Tag Archives: effects of cipro

FDA Gives Up on Meaningful Patient Safety Measures, Instead Changes Warning Labels

 

A friend* forwarded me a few pharmaceutical industry articles about the November, 2015 FDA hearing regarding fluoroquinolone safety and labeling. The articles are interesting because they show the pharmaceutical industry perspective on the hearing and fluoroquinolones. They are also valuable to us as patient and drug-safety advocates because they are difficult to access—The Pink Sheet articles are typically behind a $1,000+ paywall, and neither The Pink Sheet nor The RPM Report are easily accessible by the public.

The Pink Sheet article was surprisingly balanced and thoughtful, while the RPM Report article was dismissive of patient pain (attributing patient symptoms to social media bandwagoning is a bit…. dickish). However, both articles acknowledge that the patient testimony provided at the November, 2015 FDA meeting was moving, and that people described serious and severe adverse-reactions to fluoroquinolones. It also seems that the pharmaceutical industry is somewhere between resigned-to and supportive-of the updated warning labels on fluoroquinolones. Perhaps I’m reading things into the articles that aren’t entirely there, but they seem to be a bit perplexed as to what to do about Fluoroquinolone Associated Disability–FQAD–which is mentioned by name in both articles, despite it not being an official and recognized label.

Interestingly, the pharma articles bring up a few things that I wholeheartedly support (that they don’t necessarily support, they just mention these things). Before I go into the programs that I support (that are actually brought up in the pharma articles because they aren’t happening, not because they are), I think that we should examine the pharma reaction to the updated warning labels. Why might pharma not continue to fight the updated warning labels?

Perhaps because they know that updated warning labels will not significantly impact fluoroquinolone prescription rates, or their profits.

During the FDA hearing, the pharmaceutical industry fought the updated warning labels on fluoroquinolones, but, as I described in THIS POST, they didn’t fight the updated warning labels because severe/accurate warning labels change prescribing behaviors or cut into their profits, they opposed the warning label updates because warning label updates open the door for patients to sue the pharmaceutical companies for harm caused by their products. Other than that, warning label changes don’t do much at all.

I’m proud of the fluoroquinolone-injured community for all the advocacy and work that went into getting the November, 2015 FDA hearing, and updated warning labels. Those things are accomplishments that should be celebrated. But we should also ask the questions—will those updated warnings actually make a difference? Will doctors stop prescribing Cipro, Levaquin, Avelox, Floxin, and their generic equivalents, for treatment of uncomplicated urinary tract infections (or cystitis), sinusitis, and chronic bronchitis? Will patients and physicians recognize that fluoroquinolones can cause disabling and potentially irreversible serious adverse reactions? The black-box warning notes these things, but will people actually read the updated warning labels and change their actions accordingly?

I hate to say it, but I suspect that the answers to the questions above is no. I think that pharma is resigned to updated warning label as a risk mitigation strategy. They understand that there needed to be a response to the heart-wrenching testimony provided by people whose lives have been devastated by fluoroquinolones, and that the rate of permanent disability resulting from fluoroquinolones reported in the FDA adverse events reporting system (FAERS) is entirely unacceptable, so they went along with a “solution” that they hoped would appease those who have been hurt by fluoroquinolones—an updated warning label.

They know though, that an updated warning label won’t dramatically change how fluoroquinolones are thought of or prescribed. The earlier warning labels were already significant, and though the acknowledgment that comes with seeing, “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,” is important, what really matters is changing the way that fluoroquinolones are prescribed so that people aren’t unnecessarily hurt by dangerous, disabling pharmaceutical drugs.

The RPM Report notes how the conversation shifted, in the FDA meeting, from concern for those harmed to concern about “communicating risks”:

“DSaRM committee member Tobias Gerhard (Rutgers) said that the evidence from FAERS is not supported yet by epidemiological data but that the distinction of whether it’s a syndrome or not is ‘somewhat secondary’ to communicating risks to separate disabling effects and future work can assess whether there is a syndrome.”

