Monthly Archives: December 2016

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

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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.

Neither Fluoroquinolone Toxicity, nor Recovery, are Rare

Last weekend I went to a seminar that has absolutely nothing to do with fluoroquinolones, drug safety, or advocacy. In that seminar I sat next to a guy who was roughly my age (30-something), and I began to tell him about my experience of getting hurt (poisoned) by Cipro/ciprofloxacin. I was about ten seconds into my story when he said, “Me too – Levaquin.” Yup, he was a fellow floxie. We chatted for a while, and exchanged stories of fluoroquinolone toxicity, then got back to the seminar.

There are a few things about my exchange with him that I’d like to share. First, he has largely recovered. He got hurt by Levaquin about a decade ago. He had severe musculo-skeletal problems (but not a lot of the nervous system symptoms that many floxies experience), and experienced pain in all the joints in his body. He went from being young, athletic, and capable, to barely being able to move. His pain and loss of capacity was so bad that he went through periods of contemplating suicide. Thankfully, he made it through those dark and painful times. He didn’t give me many details about how he got through the last decade, but he did heal. All of his joints (with the exception of his knees) are now strong and pain-free. He is able to work, socialize, and has recently started to exercise again.

The main thing that helped him was time. Knowing that time had helped others through similar experiences also gave him hope that his body would recover if he gave it enough time. For him, the amount of time that it took for his body to recover was a decade. I know that ten years is a long time, and for some of you it may sound like an unbearably long time. For others though, I hope that it is helpful and hopeful that time healed this guy’s body, and that maybe, just possibly, if you give yourself enough time, your body will heal too. (Of course, I don’t know how much time will heal you, or even if time will heal you, but I see it as hopeful that time healed him – even if it was a long time.)

The second thing that struck me about my conversation with this guy is that if two people meet in a random seminar, and both of them have had a life-altering adverse reaction to the same class of drugs, maybe that’s an indication that these reactions aren’t as “rare” as Bayer, Janssen Pharmaceuticals (a division of Johnson & Johnson), the FDA, and all others in the pharma machine would like us to believe. A floxie friend noted the following in a brilliant essay she wrote as part of a legal analysis about the alleged “rareness” of fluoroquinolone reactions:

Another way the risks are minimized is by listing these reactions as temporary or rare. The latter may be true in a technical sense, but what does ‘rare’ actually mean? A quick search of fluoroquinolone victim online support groups reveals that membership for most of them numbers in the tens of thousands, and the FDA’s Adverse Event Reporting System database garnered 3,101 reports of severe adverse reactions to fluoroquinolones in the last quarter of 2013 (the latest data available) alone. These are unscientific and anecdotal statistics, of course, but given that this class of antibiotic was prescribed to approximately 26.9 million patients during 2011 in the United States alone, ‘uncommon’ translates to 2.69 million domestic victims and ‘rare’ translates to 269,000. In fact, many more probably exist but are given a catch-all diagnosis of an ambiguous auto-immune disorder like fibromyalgia or are labeled with some other malady like diabetes, heart disease, hypothyroidism, etc., that arose spontaneously. Also, as in my case, a patient may take one or more courses previously without suffering an entirely noticeable reaction. Additionally, there is an unwillingness of medical professionals to admit a connection between the drug and these reactions. This is perhaps because, at first blush, it seems to defy logic that symptoms could take months to fully develop. But further research into biochemical complexities such as neurotransmitter and mitochondrial dysfunction is likely to explain why the damage follows a cascade-like pathological effect. For these reasons, the individualized nature of the reactions, and of course the patient’s illness itself, many victims surely never make the connection.

Of course disabling adverse reactions don’t happen to everyone who takes fluoroquinolones, but I still believe, as the author of the quote above does, that adverse reactions to fluoroquinolones are far less “rare” than pharma proponents would like us to believe, and that they are connected to many of the “mysterious” diseases of modernity for many.

