are all in a state of flux, all the time.  Sure we’re all decaying a bit, it’s the nature of living things, but we are also growing and healing.  People recover from this.  They do.  I did.  Lots of other people have recovered too.  There are stories of hope and healing on this site.  Sure, it’s not a huge number of stories right now, but the site has only been up for a couple of months and, well, the people who have healed have moved on with their lives.  If I may be so audacious, I would say that MOST people recover, with time.  It’s a really long, rough, painful, scary road, but people get down it.  People get to the end.  They recover.  I hope that you can find the strength to believe that you will recover too.  If you can’t find that strength today, I hope that you can find it tomorrow.  Because this life is worth fighting for.  Not only your health, but your hope and your spirit are worth fighting for as well.

As someone said in one of the fluoroquinolone victim support group sites, “no side effect can be proven permanent until you’re dead.”  True.

So hang in there folks.  I know that it’s a trite thing to say, and I apologize for that, but I mean it.  Just take one breath at a time.  You can get through this.  Bayer and Johnson & Johnson may have kicked you, but they didn’t kill you.  You’re still here.  You can recover.  Have hope.  Try.  ‘Cause it’s only permanent if it kills you, and it didn’t.

 

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FDA Announces that Permanent Peripheral Neuropathy is to be Added to Warning Labels for Fluoroquinolone Antibiotics

 Essay #1

On August 15, 2013 the FDA announced that a new, highlighted warning would be added to all orally administered and injected fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, etc.), noting that these drugs cause peripheral neuropathy.  The announcement can be viewed through this link – http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm The Related Information links give further details on the dangers of fluoroquinolones and the rationale behind the FDA’s decision to finally, after 30 years of consumer complaints, to warn people of this devastating effect of fluoroquinolones.

The FDA announcement is a HUGE step in the right direction. Now, when patients go to their doctors with sudden, severe pain in their extremities, their doctors are going to be more likely to connect the patient’s peripheral neuropathy with the fluoroquinolone antibiotic that the patient took.  As more and more doctors make the connection between their patients’ painful, burning, swollen feet (among other symptoms of peripheral neuropathy) and fluoroquinolones (again, Cipro, Levaquin, Avelox, etc.), they will be more likely to recognize the severity and frequency of adverse reactions to these drugs.  They may even start connecting the other symptoms that their patients experience with fluoroquinolones and really, truly acknowledging the damage that these drugs do.  This recognition may/should/will start the ball rolling in the direction of doctors actually using fluoroquinolones appropriately – as a drug of last resort, to be used only in life-or-death situations.

At the very least, this new warning increases the likelihood of a correct diagnosis from a doctor for those who are suffering from Fluoroquinolone Toxicity Syndrome.  When I went to my doctor with swollen, painful, weak hands and feet (and hives all over my body), she told me that it wasn’t possible that my issues were from the Cipro that I had taken 2 weeks earlier.  She was wrong.  Now that this warning label has been added, it is less likely that she’ll misdiagnose the next patient who comes to her with similar symptoms.  She is more likely to realize that Cipro, Levaquin, Avelox and other fluoroquinolones are dangerous drugs with severe consequences to the health of her patients.

The doctors who connect the peripheral neuropathy that their patients experience with  fluoroquinolones will be more likely to report the adverse reaction to the FDA.  As more and more reports of adverse effects of fluoroquinolones are reported, it is more likely that the real risks of these drugs are properly established, by the FDA and physicians alike.  Once risk is properly established, a more reasonable protocol for their use can be established.

As someone who has suffered through Fluoroquinolone Toxicity Syndrome and peripheral neuropathy caused by Cipro (taken to treat a simple UTI), I’m thankful for the FDA’s acknowledgment of the peripheral neuropathy that people experience as a result of fluoroquinolones.  Really, I’m grateful for the move in the right direction.  But there are some things that bother me about the announcement.

First, they state that, “The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.”  Really, FDA?  You think that these drugs applied in the ears and eyes don’t have devastating system-wide effects?  Fluoroquinolone ear and eye drops are typically in low enough doses that Flouroquinolone Toxicity Syndrome doesn’t result, but don’t you still think that the people who take the ear and eye drops (or administer them to their children) should at least know that these drugs cause permanent peripheral neuropathy when administered in another form?  It seems appropriate to at least make some sort of note about this serious side-effect, especially when these drugs are given to children to treat ear infections.  The specialist model of the Western medical system that treats each part of a body as separate and as if it doesn’t connect with the rest of the body, is absurd.  If a drug is dangerous when administered orally, it’s pretty likely to be dangerous when put into the eye.  It just seems negligent to not warn people of the adverse effects of a drug in all forms in which they’re available.