Mr. Gerhard is wrong. The problem isn’t that people aren’t being warned sufficiently, The problem is that PEOPLE ARE BECOMING DISABLED BY FLUOROQUINOLONES AND THAT FLUOROQUINOLONE ADVERSE-REACTIONS MANIFEST AS A SYNDROME. Both the FDA, and the pharmaceutical industry, seem to think that the problem is a lack of awareness, and that updating fluoroquinolone warning labels will solve the problems that FQAD patient advocates are advocating for.

I think it will behove us, as drug-safety advocates, to recognize that this is what they’re doing. They shift the conversation from harm-caused to risks-communicated. They seem to think that it’s okay for an an antibiotic to cause permanent harm and disability as long as people were warned. They can shift the responsibility from the drug-manufacturers, who should be held responsible for the harm their product causes, to the consumer, who they claim “was warned.”

This happens with many dangerous drugs and medical devices, not just fluoroquinolones. The FDA and Bayer responded to patients screaming about how Essure, a permanent contraceptive device, had caused pain and disability to thousands of women, by putting a black box warning on Essure. They didn’t do anything meaningful—like discontinuing Essure because there are safer forms of permanent contraception—they just adjusted the warning label.

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Is the FDA so weak that they are incapable of forcing pharmaceutical companies to take responsibility for the dangerous products they create? Apparently. Their inability to take responsibility for the dangerous drugs they peddle means that consumers, you and me, must beware, because we’re taking dangerous drugs at our own risk.

They’ll pretend to actually “do something” by having meetings, hearings, and changing the warning labels. They know that those things won’t actually keep people from getting hurt by dangerous drugs though.

However, the Pink Sheet and The RPM Report articles note that there are a few meaningful things that can be done to change how fluoroquinolones are thought of and prescribed. They mention these things not as suggestions, but rather as a note of things that are not occurring. The Pink Sheet article points out that the FDA failed to call for a Risk Evaluation and Mitigation Strategy (REMS) for fluoroquinolones after the November, 2015 meeting, and the RPM Report points out that no epidemiological studies have been done for fluoroquinolones. Both a REMS and a thorough and well-funded epidemiological study of fluoroquinolones would be real, meaningful steps toward patient safety and quantifying the damage done by fluoroquinolones.

REMS are “required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks.” FDA published overviews of REMS can be found HERE.

Per the FDA, “FDA can require a REMS if the agency determines that safety measures are needed beyond the professional labeling to ensure that a drug’s benefits outweigh its risks,” and, “If FDA becomes aware of new safety information* (*New safety information is defined as a serious risk associated with use of the drug which FDA has become aware since the drug was approved, since a REMS was required, or since the last assessment of the REMS) and determines REMS is necessary to ensure that the benefits of the drug outweigh the risks.”

A REMS could, for example, do the following (and more):

  • Require a positive and responsive bacterial culture prior to the prescription of any fluoroquinolone.
  • Require that other antibiotics be tried, and/or ruled out, before a fluoroquinolone is prescribed.
  • Require that medical providers go over the black-box, and other warnings and precautions, with patients prior to prescribing and administering fluoroquinolones. (It would be nice if things like delayed adverse reactions, tolerance thresholds, and the fact that there is no cure for FQAD, were included in the review as well.)
  • Require that liver function tests be performed prior to prescribing or administering fluoroquinolones. (We are a ways off from knowing exactly what liver tests may be predictive of adverse reactions to fluoroquinolones.)
  • Require genetic tests for MTHFR and other mutations prior to prescribing or administering fluoroquinolones. (We are a ways off from knowing what genes predispose people to adverse reactions to fluoroquinolones.)
  • Require that additional warnings and education be provided to patients in high-risk categories such as those with a history of autoimmune disease, neurodegenerative disease, psychiatric illness, athletes, children, etc. (Studies need to be done to determine exactly who is at higher risk of fluoroquinolone adverse reaction.)
  • Initiate a campaign of “Dear Healthcare Provider” letters to educate healthcare providers about the risks associated with fluoroquinolones.
  • A REMS could also start a database to help track fluoroquinolone recipients, as well as their adverse-reactions.

All of those would be substantial steps toward minimizing inappropriate fluoroquinolone prescriptions, and reducing the number of people suffering from serious adverse-reactions.