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My encounter with the guy in the seminar also made me think that there are a lot more recovered “floxies” out there than most of us realize. In a comment on her story, Ruth noted:

My neighbor got floxed two months after I did. She made a 100% recovery. We had similar issues, but I was slightly worse than her. Until she talked to me she had no idea what had happened to her.

The music director for the parochial school/church where I worked two years ago got floxed, made an almost 100% recovery. She had some issues with her knee, having had a complete rupture of a tendon there and she is not young. But everything else resolved.

One of the pharmacy techs where I got the Cipro is a Floxie. She was very kind to me when I came there after my reaction. She was not there the day I picked up my prescription or maybe she would have warned me. She is 100% recovered.

My mother also knows someone who made a 100% recovery after a very bad reaction to a quinolone.

I don’t think that fluoroquinolone adverse reactions are rare, and I don’t think that recovery is rare. I also know that not everyone who gets hurt by fluoroquinolones recovers, and that there are many, too many, people who are permanently injured by Cipro, Levaquin, Avelox, Floxin, and their generic equivalents. Permanent injury, and Fluoroquinolone Associated Disability (FQAD), are not near as “rare” as they should be. None of the damage done by flurooquinolones is as rare as it should be. Too many people are getting hurt by these dangerous drugs. Even if many of them recover, poisoning people with dangerous and consequential drugs, when there are safer alternatives available, is wrong, and I hope that it stops soon.

 

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How Levaquin Tried to Kill Me, but I Fought Back

This is Amy’s story of fluoroquinolone toxicity and recovery. It’s wonderful! Thank you for writing this, Amy! I am so glad that this is not the end of you, and that this horrible experience has shown you how strong you truly are. xoxoxo

-Lisa

Amy Writes

img_5379I have a very serious story to share. I’ve put off writing it for a number of reasons: fear that writing it down gives it more power or permanence in my life, fear that the story isn’t actually over, shame that I allowed this to happen at all, especially given what happened to my dog Holly. That’s probably the biggest reason I’ve put off sharing this on the blog and on social media: I should know better than to just blindly trust a doctor prescribing medication. That killed my dog. And it could’ve killed me.

On April 20, 2016, my doctor (now former) prescribed a fluoroquinolone antibiotic called Levaquin (actually I took the generic, levafloxacin — more on that later) to treat a sinus infection. The only warning he gave me was to take a probiotic along with it, as it might upset my stomach. I’d been a…

View original post 3,146 more words

Holiday Gifts for Floxies in Need / A Gift Exchange

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Merry Christmas! Happy Chanukah! Festive Festivus! Happy holidays to each and every one of you!

I wish you all happiness, joy, love, and health this holiday season!

The holidays are supposed to be a time of warmth, comfort, and happiness, but, unfortunately, that isn’t how they are for everyone. For some people, the holidays can be difficult and lonely, and losses can feel amplified. For those who have had relationships strained by being sick, the holidays may be a reminder that some people don’t understand. For some, the holidays can emphasize losses of physical and mental capacity, as it becomes clear that you can’t do what you could before you got “floxed.” For those who have lost their ability to work, and who are struggling financially, the holidays can be particularly difficult.

Because I know what hardships many of my fellow “floxies” are experiencing, I thought I’d set up a gift giving program. Here is how it will work:

People who would like to give gifts to their fellow “floxies” will fill in the Gift Giver form –

https://goo.gl/forms/GqMPoWhY9INvDqdC2

People who would like to receive gifts from a friend in the “floxie” community will fill in the Gift Receiver form –

https://goo.gl/forms/fxgTRJueKCyT3X8z2

I will email a confirmation to the Gift Receiver that their request was received, and I will email the Gift Giver the necessary information to send gift to the Receiver.

The Gift Giver will send the gift to the Gift Receiver.

The world is a little more joyous and happy this holiday season.

Does that make sense? If not, please let me know.

