Tag Archives: advocacy

Floxed Friday – The Rise of Floxie Education

Every Friday Michelle Polacinski, a Floxie as well as the Director and Producer of ‘Floxed,’ sends out a newsletter to those who have subscribed to the ‘Floxed’ newsletter. The Floxed Friday updates are always interesting and thoughtful, and Michelle has given me permission to share them here. 
 
If you would like to receive the Floxed Friday updates directly from Michelle, please subscribe to the Floxed Documentary email list. You can subscribe through THIS LINK. Subscribing also helps Michelle to gain funding for the Floxed Documentary, and she doesn’t send out spam. 
 
The following was written by Michelle: 

We’re in Los Angeles, home of the entertainment industry, the most prevalent researcher on Fluoroquinolone Toxicity, nostalgia, and the doctor that floxed me. Ahhh it’s good to be home… and it’s weird to be home.

We’re shooting two very important interview subjects out here and we are very excited about what’s to come. During every interview, we learn something new that we didn’t know before. Did you know that on certain tests that doctors have to take in med school, “Cipro” is the answer to “What do you prescribe for a UTI?”

That was the case back then, but it’s not the case now.

Before diving headfirst into the entertainment industry, I was on track for medical school. I attended a pre-med summer camp for interested high school students in Boston, where I wore pant suits and attended conferences with a coffee in my hand as if I were a full-blown adult.

In college, I took classes on Animal Behavior and Microbiology, auditing Immunology by accident, and making friends along the way.

A lot of these friends, but not all, ended up making it to medical school. I was eternally grateful when they flooded me with facebook messages, skype calls, emails, and texts asking me the details about what happened to me. They were both alarmed and very curious.

Early into med school, they didn’t know much about what to expect, but a few years later, those same people reached out to me again, “just to let me know” that they had just taken an entire lesson on Fluoroquinolone Toxicity Syndrome and that they were told only to prescribe fluoroquinolones in near-death situations.

Naturally, my former academic peers shared my floxed story with their classmates and later, I had messages from other friends in nursing school who learned about FQT/FQAD.

At Chowder Fest this year, a woman made a sly remark about my “intelligence” when I propped the door to the bathroom open with a garbage can and we ended up talking about Fluoroquinolone Toxicity Syndrome just for a girl who was peeing to raise her arm over the stall and scream, “Is that CIPRO?” She learned about it in a Biology class studying for her Bachelor’s Degree.

I know it’s hard to have hope if you’ve been floxed, particularly if you’ve shown no signs of improvement, but there is hope in education. There’s hope in the future.

We hope that once finished, we can use this documentary as an educational resource for doctors and other medical professionals alike. Just talking about it seems to spark awareness and hopefully, change.

Have a great weekend!

Best,
Michelle Polacinski
Floxie, Director, and Producer of ‘Floxed’

*****

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

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

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

He, and his co-authors, state:

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

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

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

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

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

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

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

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

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

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

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

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

*****

Writer’s Block, Advocacy Works, Getting Stronger, and Rivers Full of Antibiotics

I am having horrible writer’s block, and I haven’t thought of a thing to write for floxiehope.com in a while. I apologize for the neglect, but I’m really struggling with finding the time, energy, and motivation to write about this very important topic.

This post consists of the few FQ-related thoughts that have been running through my brain lately, but it’s not a very fluid or comprehensive post, and I apologize for that.

If you are interested in helping me to keep this site active and relevant by writing a guest-post, I would greatly appreciate your help! Here is a link with info about writing for Floxie Hope:

https://floxiehope.com/2017/12/07/write-for-floxie-hope/

If you have topic requests that you would like me to write about, I am open to suggestions. Please don’t hesitate to contact me.

*****

I have been meaning to write a post about the recent finding that most of the planet’s rivers are polluted with antibiotics. This is a topic that deserves its own post, but I haven’t gotten around to it yet. Anyhow, here are some articles about this awful travesty:

  1. The Guardian, “World’s rivers ‘awash with dangerous levels of antibiotics: Largest global study finds the drugs in two-thirds of test sites in 72 countries
  2. CNN, “The world’s rivers are contaminated with antibiotics, new study shows
  3. National Geographic, “First global look finds most rivers awash with antibiotics: Almost two-thirds of the rivers studied contained enough antibiotics to contribute to the growing problem of antibiotic-resistant bacteria.