However, the FDA decided not to require a REMS. Instead, they adjusted the warning labels.

The Pink Sheet states:

The decision not to require a REMS to address the risk of disabling side effects with the antimicrobials (fluoroquinolones) could reflect agency wariness about potentially cumbersome risk management programs for the widely prescribed drugs, particularly given its recent experience with REMS for the long-acting/extended-release opioid products.”

The REMS for long-acting/extended-release opioids involved voluntary education for healthcare providers, and “a recent advisory committee review of the REMS showed the number of prescribers completing the training was far below the target goal.”

So, because the REMS for an entirely different class of drugs–long-acting/extended-release opioids–failed, we don’t get a REMS for fluoroquinolones.

A REMS that was similar to the REMS for long-acting/extended-release opioids, that only involved voluntary education for healthcare providers, would be too weak to make much of a difference anyhow, in my opinion. Yes, doctors need to hear about the serious, severe, disabling, and deadly adverse-effects of fluoroquinolones, but without any restrictive prescribing guidelines, that knowledge wouldn’t actually keep many patients from getting hurt by fluoroquinolones.

The Pink Sheet notes:

Given lingering questions about the effectiveness of the ER/LA opioids REMS – at least in the eyes of the FDA and its external advisors – the agency may be more inclined to try to reduce the risks of fluoroquinolone use through labeling changes rather than imposing another complicated risk management program.”

It sounds to me like the FDA has given up on using REMS as a tool. They’ve given up on a tool that could meaningfully improve patient safety. Now the FDA just changes warning labels and tell patients “you were warned” when they suffer from severe adverse drug reactions. They know that’s not actually doing anything to make patients safer, right? They know that they have tools at their disposal that could make patients safer, right? They’re just choosing not to use those tools. They have given up on meaningful patient safety regulation. It’s sad, really.

Perhaps epidemiological studies are needed in order for the FDA, pharma, and healthcare providers to understand the real and serious effects of fluoroquinolones, and after they get some epidemiological study results they will order a thorough REMS (we can always hope). However, it should be noted that no epidemiological studies have been performed examining fluoroquinolones as they relate to chronic disease or disability.

The RPM Report article states that there have not been epidemiological investigations of fluoroquinolone associated disability – “FDA Division of Epidemiology II Director Judy Staffa said they agency has not found any epidemiological investigations of the syndrome,” and:

“Many FQAD events are not hospitalized and it is not clear what codes may be used; patients also often have symptoms from multiple body systems so may see many different physicians. She (Debra Boxwell of the FDA’s Division of Pharmacovigilance) said there are challenges and expenses with trying to get medical charts for validation, acknowledging that there would ‘certainly be a lot of prescriptions of fluoroquinolones in the system.'”

Yes, there certainly are challenges with performing epidemiological studies of fluoroquinolones and their effects. The delayed adverse reactions, tolerance thresholds, and diffuse and bizarre nature of the adverse-effects make epidemiological studies difficult to perform. But the difficulty in performing adequate and informative epidemiological studies doesn’t mean that they shouldn’t be performed, or that information potentially gleaned from an epidemiological examination of FQAD wouldn’t be something on which policy-changes could be based.

The post, Dear Epidemiologists, Consider Fluoroquinolones, and its introduction on this site, go over some suggestions for epidemiologists who are willing to look into FQAD, and the potential relationship between fluoroquinolones and the various diseases of modernity that fluoroquinolone toxicity symptoms resemble. I hope that the FDA, or some other institution, will perform a well-designed epidemiological study that examines whether or not there are significant links between fluoroquinolones and other disabling syndromes such as autoimmune diseases, “mysterious” diseases like fibromyalgia and ME/CFS, psychiatric illnesses, diabetes, and more.

The only studies that I know of that are examining FQAD are the UCSD Fluoroquinolone Effects Study, and the Lucine Health/Hormones Matter Fluoroquinolone Antibiotic Side Effects Survey, and I do not know if either one is receiving funding from, or corroborating with, the FDA. From what I know about these studies, they will document the severe and disabling effects of fluoroquinolones, but I am not sure whether or not they will examine links between fluoroquinolone use and other disabling, chronic diseases. Epidemiological studies that quantify the extent and severity of fluoroquinolone associated disability still need to be conducted.