Possible questions:

  1. How much will gifts for my floxie friend cost? How much should a thing I request cost?
    1. Under $50 (including shipping) seems reasonable.
  2. When do I need to send the gift? When should I expect to receive the gift?
    1. Try to get the gifts to people before December 24, 2016 (Christmas Eve and the first day of Chanukah).
  3. Are there any limits on who can receive gifts?
    1. You should be in need, and part of the “floxie” community, and I will trust you to self-identify as such.
  4. Are there any limits on who can give gifts?
    1. No.
  5. How are you going to match gift givers with gift receivers?
    1. Somewhere between randomly and first-come, first serve.
  6. What if there are more gift receivers than gift givers?
    1. I (Lisa) will send gifts to those in need who request some holiday cheer and love. There is also an option on the Gift Giver form to send more than one gift.
  7. What if there are more gift givers than gift receivers?
    1. Then we have a very generous community, and some people may get gifts from more than one person.
    2. If there are significantly more Gift Givers than Gift Receivers I will arrange a gift exchange where everyone is both a giver and a receiver.
  8. Is this anonymous?
    1. I’m not going to publish anyone’s personal information, but I’m not 100% sure how to use google forms so that they are completely secure, and I need to exchange information between parties. With that said, I will try to be discreet.

Please let me know if you have any questions or concerns. Thank you to all who participate!

I wish you all a wonderful holiday season full of love and cheer!

xoxo

 

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Floxie Hope Podcast Episode 16 – Amber

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I had the pleasure of interviewing Amber for Episode 16 of The Floxie Hope Podcast. You can listen to the podcast through either of these links:

http://www.floxiehopepodcast.com/episode-016-amber/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Note that all episodes of The Floxie Hope Podcast can be downloaded through any podcatcher. Just go to your app store, type in “podcatcher,” download whichever podcatcher you prefer, and search for “Floxie” – the podcast should pop up and you should be able to download it from there.

You can also read Amber’s story here – https://floxiehope.com/ambers-recovery-story-cipro-toxicity/

Amber’s fluoroquinolone toxicity symptoms included:

  • Brain fog – Even though I had a hard time concentrating I still had work and school and was not about to stop either.
  • Eye issues – including pain, light sensitivity, and dry eye.
  • Bee stings throughout my body
  • Vibration sensations
  • Muscle twitching
  • Pain in my legs- I had a hard time walking up the stairs to my apartment.  I would feel like I just ran a mile when I only took a few steps.
  • Anxiety
  • Sensitivity to alcohol and caffeine.
  • Sunburnt sensation all of my body
  • Hot spots on my legs
  • Migraines
  • Back ache

One thing to note is that Amber’s symptoms were significantly delayed. It’s difficult to connect cause to effect when a drug causes symptoms months after administration of the drug has stopped.

Amber’s message of hope to all of you is her encouragement to NEVER GIVE UP. When the “flox bomb” was going off in her, she had neurological problems and anxiety that were difficult to get through. She made it though. I hope that you find her story, and her podcast, to be encouraging!

 

 

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Oppose the 21st Century Cures Act – It Diminishes Patient Safety