Nothing about this is okay. Rivers have microbial communities that need to be alive for the health of the river and all the life within it. Killing bacteria throughout a river ecosystem is wrongheaded and likely horribly consequential for all the life in the river. As people ingest the water from the river, they are getting dosed with antibiotics, some of which are fluoroquinolones, and thus increasing their risk of suffering from fluoroquinolone toxicity and other adverse-reactions to antibiotics. Constant low-level ingestion of antibiotics is horrible for the human microbiome too, and microbiome destruction and imbalance is linked to many diseases. And, of course, low-level constant dosing of antibiotics leads to antibiotic resistance (the main problem that these articles focused on). It’s awful and tragic and depressing.

*****

On a happier note:

I went on a hike this weekend with my Dad and a couple of his friends. One of his friends mentioned that her 90-year-old father was saved from getting floxed because she was aware of the dangers of fluoroquinolones and told the doctors in no uncertain terms that they were not to give her elderly father these dangerous drugs. She was aware of the dangers of fluoroquinolones because of my advocacy efforts, and it felt really good to hear that from her. We know each other through my dad, not through any of my patient-advocacy work. Still, she heard and she listened, and she kept her father away from these dangerous drugs. One person at a time – the word is getting out and people are listening. Keep posting about the dangers of fluoroquinolones. Keep screaming about the damage these drugs have done to you or your loved ones. People are listening.

Here are some posts on both spreading the word about fluoroquinolone toxicity, and people listening:

  1. Friends Don’t Let Friends Take Fluoroquinolones: Four Stories
  2. Keep Banging That Drum

*****

I have been hiking a lot lately. Though I have been on dozens of hikes post-flox, something has shifted recently. I am strong again, and I’m capable of getting stronger quickly. Strong and capable of building muscle easily and quickly was how I described myself before I got floxed. Cipro made me feel weak and incapable, and I certainly didn’t describe myself as strong post-flox. After I recovered from the acute phase, I could move and exercise moderately, but I never felt like I was increasing my capacity or getting stronger. Lately, I have returned to feeling strong. I went on two pretty intense hikes this weekend (both about 5 miles, with a significant amount of elevation gain), and I felt strong during and after both of them. I have been doing after-work 50-minute hikes lately that have been getting easier and easier. It feels really good to not only be capable, but to be strong and fit. I didn’t feel that way for a very long time.

As always, I mention these gains not to brag or to make light of the horror of fluoroquinolone toxicity, but in hope that my recovery gives you hope for your recovery.

Love and hope for recovery for all of you!

Hugs,

Lisa

*****

 

 

EMA Committee Recommends Restricting Fluoroquinolones

The European Medicines Agency (EMA) put out the press release entitled “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” on November 16, 2018. It goes over the recommendations of the EMA’s Committee for Medicinal Products for Human Use (CHMP), and expands on the earlier recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC). Following are some highlights from “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.”

“The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.”

This is a strong statement from the EMA. It is recommended that the fluoroquinolones that remain on the market in Europe (including, but not limited to, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and norfloxacin) will be restricted, and patients and healthcare providers alike will be given information about the disabling effects of these drugs. That’s a HUGE step in the right direction!

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

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

This list is great, and if it, combined with the US FDA’s list of ailments for which fluoroquinolones should not be used, is followed, fluoroquinolone prescriptions will be cut significantly.

I am particularly pleased to see that the EMA is recommending against use of fluoroquinolones for treatment of chronic prostatitis. Too many men have been severely injured by fluoroquinolones given to them for treatment of non-bacterial prostatitis, a condition for which fluoroquinolones are no better than a placebo.

It is also wonderful to see that the EMA is recommending against the prescription fo fluoroquinolones for prevention of traveller’s diarrhea/diarrhoea. No one should ever be prescribed a drug as dangerous and consequential as fluoroquinolones “just in case” they get traveller’s diarrhea.

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

Yes – exactly – fluoroquinolones should be avoided in people who have previously experienced side-effects from fluoroquinolones. More information about that can be found in “The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones.”

I would say that fluoroquinolones should never be used on patients who are elderly, who have kidney disease, or who have had an organ transplant, but use “with special caution” is a step in the right direction.

“The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.”

Stay tuned. I’ll highlight the final decision made by the EMA once it is published.

The EMA press release, “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” also contains the following guidance for patients:

Information for patients

  • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
  • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
  • Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.
  • Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases:
    • at the first sign of tendon injury, such as tendon pain or swelling – rest the painful area;
    • if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
    • if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.
  • You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.
  • Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
  • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
  • If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.