Both epidemiological studies, and a REMS, should be performed in order to assess fluoroquinolone safety. According to The RPM Report:

there are about 32-33 million retail prescriptions annually for quinolones, with about two thirds for ciprofloxacin. Levofloxacin generates about 10 million annually. The other drugs are now very rarely prescribed.”

Yet we have no real notion of how many people are being hurt and disabled by fluoroquinolones because no epidemiological studies have been done. Healthcare providers have no notion of what procedures and precautions take when prescribing fluoroquinolones because there is no REMS to provide guidance. Fluoroquinolones are dangerous, and sometimes disabling, drugs. Yet, rather than doing something meaningful to quantify or mitigate the risk of fluoroquinolone adverse-reactions, the FDA has chosen to simply increase the size and content of the warning labels for Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and other fluoroquinolones. The FDA seems to think that risk-communication is the problem, but it’s not—the problem is that fluoroquinolones are dangerous, disabling drugs, and that nothing is being done to quantify or address those risks.

Interestingly, pharma seems to know that the proper thing to do is to quantify the risks posed by fluoroquinolones in epidemiological studies, and to mitigate their risks with a REMS. They wouldn’t have mentioned those approaches in their industry publications if they didn’t think that epidemiological studies and a REMS were appropriate measures for the FDA to take.

The FDA didn’t take the opportunity to order an epidemiological study, or a REMS, at the November, 2015 meeting though. Instead, they changed the fluoroquinolone warning labels. It’s what they do now. They’re publishers, not regulators or patient-protectors.

Even pharma seems surprised at their ineptitude.

* The friend who sent me the Pink Sheet and RPM Report articles is Nick Newell. When I asked him if I should use his name he said, “I think there’s already too much secrecy and anonymity around questions of drug safety – that’s part of the problem. So if you do post it, please feel free to use my name.” Nick lost his brother Oliver to fluoroquinolone toxicity. You can read the Newell family tribute to Oliver and description of fluoroquinolone adverse reactions HERE. Nick and his sister are featured in the news story that can be viewed below, and his testimony at the 11/15 FDA hearing can be read starting on p. 275 of this transcript. He is an advocate and a friend, and he is greatly appreciated.

Floxie Twilight Zone

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Kristin Weber put her story of fluoroquinolone toxicity on Hormones Matter.  I encourage you all to read it:

FLUOROQUINOLONE POISONING: A TALE FROM THE TWILIGHT ZONE

It is beautiful, thoughtful, poignant, honest and heart-wrenching.

Here are some of my favorite quotes from it (all are direct quotes, re-printed with the author’s permission).  She writes beautifully and I get shivers reading her story.

“Now imagine spending three entire years dealing with this, suffering in ways you never imagined possible, every day bringing a new version of misery. Some days you can’t walk without pain. Some days your hands and feet burn all day. Some days a migraine slurs your speech, and makes you feel cross-eyed with distorted limbs, and joints twisted up like a pretzel. Some days you feel electrocuted; other days fatigue leaves you with leaden limbs, a supreme effort required for every move. Some days you’ll experience all of the above, and then some.”

“Your small child will grow into a young adult. Much later, you’ll grieve the time you lost with him while in a sickly fog, struggling to work and maintain a semblance of a life. You’ll find yourself making post-death requests to the universe, just in case there is an afterlife, to please let you come back and spend that time with your child. Please let you immerse yourself in those precious, fleeting moments, and enjoy and love him without the weight of illness and misery and constant worry that overshadows any joy life holds.”

“Then, a miracle will occur: like a phoenix rising from the ashes, little glimmers of your long-lost self will begin to return. You’ll remember who you are beyond this sickly, lost person. You’ll realize that beyond your suffering lies an untouchable spirit that will always exist. That illness cannot break you. It may seem to at times, but it cannot change who you are at your very core, no matter how much pain or suffering your body is experiencing. This thought will comfort you in inexplicable ways.”