I just sent this to everyone on the Floxie Hope email list. If you would like to sign up for the email list, you can do so through THIS LINK. Thank you for reading this, and for contacting your Senators to advocate for patient safety! 
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The 21st Century Cures Act passed through the U.S. House of Representatives last week, and it is anticipated that the Senate will vote on it this week–possibly as early as today. Please, please, please contact your Senators and ask them to reject this bill because it sacrifices patient safety and loosens regulations on pharmaceutical companies when they should be tightened.
Here are two posts I wrote about problems with The 21st Century Cures Act that you can forward or tweet to your Senators:
  1. Collective Evolution: “THE 21ST CENTURY CURES ACT” IS ON ITS WAY – HERE’S WHY YOU HAVEN’T HEARD ABOUT IT
  2. Hormones Matter: The 21st Century Cures Act Is Passing, No Matter How Many Patients Are Hurt
Additionally, here are some excellent articles about the dangers of The 21st Century Cures Act:
  1. New England Journal of Medicine: The 21st Century Cures Act — Will It Take Us Back in Time?
  2. STAT: 21st Century Cures Act will distort the meaning of ‘FDA approved’
I am sending the following to my Senators. Please feel free to send the same letter to your Senators:
Dear Senator ____,
I am writing to encourage you to reject The 21st Century Cures Act as it stands. The 21st Century Cures Act gives too much power to the pharmaceutical industry, and diminishes patient safety requirements at a time when they need to be strengthened. My reasons for opposing The 21st Century Cures Act include the following:
  1. With passage of The 21st Century Cures Act, approval of new pharmaceutical drugs and medical devices will be based on surrogate measures rather than actual improvement in health outcomes. This means that drugs and medical devices will be put into the market that have not been proven to save lives or successfully treat diseases.
  2. Lowering the standards by which the FDA approves drugs will diminish the meaning behind FDA approval. Neither patients nor physicians will be able to trust that FDA approval means that a drug or medical device is safe or efficacious if testing that shows safety and efficacy is not required.
  3. Too many people are currently being killed and sickened by pharmaceutical drug “adverse reactions.” Patient safety standards need to be strengthened, not reduced.
  4. The 21st Century Cures Act diminishes transparency and encourages bribery of doctors by pharmaceutical companies.
  5. Once a drug is approved, it is very difficult to get it removed from the market. The “fast track” provisions in The 21st Century Cures Act will allow dangerous drugs onto the market, and once they’re available, the FDA is reticent to remove them.
  6. The 21st Century Cures Act removes informed consent requirements for medical device, drug, and vaccine safety trials. It is imperative that we maintain informed consent.
  7. The 21st Century Cures Act fails to address concerns about drug safety and adverse drug reactions.
  8. The 21st Century Cures Act doesn’t focus it’s attention on disease prevention, and it will even exacerbate the problem of pharmaceutical-caused chronic illness.
  9. There are more than 1400 lobbyists with pharmaceutical companies fighting for this legislation, more lobbyists than any other bill, including the Affordable Care Act. This is a lobbyist-led bill, not a patient/consumer/constituent led bill. Yet patients/consumers/constituents will be affected by lower drug safety standards.
  10. The 21st Century Cures Act makes devastating cuts to Medicaid, with no plans to replenish the funds that are cut.

Thank you very much for your time and consideration! Please reject this bill as it stands, and revise it until patient protections are strengthened.

Thank you,

Lisa Bloomquist Palmer

 

This speech from Senator Elizabeth Warren goes over some of the problems with The 21st Century Cures Act:

Thank you to all of you who take the time to contact your Senators!

I have very little hope that this bill will be stopped in the Senate, but we can at least try.

I usually try to stay away from politics in both the Floxie Hope blog and email newsletter, but this bill diminishes patient safety–especially pharmaceutical drug safety–so I think it’s important that those of us who are fighting for safer pharmaceuticals speak out about it.

 

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Podcast Participants Wanted

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There are 15 episodes of The Floxie Hope Podcast available at http://www.floxiehopepodcast.com/ and https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010. Each interview on The Floxie Hope Podcast is valuable and informative, and I encourage each of you to listen to the stories of your fellow floxies by downloading the podcast.

So far, episodes of The Floxie Hope Podcast have been downloaded 14,500 times. Thank you to everyone who has listened to the podcast!

Unfortunately, I’ve gotten a bit lazy when it comes to recording and releasing new episodes of The Floxie Hope Podcast. I’d like to change my momentum, and start putting up new podcast episodes again. If you are interested in being interviewed for The Floxie Hope Podcast, please reach out to me. You can reach me through this Contact form (please note in your message that you are writing because you’re interested in being on the podcast):

Everyone who has a fluoroquinolone story to tell is welcome to be on the podcast. Though I think that listeners appreciate tips and advice, you don’t need to be recovered in order to share your story on the podcast. All are welcome.

In addition to stories from floxies, I’d also love to interview the loved ones of floxies. If a spouse, child, parent, or other loved one of a floxie wants to be on the podcast, I’d love to interview them too.

I’m available to do interviews most evenings and weekends. If you’re interested in sharing your story on The Floxie Hope Podcast, please let me know. Thanks, and I look forward to speaking to you!

 

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