And it also contains the following guidance for prescribers:

Information for healthcare professionals

  • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
  • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
  • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
  • Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
  • Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.
  • Fluoroquinolones should generally not be used in patients who have had serious adverse reactionsassociated with the use of quinolone or fluoroquinolone medicines.
  • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. This is because the indications for these medicines have been restricted.
  • The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour.

Healthcare providers should also be informed that there is no known cure or remedy for fluoroquinolone toxicity, and that the effects of these drugs can be permanent.

This information should also be given to patients.

Overall, I’m pleased with the CHMP recommendations, and I’m hopeful that the final, binding ruling from the EMA is as strongly worded, and even more comprehensive.

*****

EMA Decision on Fluoroquinolones – Next Steps

The EMA (European Medicines Agency) review of fluoroquinolones is ongoing, and your input is requested/needed.

On June 13, 2018, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) heard testimony from Europeans who suffered from fluoroquinolone toxicity, and on May 10, 2018, the PRAC issued their recommendations. (You can read and view the patient/victim testimonials HERE, HERE, and HERE, and you can read the PRAC’s recommendations HERE.) The next step is for the Committee for Medicinal Products for Human Use (CHMP) to consider the recommendations of the the PRAC on the safety of medicines on the market and recommend changes to the EMA. The CHMP will recommend changes in the marketing of fluoroquinolones, or may even recommend suspension or withdrawal of fluoroquinolones from the market. You can read more about the role of the CHMP HERE.

I would like to encourage everyone who has been hurt by fluoroquinolones to contact the CHMP so that they can take your testimonials and information into consideration when making their decisions and recommendations. Contact information for the CHMP members can be found HERE. I recommend that you send an email with a brief version of your personal story, along with information and references from the articles about fluoroquinolone toxicity that can be found in the “research” section of the Links & Resources page on this site or elsewhere on the internet to both the CHMP Chair (Harald Enzmann) and the Vice-Chair (Bruno Sepodes) I plan to send a letter that contains a combination of the information in the post, “What is Fluoroquinolone Toxicity” and the information that is found in the ebook, Hacking Fluoroquinolones (I’ll post my letter once I write it). You are welcome to use anything I (Lisa Bloomquist) have written on this site, or in my guest-posts on other sites, in your letters to the CHMP.

The CHMP meeting starts on November 12, 2018, and it is recommended that you send your emails to the Chair and Vice-chair of the CHMP as soon as possible.

Miriam Knight, a fluoroquinolone toxicity victim advocate, co-founder of Quinolone Toxicity Support UK, and an administrator for Fluoroquinolone Toxicity Victims in Europe, has written the following letter, and you are welcome to use it as a template. 

Dear Chair, Vice-chair and other members of the Committee for Medicinal Products for Human Use,

We in Europe wish to express our strong concerns regarding the recent recommendations made by the PRAC following their lengthy review into the side effects of Quinolones and Fluoroquinolones. We understand that the recommendations have now been passed to the CHMP for your opinion. We are very disappointed in the findings so far.

Representatives of this group and also individual members from across the EU were invited to speak at PRAC’s Public Hearing in June. From the EMA website we understand that “Contributions at public hearings inform the committee’s decision-making”. Even after taking part in the teleconference last week we are unable to find any evidence in the recommendations that our written and spoken interventions have in any way been used to inform the PRAC’s decision making.

Our main concern is that the evidence which we and others have provided regarding the damage Fluoroquinolones cause to human mitochondrial DNA (MtDNA) has been totally ignored. This evidence has been in the public domain since 1993 (1,2,3), yet is not mentioned in any of the license applications, SmPCs or PILs. Both the summary of the Public Hearing and the recommendations from the review fail to mention it, despite the overwhelming evidence. We despair that the Agency charged with safeguarding Public Health cannot see the huge danger in licensing products that physically damage humans. We hope that the CHMP and the Pharmacogenomic Working Party will at least understand the implications of this mechanism of action and will take the time to study ALL of the available evidence.

The Medical Profession seem to have a problem understanding how and why the Fluoroquinolone class of antibiotics have such wide ranging effects on some patients, indeed most are unable or do not believe patients when they are told of these side effects even with written and recorded evidence (4). It is clearly within the remit of the Pharmacogenomics Working Party to provide advice to the CHMP on general and product-specific matters relating to pharmacogenomics, although perhaps this aspect of the review was beyond the scope of the PRAC.