“The second gift will be in recognizing the lessons which surviving hardship brought you – lessons about perseverance, inner strength, self-worth, confidence, humility, compassion, and forgiveness – and realizing you wouldn’t trade the growth born from these lessons, even if it meant reliving your health struggle all over again. (Though you will still long to have learned them less painfully, would that have been an option.) You’ll realize that, paradoxically, your isolating, alienating illnesses indirectly revealed your underlying connection to everyone you share the world with. You’ll know that although you wouldn’t consider illness a friend, it has certainly been one of your most powerful teachers.”

“You’ll know that saving even one person from the suffering you endured will be worth the potential disbelief, and even ridicule, that may come your way through the telling of your story. You’ll know that you no longer need anyone else to validate your illnesses, or any of your experiences, for that matter. Because, ultimately, your health ordeal has taught you to stand in your own truth with confidence – no matter what others believe, no matter how they might judge you.”

“We also need to change our response to people living with mystery illnesses our medical establishment does not yet acknowledge or understand how to treat, hopefully with more open-mindedness, curiosity, and compassion instead of judgment and dismissive skepticism. Think about this: didn’t most newly discovered illnesses, at one time, begin with a general lack of understanding and acceptance within the medical world? To act as though today’s medical knowledge base is static and impervious to change via new discoveries is misguided and harmful. But every time people – especially doctors – dismiss patients with a condescending disbelief in their illness, clinging tightly to old paradigms, they are effectively halting further scientific understanding for themselves, and potentially the rest of the world as well. They are also denying vital support, empathy, and care to people who suffer.”

Every word in FLUOROQUINOLONE POISONING: A TALE FROM THE TWILIGHT ZONE touches my soul.  It’s a profound and beautifully-written story, and I encourage you all to read it in its entirety (it’s 4 pages long, be sure to scroll through each page) and to share it with loved ones.  Thank you, Kristin, for speaking out so eloquently.

 

Taking Career Opportunities

People who read and follow Floxie Hope are often surprised to hear that I have a day job.  Yes, I spend a lot of time on Fluoroquinolone Toxicity advocacy.  No, it does not pay the bills.  So, I have one of those job things.

Today, May 27, 2015, is my last day at the job I’ve had since March 1, 2011.  I’m moving on to a similar organization (I’m leaving the names of both my current and future employer out of this… just ‘cause) where I’ll be doing the same line of work, but the new job will give me more responsibility, opportunities, and money.  It’s a step up in my career and I’m excited for the future.

All change is bitter-sweet though….. and a little scary.

I got floxed in December, 2011 and there was a time when I thought that I wouldn’t be able to do my current job, much less move on to a job that required more of me – more work, more intellect, more problem-solving, more travel, more energy, etc.  My reading comprehension, concentration, memory and ability to relate to others were horrible after I got floxed.  I didn’t feel capable of doing my job for months after the flox-bomb went off in me.  Things that I did with ease before I got floxed suddenly became difficult.  I had trouble doing the most basic tasks.  I was scared that I no longer had the mental capacity to do the tasks that were required for the job, and that I was going to get fired.

My fears were largely unfounded, because my employer was incredibly patient with me.  My boss and co-workers saw me go from being strong and athletic to barely being able to walk a block, and they were concerned.  They let me take time off of work to go to appointments as necessary.  They saw that my mobility was hindered and did thoughtful things for me – like getting my print-outs from the copier and bringing them to me.  They believed me, and told their loved ones to stay away from the drugs that hurt me.  I am forever grateful to them for their support, sympathy and kindness.  They are wonderful people and it’s a good organization.

Around one year post-flox I had an annual performance review with my boss.  I thanked him profusely for putting up with my loss of mental capacity.  He seemed perplexed by my assertion that my brain had been fried for the last year.  As far as he was concerned, I was doing fine.  I’m glad that my memory loss and other cognitive deficits weren’t as apparent to him as they were to me.  (Floxie friends – know that you may perceive your cognitive issues to be worse than others see them.  I know what it’s like to feel stupid, but you’re not stupid, and other people will be more forgiving of any mental lapses that you have than you will be toward yourself – so try to be kind to yourself.)

