Tag Archives: dangerous drugs

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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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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Letter to Congress Re the 21st Century Cures Act

The 21st Century Cures Act is going through the Energy & Commerce Committee now. You can read more about the Act here – http://energycommerce.house.gov/cures. The 21st Century Cures Act is a thinly veiled corporate give-away for the pharmaceutical companies. There are many things that I object to in the Act, but I think that its momentum is unstoppable so I’m recommending changes to it, rather than killing it. I am going to send the following letter to the bill’s sponsors, Fred Upton and Diana DeGette. I will also send this letter to my Congressional representatives. I encourage everyone reading this to send a letter to Congressman Upton, Congresswoman DeGette and other Congressional representatives. Please feel free to use my letter as a template, or to customize it as you see fit.

Also, please “tweet” your letters, stories, and anything else that you want to say about the 21st Century Cures Act to the Energy & Commerce Committee @HouseCommerce, Representative Upton @RepFredUpton, Representative DeGette @RepDianaDeGette and use the hashtags #Cures2015 and #Path2Cures. Thanks!

May 16, 2015

Re: Inclusion of Consumer Protection against Adverse Drug Reactions in the 21st Century Cures Act

Dear Chairman Upton and Representative DeGette:

I am writing because I have suffered from an adverse reaction to a popular pharmaceutical, and I would like to see more consumer protection and safety measures added to the 21st Century Cures Act.

At the age of 32, I went from doing crossfit regularly to barely being able to walk because I suffered from an adverse reaction to ciprofloxacin, a powerful fluoroquinolone antibiotic that can permanently damage all the nerves and connective tissues in one’s body. In addition to loss of mobility, I suffered from memory loss, loss of reading comprehension, loss of energy, and pain. There are many people who have significantly worse reactions than I did.

Because adverse reactions to fluoroquinolone antibiotics (and other pharmaceuticals) can be delayed, they are bizarre in nature (who would think that a prescription antibiotic could cause multi-symptom, chronic illness that resembles an autoimmune disease?), and adverse reactions can occur after previously tolerating the drug well, they are thought to be “rare.” I would argue that they are actually under-recognized.

However, since The 21st Century Cures Act focuses on “rare” conditions, I encourage you to focus some attention in the bill to “rare” adverse reactions to prescription drugs.

When people are hurt by a prescription drug they are often unable to gain help from the medical establishment (doctors can’t put your cells back together – the tv ads are misleading), and they are often unable to gain justice through the legal system (if a devastating adverse effect is listed on the warning label, you cannot sue because “you were warned”).

The pharmaceutical companies need to take more responsibility for the damage that the drugs that they create and manufacture do. Warning labels are not enough. They simply shift the blame from the maker of the drug to the victim of the drug. Enclosed is a plan to make pharmaceutical companies take responsibility for the harm done by the drugs that they discover, produce and put into the market.

The 21st Century Cures Act is proposing to get rid of many safeguards that are currently in place that keep dangerous drugs from entering the market. This is the wrong thing to do. More consumer safeguards need to be put in place, not fewer. If you are going to get rid of phase III clinical trials for potentially dangerous drugs, there MUST be systems in place to gather information about adverse reactions that occur in the general public that is consuming the drugs. I encourage you to put systems in place that require long-term and intergenerational studies to be performed on all drugs that are on the market.

The 21st Century Cures Act has a section that focuses on encouraging the development of new antibiotics. While it should be acknowledged that antibiotic resistance is a problem, the solution should be focused on prudent use of antibiotics, not the development of stronger antibiotics. Antibiotic drugs are not benign. I was hurt by an antibiotic drug—ciprofloxacin. It caused a multi-symptom syndrome that looked and felt like an autoimmune disease. Fluoroquinolone antibiotics have been found to have deleterious effects on mitochondria, neurotransmitters, the microbiome, the endocrine system, and more. Long-term studies to see if they are causally related to the many chronic diseases of modernity that are affected by mitochondria, neurotransmitter, microbiome and hormonal health, have not been conducted. Long-term studies on dangerous drugs like fluoroquinolones, that work by disrupting the DNA and RNA replication process for bacteria and mitochondria, should be conducted before the production of more drugs in their class is encouraged.

More attention should be paid to causes of the chronic diseases that plague our society. A major cause of chronic disease is ongoing cellular damage caused by pharmaceuticals.

Please balance out the 21st Century Cures Initiative so that it takes into consideration that pharmaceuticals are inherently dangerous and have multiple, often unacceptable, adverse effects. Moves toward greater drug safety are necessary and appropriate.

Thank you,

Lisa Bloomquist

Lakewood, Colorado

Enclosed: “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” by JMR on http://fluoroquinolonethyroid.com/

 

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Fluoroquinolone Antibiotic Dangers: Why Didn’t They Tell Me??

GABA receptors and fluoroquinolones

Copyright 2009 Pharmacology Weekly, Inc. Printed with Permission.

There are hundreds of peer-reviewed research articles about how harmful fluoroquinolones are.

The harm done by these dangerous drugs hasn’t been communicated to patients or medical professionals though.

Here are a few things your doctor should have told you about fluoroquinolones before she or he prescribed them to you:

FLUOROQUINOLONE ANTIBIOTIC DANGERS: WHY DIDN’T THEY TELL ME?

Thank you for reading and sharing!

 

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Adverse Drug Reactions are Like Earthquakes

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Here is a post about how adverse drug reactions are like Earthquakes –

http://www.hormonesmatter.com/adverse-drug-reactions-like-earthquakes/

Drugs, just like earthquakes, can shake your world and cause damage and destruction.

 

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