Not only do Fluoroquinolones have an effect on MtDNA but they also disrupt the metabolic processes of both our mitochondria (e.g. the TCA cycle) and also our cells (5,6). Again, the evidence for this has been glossed over by the PRAC’s recommendations, despite the many testimonies at the Public Hearing attempting to convey the sheer agonising horror inflicted by these drugs.

We understand from the teleconference that the recommendations passed over to the CHMP are more detailed than the brief version that was published prior to the teleconference. We sincerely hope this is so as all we have seen so far is a tenuous nod towards implementing changes with a view to protecting the public. The biggest risk to human health from the Fluoroquinolones is the damage and destruction caused to every cell (6) – which can potentially lead to multisystem problems including organ failure and cancers (4), and which surely outweigh the benefits. The mitochondrial damage also has implications on second generations – something which has yet to be studied. We notice that the PRAC dropped their original proposal to encourage further studies and research to be undertaken with no explanation. We find this decision, along with all of PRAC’s expressed concerns, to be disingenuous, at the least, at most we find it dangerous to future victims as well as present victims.

We cannot urge strongly enough that you fully and properly review all the evidence showing the catastrophic effect Fluoroquinolones can have both physically and mentally (4). A full understanding of why some people are affected immediately while others can tolerate several courses needs to be taught throughout the medical profession. It is simply not good enough to say these effects are “very rare” when it is well known that many people, after experiencing nothing from a first course go on to be affected by a second or third course. Others seem to tolerate repeated courses before just one more tablet sets off a serious reaction. The variety of personal thresholds is believed to depend on the individual’s mitochondrial condition, including either congenital deficiencies or acquired insults.The reality is that if someone takes enough Fluoroquinolones, they will eventually be affected: this cannot be defined as “very rare”. The true figure is unknown and until extensive research is undertaken it will remain unknown.

It is also not good enough to say these effects are “very rare” when it is well known that neither doctors nor patients associate an ADR that occurs weeks or months after cessation of the Fluoroquinolone with that particular drug – yet this is precisely what happens. There are possibly thousands of people who have been affected yet never know; their symptoms often labelled as Fibromyalgia or CFS/ME (which, ironically, have no known cause) or even MS.  Many times we have heard of e.g. eye specialists saying they have prescribed Fluoroquinolones hundreds of times yet no one has reported any problems: why would a patient with sudden muscle or tendon problems go back to their eye specialist? More patients have been seriously affected by Fluoroquinolones than anyone can imagine.

All Medical Professionals, member state Health Agencies and ALL committees working within the EMA have to fully understand the human catastrophe caused by this unique class of drugs (not exactly antibiotics as they have also been used as chemotherapy agents). Until the naïve ‘one size fits all’ approach to medicine is overturned – and this is obviously where the Pharmacogenomics Working Party is essential – innocent patients will continue to be harmed by the innocent doctors who are trying to do no harm.

References*:

1). Acridones and quinolones as inhibitors of ubiquinone functions in the mitochondrial respiratory chain. July 1993 Walter Oettmeier et al
https://pdfs.semanticscholar. org/a9fd/ 33039c3d987093746db40fbd8d7782 f3b078.pdf
2). Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells. Nov 1996 Lawrence JW et al.
https://www.ncbi.nlm.nih.gov/ pubmed/8913349
3). Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 August 2018 Hangas et al
https://academic.oup.com/nar/ article/46/18/9625/5088042? fbclid= IwAR0Xu4wIXprB3wF6nBP2EZxWinNm mVvUvjIQ8GPHPaLS81KsxE_ ucJZ99K8
4). Fluoroquinolone-induced serious, persistent, multisymptom adverse effects.
Oct 2015. Golomb B. et al
http://casereports.bmj.com/ content/2015/bcr-2015-209821. full
“…with progression that continued following discontinuation evolving to a severe, disabling multisymptom profile variably involving tendinopathy,muscle weakness, peripheral neuropathy, autonomic dysfunction, sleep disorder, cognitive dysfunction and psychiatric disturbance..”
5). Exploiting bacterial DNA gyrase as a drug target: current state and perspectives
Nov 2011 Frédéric Collin et al.
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3189412/
6).Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications
Nov 2017. Michalak K. et al .
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC5632915/

* These few references have been chosen as the most relevant to this letter.  The PRAC tell us they studied over 400 papers before reaching their decision but have not yet told us which 400.  As all scientists know, it is possible to reach any conclusion you like depending on which papers you quote. There are many more than 400 papers available which show the harm that can be caused by Fluoroquinolones.  Perhaps the best way to judge the danger is to work with the actual sufferers (we are either sufferers or carers ourselves) – as Dr Golomb (4) has done.

