Tag Archives: warning labels

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!

*****

EMA Final Decision re Fluoroquinolones

The European Medicines Agency (EMA) released their final decision regarding fluoroquinolones. You can read the EMA verdict in “Quinolone- and fluoroquinolone-containing medicinal products” and “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” (both from the EMA web site). Additional information can be found on the UK Government web site in the article, “Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects.” Changes to European fluoroquinolone labels can be viewed HERE.

From the EMA:

Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

Please excuse me for not knowing exactly how European drug regulation works (and please correct me if I am wrong), but it looks like the EMA makes recommendations, then the various European governments pass down instructions to their citizens.

The UK government web site gave the following recommendations to healthcare providers:

Advice for healthcare professionals:

  • systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
  • advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice – sheet for patients

do not prescribe fluoroquinolones:

  • for non-severe or self-limiting infections, or non-bacterial conditions

  • for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate (see below)

  • ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic

  • prescribe with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury avoid use of a corticosteroid with a fluoroquinolone since co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

  • report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store)

I hate that they put “very rarely” into these warnings, seeing as adverse reactions to fluoroquinolones are woefully under-studied and the assertion that these effects are “rare” is based on assumption rather than fact. BUT, these prescriber guidelines, along with the EMA guidelines, are steps in the right direction, and hopefully they will cut unnecessary fluoroquinolone prescriptions significantly.

Here are a few notes about the proposed changes to the European Fluoroquinolone Warning Labels:

  1. It is recommended that fluoroquinolone use be restricted for uncomplicated cystitis, Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease, Acute bacterial rhinosinusitis, and Otitis media acute.
  2. The warning labels are still leaving a lot of discretion to doctors/prescribers, and state, “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.” even though other parts of the warning label note that FQs should not be used for that particular indication. I worry that this may lead to some confusion among doctors/prescribers.
  3. The new warning label notes that people who have experienced adverse reactions to fluoroquinolones in the past should not take fluoroquinolones. “The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with [INN] should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.”
  4. The possibility of prolonged, serious, and disabling side effects of fluoroquinolones are noted. “Prolonged, disabling and potentially irreversible serious adverse drug reactions
    Very rare cases of prolonged (continuing months or years), disabling and potentially
    irreversible serious adverse drug reactions affecting different, sometimes multiple, body
    systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients
    receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk
    factors. [INN] should be discontinued immediately at the first signs or symptoms of any
    serious adverse reaction and patients should be advised to contact their prescriber for
    advice.”
  5. I’m slightly shocked that the risk of tendon problems is just-now being added to European warning labels, but it is one of the changes noted. “Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.”
  6. Warnings about peripheral neuropathy are also added. “Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.”
  7. Permanently disabling effects are noted again, “*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors.”
  8. Disappointingly, the “Package leaflet: Information for the patient” is full of the words “very rarely” when referring to all the potential effects of fluoroquinolones. Again, the exact rate of adverse reactions to fluoroquinolones is unknown (and may be unknowable because of delayed adverse reactions), and I think that it’s a dis-service to patients to downplay the possibility of these serious and severe effects of fluoroquinolones.

THANK YOU, THANK YOU, THANK YOU to all the European advocates that pushed for these changes in fluoroquinolone warnings and prescribing. You have made an enormous difference, and hopefully rates of fluoroquinolone prescriptions will decrease significantly because of your advocacy.

*****

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

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.

 

 

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.

 

 

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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