Second, they state that, “If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.”  Well, at least the standard instruction of “finish the entire course of antibiotics” is abandoned.  Instructing people to finish a course of a drug that they’re having a severe adverse reaction to is bad advice, to say the least – and it was standard protocol for years.  But there is the implication that if the patient stops taking the fluoroquinolone, the ceasing of taking the drug will help to stop the reaction that is causing the peripheral neuropathy.  Unfortunately, this isn’t the case.  At least the FDA mentioned that the peripheral neuropathy can be permanent, so the fact that it won’t be fixed by cessation of taking the drug is at least acknowledged.

The warning of peripheral neuropathy is the third highlighted warning on fluroquinolones.  The other two are for death in those with myasthenia gravis and tendon ruptures (for everyone, not just those with  myasthenia gravis).  Now that peripheral neuropthy is added to the list of side-effects that are severe enough to require a highlighted warning, maybe people will start realizing that these are dangerous drugs, and maybe doctors will start following their Hippocratic Oath and stop prescribing them in cases where other, safer antibiotics can get rid of the infection just as well.

Essay #2

On August 15, 2013 the FDA announced that a new warning label is to be added to all orally administered and injected (via IV) fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, etc.) warning people of the serious side-effect of peripheral neuropathy.  The FDA announcement notes that peripheral neuropathy is serious nerve damage and that it can be permanent.

http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm

As someone who took Cipro and subsequently experienced painful peripheral neuropathy, I’ve got to say that this validation from the FDA feels pretty darn good.

As most sensible people would, I went to my doctor when I broke out in hives all over my body, my hands and feet were swollen and painful, my tendons throughout my body were tight and my legs were so weak that I could barely stand.  I was told that they didn’t know what was wrong with me.  As far as missed diagnosis’ go, “I don’t know” is a pretty benign one, so I’m thankful for it.  I could have been incorrectly told that I had Rheumatoid Arthritis or a number of other diseases that my symptoms mimicked (M.S., Lupus, Fibromyalgia, Lyme Disease, Chronic Fatigue Syndrome, Leaky Gut Syndrome, etc.).  When I asked my doctor if it was possible that the Cipro that I had taken prior to the emergence of my symptoms, she told me that it wasn’t possible.

It’s not only possible, it’s true.  The FDA announcement confirms what I already know to be true – Cipro caused my peripheral neuropathy (and all my other health problems, but the FDA hasn’t confirmed that yet).

VINDICATED!  After 20 months of health issues caused by Cipro, an ANTIBIOTIC I took to treat a simple urinary tract infection, the FDA finally confirmed that the peripheral nerve damage that I suffered from was caused by the pharmaceutical I took, the so-called medicine.

Perhaps someday the FDA will put a highlighted warning on fluoroquinolone antibiotics about the CNS damage that they can cause.  Yup, CNS damage.  That’s brain damage, folks.  A petition is circulating to get a warning of the risk of CNS damage added to the labels of all fluoroquinolones.  Please sign it – http://www.change.org/petitions/food-and-drug-administration-department-of-health-and-human-services-black-box-warning-for-fq-drugsand-cns-damage  People deserve to KNOW about the devastating, sometimes permanent, adverse effects of these drugs.

There are now three highlighted warnings on the labels for fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, etc.)  One warning of increased risk of developing tendonitis and TENDON RUPTURE, another warning of DEATH in patients with myasthenia gravis, and now another warning for possible permanent PERIPHERAL NEUROPATHY.  Additionally, the FDA is being petitioned by consumers who have suffered from brain damage to add CNS damage to the list of warnings.

Do ya think that there may be a problem with these drugs?

Yes, there’s a problem with these drugs!  And given the rampant use of them, 26.9 million people were either given fluoroquinolone pills or IVs in 2011 (per the FDA) and the rate of adverse reactions ranges from 4.4% to 20% (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/?report=printable), it’s a BIG problem!  Do the math, you’ll find that one to five million people were adversely effected by these drugs in 2011 alone.  Adverse reactions can range from an annoying but harmless eyelid twitch to body-wide breakdown and PERMANENT PERIPHERAL NEUROPATHY, TENDON RUPTURE and even DEATH.