Thank you, Miriam, for all your advocacy work with the EMA (including the PRAC and CHMP)! And thank you to all who reach out to the CHMP – your advocacy work is appreciated too!

The PRAC recommendations were disappointing for many fluoroquinolone victims and advocates. Hopefully the CHMP recommendations will be stronger and more protective of patients.

Fluoroquinolone Toxicity Films

I have come to the conclusion that being a film-maker is a risk factor for having an adverse reaction to fluoroquinolones. I have been emailed by no less than a dozen people in the film industry, mainly independent documentarians, who have been floxed and who express desire to make a film about fluoroquinolone toxicity. I haven’t been approached by authors, or people who are on the radio, or any other type of media personnel – only film-makers. Film-makers beware – DO NOT TAKE FLUOROQUINOLONE ANTIBIOTICS.

Of course, I’m joking. It is illogical, and impossible, for film-makers to be at higher risk of fluoroquinolone toxicity than anyone else. Film-makers shouldn’t take fluoroquinolones because no one should take fluoroquinolones, but I see no reason that they would be at higher risk of fluoroquinolone toxicity than anyone else.

Still…. I have gotten several, maybe dozens, of emails from floxed film-makers who have expressed interest in making a film (or documentary, sorry, I don’t know the difference) about fluoroquinolone toxicity. I applaud their initiative and I encourage anyone/everyone who is interested in making a film about fluoroquinolone toxicity to do so.

The more the merrier, and if there were 20 films about fluoroquinolone toxicity, that would be awesome. However, maybe it would be good for the many film-makers who are interested in fluoroquinolone toxicity to join together and combine their talents, efforts, finances, and resources – just a suggestion.

Over the years, I have lost track of most of the emails from floxed film-makers. On the off chance that some of the floxed film-makers follow this blog, and are interested in collaborating, I would like to offer to connect you. Please contact me using the following form if you want me to connect you with others who are interested in creating a film about fluoroquinolone toxicity:

Though many film-makers have noted their interest in creating a film about fluoroquinolone toxicity, I only know of one who is currently in the process of making one. Michelle P is currently working on “Floxed”. Please “like” her page on facebook and support her efforts. There is a “send message” button on the Floxed documentary facebook page, and that’s probably a better way to reach Michelle than the contact form above, but I’m still happy to facilitate connections.  https://www.facebook.com/floxeddoc/

There are a couple of finished films about fluoroquinolone toxicity that I recommend. The first is Certain Adverse Events, by Nancy Edwards. You can purchase Certain Adverse Events on Amazon – https://www.amazon.com/Certain-Adverse-Events-Nancy-Edwards/dp/B0076D0B2G.

One of the 5-star reviewers of Certain Adverse Events states:

“I will never forget the date of 3-1-10. That’s the day I took a week long course of Cipro and went from being a very athletic and healthy 42 year old professional to a disabled cripple in one short week. That’s how devastating the side effects from these drugs are. Two years have passed since then and I am still in chronic pain with major nerve, tendon and cartilage damage throughout my body. This film does a great job of showing how many people are affected by this class of antibiotics and why the US regulatory system has thus far failed to properly regulate these drugs. It interviews victims, doctors, pharmacists and lawyers to help you make an informed decision on your own health. I wish I’d seen this film before it was too late for me.”

Here is an excerpt of the film on youtube too (but please buy it on Amazon – support independent film-makers who are drawing attention to an important issue – thank you):

Another film that features fluoroquinolone toxicity is a fiction (or whatever the equivalent word about films is) film called The East. I wrote about The East in the post, “Fluoroquinolone Toxicity Featured in the Movie ‘The East'”. Here is a trailer:

Please watch, and share, these films, and support the people who are making new films about (or featuring) fluoroquinolone toxicity – thank you!

*****

Survey to Make Medicines Safer

I have followed holistic health coach, advocate, and blogger Alison Vickery for a while. Her site, http://alisonvickery.com.au/ has an immense amount of information about “mysterious” chronic illnesses, and it has particularly interesting and insightful information about histamine intolerance.