I will always feel grateful for my employer for standing by me while I was sick.  They may not see it as a big burden, but I see it as a great blessing that I am thankful for.

It is time for me to move on from a very good organization though.  I have opportunities to pursue, and I’m hopeful that my new employer will be as good to me as my last employer.

There was a long period of time – years – when I truly didn’t think that I would be capable of furthering my career and taking a job that required more of me.  I was grateful for my position, but I was trying my hardest not to lose what I had, and moving onward and upward weren’t possibilities that I could even consider.  Now those possibilities are a reality, and I have the capacity to take new opportunities.  It’s nice, and I’m thankful for the support in my past that has allowed me to get to these opportunities to better my future.

I hope that all my Floxie friends recover.  May you all be blessed with opportunities and improving health.  Both happened for me, and I am hopeful that they will happen for you too!  Hang in there – it gets better.

Hugs,

Lisa

 

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Keep Banging that Drum

I wrote a post last night that I was frustrated with upon completion. It’s not that it isn’t good. It is good, and it will be published – probably next week – on Hormones Matter. It’s that I was saying a lot of the same stuff that I’ve said before – Fluoroquinolones are dangerous drugs that damage mitochondria, lead to massive amounts of oxidative stress and contribute to all sorts of multi-symptom, chronic, mysterious diseases. I’ve said it before. I’ve said it in multiple ways. I’ve been as loud and as clear as I can be.

I was annoyed with myself because I don’t particularly want to be repetitive.

I wonder though, other than annoying myself, is repetition really a problem? For most people, it takes multiple times of hearing a message for it to sink in.

The first time they hear about the dangers of fluoroquinolones they resist the message. They think something along the lines of, “What are you talking about???? Antibiotics don’t do that. There’s no way cipro, levaquin or avelox hurts people like that. You must be mistaken.”

The second time they hear about the dangers of fluoroquinolones they start to make sense of what you are telling them. They think something along the lines of, “I’ve heard about how destruction of the microbiome wreaks havoc on many areas of human health – does that have anything to do with this?”

The third time they hear it, they may start to make a connection between what you say and something that they’ve seen or heard. They may think or say something like, “My friend’s son had something similar happen to him, I wonder if he’s taken one of those drugs.”

The fourth time they hear it, they start to understand. They may think or say something like, “Mitochondria are the energy centers of cells. OF COURSE when you damage mitochondria with fluoroquinolones the result is a shut-down of multiple bodily systems and chronic disease. And did you know that mitochondria are ancient descendents of bacteria? The damage done to human mitochondria is the same as the damage done to bacteria – it totally makes sense!”

The fifth time they hear it, they think that fluoroquinolone toxicity is common knowledge and common sense. They say things like, “Everyone knows that ciprofloxacin is a dangerous drug that should only be used in life or death situations.” Or, “Mito-toxic drugs are leading to all sorts of chronic illnesses – I wouldn’t touch a fluoroquinolone with a ten-foot pole.”

At that point, you can consider them to be won over.

Changing minds. Informing people. Changing the world. Those things are what all this screaming is about. I don’t spend 40+ hours per week researching and writing about the dangers of fluoroquinolones because I don’t have anything else going on in my life (I do have a job, a few hobbies and friends). I spend time and energy working on this BECAUSE IT’S IMPORTANT! People are being needlessly hurt by these drugs that have been shown, over and over again, to be damaging to human cells. It’s something that is worth screaming about. So I’ll scream, over and over again, until people hear me.

To change the world, perhaps a bit of repetition is needed. Annoying myself is a necessary sacrifice. I’m pretty sure I can do that.

Help in spreading the word about how dangerous fluoroquinolones – cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin, floxin/ofloxacin – are, is greatly appreciated! I know that it feels like your friends and family members think that you’re a kook when they’re in the phase of disbelief and resistance. But if you keep letting them know about how dangerous fluoroquinolones are, and how cipro, levaquin and/or avelox hurt you, eventually they’ll come around. Eventually they’ll believe you. Because you’re telling the truth. You have plenty of scientific studies on your side.

Keep screaming. I’ll keep writing. Eventually, we will get this changed.

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

 

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