Serious policy changes need to be enacted around these drugs.  They can sometimes be necessary to save a life and therefore they shouldn’t be banned.  But maiming and disabling people with a class of antibiotics when there are other, safer antibiotics available, is ABSURD and it’s WRONG.

The new warning is a good start, but we need you to keep going, FDA.  Do what should have been done years ago.  The research is out there.  Pay attention and do what’s right.  Please.

A song – 

 

 

Ciprodex – Poison Marketed to Children

Ciprodex Ear Drops

Ciprodex is an ear drop that is used in children, especially children under the age of 3, the main people who get ear infections, that contains Cipro, a fluoroquinolone antibiotic, and Dexamethasone, a steroid. Let me list the ways in which this is HORRIFYING:

  1. Fluoroquinolones are dangerous drugs. Their adverse effects include DESTRUCTION of all connective tissue throughout the body. This includes tendons, ligaments, fascia and cartilage. Destroying the connective tissue of a growing child is a REALLY BAD IDEA. Fluoroquinolones also adversely effect the nervous systems – central, peripheral, and autonomic nervous systems. Destroying a child’s central nervous system, its BRAIN, is also a REALLY BAD IDEA. A child’s brain is not fully developed and to damage it with chemicals is unconscionable. Fluoroquinolones are so dangerous that many have been removed from the market due to serious adverse reactions and safety concerns. The fluoroquinolones that have been removed from the market include gatifloxacin, repafloxacin, temafloxacin,trovafloxacin and afloxacin. Cipro (ciprofloxacin) may be formulated in a way that makes it slightly less strong, or, if you’re feeling cynical, it may be formulated in a way that adverse effects tend to be delayed, and thus it is not perceived as being as dangerous as other, recalled, fluoroquinolones, but it’s still REALLY DANGEROUS. Hell, it messed me up pretty severely, and I was a strong and healthy 32 year old. I can only imagine what it would do to a child. I shudder at the thought.
  2. Fluoroquinolones should NEVER be co-administered with a steroid. They are contraindicated with steriods. Yet Bayer, in all its glory and brilliance, decided that it would be a good idea to combine a fluoroquinolone and a steroid in a single medication then market it to children. Awesome. Steroids weaken tendons, fluoroquinolones weaken tendons, putting them together is a toxic cocktail. Steroids also intensify the toxicity syndrome that is “Floxing.”
  3. Because Ciprodex is an ear drop, it doesn’t carry the same warnings as orally administered Cipro. I’m sure that a drug that goes into the digestive tract is metabolized differently than a drug that goes into the body via the ear. However, I am also sure that people can be floxed by ear and eye drops because I’ve talked to people who have been poisoned that way. To take the warning labels off of ear and eye drops is absurd. The drugs are still going into the body. Eyes and ears aren’t disconnected from the rest of the body just because they’re not directly connected to the digestive tract. I’m not asking anyone to believe in homeopathy or to go to a holistic physician, but I am saying that it is crazy to think that drugs that go into the ear and/or the eye don’t go into the body. Ears and eyes actually are part of the body, not separate floating entities completely disconnected from the rest of the being. Yet the FDA treats them this way and doesn’t demand the same warning labels on ear and eye drops. So parents are completely uninformed of the dangers of Ciprodex when they administer it to their children.
  4. Again Ciprodex is specifically marketed to children – what is wrong with these people? And what is wrong with the FDA? Children, the most inherently vulnerable people in our society, the people who are depending completely on others to take care of them, are being endangered at the least and permanently damaged at the worst, by pharmaceutical companies and a medical system that isn’t looking out for them. This is disgusting.

Here is the package insert for Ciprodex – http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0ed518de-4ae1-43d1-84ff-26872d9e6a0f . Some things to note in the insert are:

  1. The amount of Cipro in it is low. This is good. Seriously, thank God.
  2. It is approved for use in patients 6 months of age and older. This is appalling.
  3. CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.” So, if your baby starts having seizures, you may want to discontinue use of this drug because it turns out that your child now has a history of hypersensitivity to Cipro. Too bad they don’t mention that an adverse reaction isn’t reversible. And how, other than poisoning their children, are parents supposed to know whether or not their child has a history of hypersensitivity to these drugs?
  4. Serious acute hypersensitivity reactions may require immediate emergency treatment.” This implies that there is a treatment. There isn’t. If your child has an adverse reaction to this drug and you take him or her to the emergency room, he or she will likely be pumped full of steroids which will make him or her worse. Then the child will have connective tissue and nervous system issues for a while, possibly for the rest of his or her life. But sure, tell your doctor immediately if your child experiences a hypersensitive reaction. They won’t be able to do anything about it, but they may realize that they poisoned your child and may avoid doing it again in the future.
  5. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment.” Cultures should be obtained before the administration of any antibiotic, period. Fluoroquinolones should not be used as a first line of defense against verified bacteria, period.
  6. The systemic administration of quinolones, including ciprofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.” Yup. And I wouldn’t trust that the amount absorbed by the otic route is too small, especially seeing as everyone’s tolerance for fluoroquinolones seems to be different. Some people die after 2 pills, others take 90 before they have a reaction. Besides, the people who are testing these drugs are the ones selling them. Don’t trust the bastards.
  7. Guinea pigs dosed in the middle ear with CIPRODEX® Otic for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles.” Well, it’s nice to know that their ears looked okay. Could they run though? Could they still find their way through a puzzle (or do whatever cognitive things guinea pigs can do?) How did their brains look? How did their tendons look? You don’t know because you weren’t looking? Oh…. I see.
  8. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve.” It is very important to stop using fluoroquinolones as soon as possible after you start having an adverse reaction. Even after stopping administration of them, the adverse reaction can continue. Since we’re talking about children, it’s really important that you stop giving your children drugs that are poisoning them. Discontinue use immediately.
  9. Specific drug interaction studies have not been conducted with CIPRODEX® Otic.” I’ll tell you that NSAIDs and steroids trigger adverse reactions.
  10. Ciprofloxacin and corticosteroids, as a class, appear in (breast) milk following oral administration.” This is bad.
  11. No clinically relevant changes in hearing function were observed in 69 pediatric patients (age 4 to 12 years) treated with CIPRODEX® Otic and tested for audiometric parameters.” Your child will still be able to hear. That’s good. He or she may even be able to hear constant ringing (tinnitus), a common effect of fluoroquinolone toxicity. That’s bad.
  12. All of the adverse events listed are things involving the ear. Of course, adverse effects on the ear should be noted when studying ear drops, but the rest of the subject should also be noted. Of the 937 babies poisoned by Ciprodex, how many suffered from subsequent tendon pain? How many had cartilage, tendons, ligaments or fascia that were mal-formed? How many of these children subsequently read at a normal level? How many of these children displayed symptoms of autism? Could they run? Could the jump? Could they think? Could they concentrate? Did they have GI problems? ALL of these things are problems associated with fluoroquinolone toxicity, and if none of these questions were asked, then the researchers were LOOKING AT THE WRONG THINGS. THEY WERE ASKING THE WRONG QUESTIONS AND THE SAFETY AND EFFICACY OF THIS DRUG HAS NOT BEEN ESTABLISHED PROPERLY.

Even if all of the 937 children who were part of this study (side-note – don’t put your children in drug studies, just don’t) were fine, (and I doubt that is the case), effects of fluoroquinolones appear to be cumulative. So, even if these children didn’t react to these drugs the first time they were administered, they may react horribly to them when they get a fluoroquinolone in the future. A ticking time-bomb in their little body has been triggered, and it may get set off by future fluoroquinolone use, steroid use, NSAID use, or maybe even vaccines. (I’m not trying to vilify vaccines any more than I’m trying to vilify ibuprofen, the culprit is the fluoroquinolone, not the triggering toxin.)

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Ciprodex and plain Cipro ear drops are given to children constantly. A very good friend of mine brought her then 9-month old daughter to an emergency services clinic with a suspected ear infection. The doctor never cultured the bacteria in her ear, he simply prescribed her some Cipro ear drops. Thankfully I was with my friend when she went to pick up the drops and she never filled the prescription (because I flipped out). The infection went away on its own.

The following was recently posted in a Facebook group that I belong to – “My 20 month old grandson is visiting from GA. He had a follow-up appointment at Vanderbilt for his ear tubes. The physician prescribed Ciprodex Otic Suspension for an ear infection. This is a combination of Cipro and corticosterod given via the ear. The insert does not disclose all the potential side effects. The insert states there are other potential risk and if you have concerns get additional information from your health care provider (which we know how that goes). After watching my wife go from a normal life to a life with disabilities…..I am concerned. In my personal research, children are at high risk of floxing. Does anyone know of floxing via the ear drop forms of quinolone antibiotics?”

Children are being given this poison every day. A child has probably been given a dose of Ciprodex in the amount of time that it took you to read this post. I hope and pray that they are okay.  

 

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