Many “floxed” people suffer from histamine intolerance, and/or their symptoms of fluoroquinolone toxicity overlap significantly with the symptoms of histamine intolerance and mast cell activation. Sites such as Alison’s have a wealth of information and resources for those suffering from histamine intolerance and mast cell activation – whether those were brought on by fluoroquinolones or another cause. Many pharmaceuticals, including fluoroquinolones, can trigger histamine intolerance, and the post, “Medicines That Cause Histamine Intolerance” goes over them. I suggest that all of my floxie friends (if you are reading this, I consider you to be a floxie friend) check out alisonvickery.com.au, and that you look into histamine and mast cell activation as they relate to fluoroquinolone toxicity. The post on this site, “Can Fluoroquinolones Activate Mast Cells?” gives some information on the connections between fluoroquinolone toxicity and histamine intolerance and mast cell activation.

Obviously, I think highly of Alison’s work. However, her work on histamine intolerance and mast cell activation are not the main point of this post. The point of this post is to ask for your help with some patient advocacy efforts that Alison is involved in. Alison is currently petitioning/lobbying the Australian government to change how they warn people about dangerous pharmaceuticals. In order to get them to recognize the severity of adverse reactions, and to show that there is support for changing the way that adverse-effects of pharmaceuticals are communicated, she has asked that people who have been hurt by pharmaceuticals complete a survey. This note from Alison explains what she is seeking:

“I am working to lobby the Australian Government on changes and also unite consumer voices to increase the volume. I am wondering if you would share a survey with your followers on boxed warnings. In Australia they are seeking consumer submissions on boxed warnings and also within one month there is going to be a working group on antibiotics. I have been asked to be a consumer representative. At the moment I have virtually no people responding about being floxed. I would also like consumer stories (anonymous to share). They don’t have to be Australian to participate. Is that something you would feel comfortable doing? You’re welcome to ask me any more questions.”

The survey link is – https://www.safemedicines.com.au/boxed_warnings

It is a short survey–it only took me a few minutes to complete. The survey also gives you a chance to tell your story. Please take a few minutes to complete the survey and have your voice be heard. As Alison noted, you don’t need to be Australian to participate.

Alison also stated, “I have come to the conclusion (after getting an inquiry up) that they (the Australian government / regulators) don’t need more information, they are just not scared enough of us yet. The only way is for us to join together. I have no agenda other than to stop people getting hurt. Also if we can get this up in Australia it sets a precedent for others to run with. Any help or support you can give would be awesome.”

And any support that you (floxie friend reading this) can give will be awesome. Thank you in advance those of you who take the time to complete this survey!

The site that the survey is on, https://www.safemedicines.com.au/ Australian’s for Safe Medicines, is also a wonderful site with a great mission. The “Meet Us” page states:

We are a consumer-led association of individuals.

 

We are not for medicines

We are not against them

We are for safe medicines.

 

We seek to empower you, the consumer to;

 

Make informed decisions on medicines

Voice your concerns about medicine safety (including unsafe prescribing practices and your need for new medicines)

Voice your support for any stakeholder striving to make a real difference to medicine safety, and

Disrupt any and all stakeholders that allow unsafe medicine practices to flourish.

 

Do you take

Have you taken or

Are you considering taking medicine?

Will you stand with us for safe medicines?

#mylifematters

 

Indeed, #mylifematters. So does yours. Your voice matters too, and telling your story through surveys such as this one, is immensely helpful. Thank you for your help!

 

 

Advocacy Opportunity – FDA Meeting to Discuss Fluoroquinolones

ADVOCACY OPPORTUNITY 

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

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

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

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

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

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

More information can be found in these announcement links –

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

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

THANK YOU!!!

 

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Quinolone Vigilance Foundation (QVF) Update

Quinolone Vigilance Foundation (QVF) Update

I asked Rachel Brummert, President of the QVF, to update the January, 2014 post about the QVF – https://floxiehope.com/2014/01/29/the-quinolone-vigilance-foundation-qvf/.  It turns out that a lot of updating needed to be done, so I’m making the update a whole new post.  Thank you to everyone involved with the QVF for all your efforts!  

There is a non-profit, charitable foundation devoted to raising awareness about the dangers of fluoroquinolone antibiotics and fluoroquinolone toxicity, advocating for victims, educating the medical community, and to funding research on fluoroquinolone toxicity. It is called The Quinolone Vigilance Foundation (the QVF) – www.saferpills.org.

Following is some information about the QVF:

History and Purpose

The QVF is a registered 501(c)(3) non-profit foundation established in 2009 and Incorporated in 2012. Its founders sought to establish professional credibility by reviewing the existing scientific literature that addressed adverse reactions from fluoroquinolones; recruited and networked medical researchers; and stimulated new research into this poorly understood issue. The QVF branched out in 2014 to educating the medical profession.

“Our mission is four-fold: Educating the medical profession about fluoroquinolones, advocating for victims of fluoroquinolone toxicity, raising awareness in the United States and abroad, and research. Advocacy, education, and research go hand in hand and gives a complete picture of the problem. Helping victims already affected and getting ahead of it so damage doesn’t happen in the first place is something we are very passionate about and we work hard to achieve,” explains Rachel Brummert, Executive Director of the QVF.

Advocacy and Outreach

  • In the spring of 2014, the QVF began educating doctors in local practices and major medical centers.
  • QVF has held six fundraisers since 2013 to raise funding for advocacy and education, and for the University of Rochester research study.
  • QVF sells awareness merchandise:

www.cafepress.com/quinvigil

https://www.bravelets.com/bravepage/fluoroquinolone-life-qvf

http://konectidy.com/charity/quinolone-vigilance-foundation/

  • QVF is in early stages of bringing in two new research studies.
  • QVF attended two FDA Hearings
  • QVF continues to work with media outlets to warn viewers of the dangers of fluoroquinolone antibiotics. We provide information to reporters and assist in finding victims to be interviewed.
  • QVF receives many requests from doctors offices and pharmacies for brochures and awareness cards to display. We also offer free brochures to anyone who wishes to pass them out in their communities. In addition, we offer downloadable brochures on our website under the Resources tab for anyone who wishes to print them out themselves. http://www.saferpills.org/print-download/
  • Author, actor and international speaker Josh Rivedal asked QVF to participate in the i’Mpossible Project and the upcoming book The i’Mpossible Project: Volume 1 Reengaging With Life, Creating a New You due to be released on January 13, 2016 and available for pre-order on September 16, 2015. Per an agreement with the publisher, 100% of proceeds made from our contribution to the book will be donated to QVF and no person shall personally gain from the book. QVF has been approached by several media outlets to discuss the book and about the topic of fluoroquinolone toxicity. The book will be available in paperback and e-book, at major bookstores like Books A Million, Barnes & Noble and Amazon, and online as an ebook at BN.com, Kindle, iTunes, Nook, and Google Books. The i’Mpossible Project is a collection of powerful stories. The stories in this first volume are all about overcoming obstacles, reengaging with life, and creating new possibilities. Among the other authors are Academy Award Winner James Lecesne, and actress Ali Stroker of Fox’s GLEE. We are honored to participate and to bring fluoroquinolone toxicity awareness to an international audience.
  • QVF produces awareness videos which can be readily shared to spread awareness and participates in podcasts and radio shows.

Television Media stories featuring QVF volunteers

Arizonahttp://www.abc15.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Arizonahttp://www.azcentral.com/videos/news/local/arizona/2014/11/04/18450053/

Michiganhttp://www.wxyz.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Indianahttp://www.theindychannel.com/news/u-s-world/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Florida- http://www.wptv.com/money/consumer/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Ohiohttp://www.wcpo.com/news/health/healthy-living/levaquin-popular-antibiotic-carries-side-effects-not-listed-on-label

Californiahttp://www.10news.com/news/investigations/patients-experts-popular-antibiotics-could-cause-permanent-damage-11242014

Georgiahttp://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/

Georgiahttp://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/

Georgiahttp://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/

Californiahttp://losangeles.cbslocal.com/2015/03/04/southland-firefighter-says-popular-antibiotic-stripped-him-of-his-career/

Missourihttp://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker

Virginiahttp://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/

Virginiahttp://wric.com/2015/05/20/8news-investigates-doctors-left-in-dark-about-prescription-drug-dangers/

Articles featuring QVF

Care Novate: http://carenovatemag.com/personal-account-prescription-destruction-black-box-warning/

United Kingdom: http://born-in-newyork.com/ciprofloxacin-antibiotic-resistance/

Washington Post: http://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e

Tulsa World: http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html

Connecticut- http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html

Italy: http://m.ilgazzettino.it/m/gazzettino/articolo/NORDEST/1270894

QVF Staff/Volunteers

The QVF is comprised of a board of directors, non-board volunteers, and ambassadors/advocates from all over the world: The United States, Canada, Ireland, the United Kingdom, Belgium, Australia, Algeria, and Italy.

The current volunteer staff positions are as follows:

Board

Rachel Brummert – Executive Director and President

Matthew Arnold – Vice President

Donna Schutz – Assistant Director and Ambassador Coordinator

Leslie Day – Corporate Secretary

Christina Manthos -Sorrell – Treasurer

Dr. Deanna Minkler – General Board Member

Dr. Joe Hudak – General Board Member

Non-board

Victoria Chiovare – Assistant Fundraising Director

Jenny Frank- Public Relations Director

All QVF positions are staffed by volunteers who generously donate their time and talents to promote the mission and values of the organization. No one within the organization receives compensation of any kind.

More information about the QVF can be found on www.saferpills.org and you can sign up for quarterly newsletters to keep up to date on QVF projects and activities.

To donate to QVF: donations@saferpills.org. All donations are tax deductible.

 

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Progress Gained in Fluoroquinolone Toxicity Awareness

A lot of awareness of fluoroquinolone toxicity has been gained in the last few years.  In 2011, when I got floxed, the biggest facebook support group for “floxies” had about 600 members, news stories about fluoroquinolone toxicity were few and far between, and people seemed to be reluctant to share information about fluoroquinolones on their social media accounts. Today, the biggest facebook support group for floxies has almost 4,000 members (and many people have come and gone, so there have been more than 3,400 people who are aware enough of fluoroquinolone toxicity to join the group), news reports about the dangers of fluoroquinolones seem to come out on a weekly basis, and people are screaming about the dangers of fluoroquinolones in every way they can – through their social media accounts, telling their personal stories on web sites, commenting on news stories, and through talking to their families, friends, doctors and anyone else who will listen to them.

We’re making progress. We’re getting louder and stronger.

Even the FDA, the slow-moving behemoth that it is, has made some movement toward acknowledging the dangers of fluoroquinolones. In 2013 the warning label for fluoroquinolones was updated to note that PERMANENT peripheral neuropathy is a possible adverse effect of fluoroquinolones. The FDA stated that this change to the warning label was because of a review of AERS (Adverse Event Reporting System) data that found that many people were reporting disabling peripheral neuropathy as an effect of fluoroquinolones. AERS reports are patient reports. The FDA is listening to our screams.

The warning label change prompted a slew of lawsuits against Bayer (the maker of Cipro and Avelox) and Johnson & Johnson (maker of Levaquin), that hopefully will give some people justice and compensation for the harm that fluoroquinolones have done to them. Just having the door opened for justice is a step in the right direction – it’s progress.

In September, 2014 Dr. Charles Bennett filed two Citizen’s Petitions with the FDA asking them to change the fluoroquinolone warning labels to note “mitochondrial toxicity” and “psychiatric adverse effects.” The FDA’s response to those petitions is still pending, but the petitions themselves are valuable, both in that they are communications with the FDA, and that they give victims of fluoroquinolones credibility.

More than 60 news stories about the dangers of fluoroquinolones have aired in the last year. Each of these news stories was made possible by people reaching out to the news media. They wouldn’t have happened without people advocating for themselves and speaking up. With each news story, the word spreads about the dangers of fluoroquinolones, and the more people are aware of fluoroquinolone toxicity. With awareness of the dangers of fluoroquinolones comes avoidance of them, and that’s certainly progress.

One of the most influential news-stories about fluoroquinolones was “Local woman says popular antibiotic killed her husband” which aired on WSB-TV Atlanta. It had more than 135,000 social media shares, and Levaquin prescriptions in the Atlanta area dropped dramatically after it aired. It not only successfully spread the word about the devastating effects of fluoroquinolones, it changed prescription rates for fluoroquinolones. That’s huge! (Though, of course, it is horrible that Chris Dannelly lost his life. My eternal condolences to his family.)

A lot of progress in awareness of fluoroquinolone toxicity has been made through social media. When I first got floxed, people didn’t mention fluoroquinolone toxicity on their social media pages. There seemed to be a lot of silence, and even shame, around it. Now there are people who share information about the dangers of fluoroquinolones on their social media accounts regularly. With every “share” or “like” people are reached and progress toward awareness is made. Every little step rolls the ball in the right direction and gives us momentum. A huge THANK YOU to everyone who shares information about fluoroquinolone toxicity with their social network!

While it is sad to see the devastation that fluoroquinolones bring to every floxed individual, it is nice to see that the awareness of fluoroquinolone toxicity is reaching people, and that they are reaching out for support on facebook. The community of floxies helping and supporting each other in The Fluoroquinolone Toxicity Group has grown significantly. Each person who connects their health problems to fluoroquinolones is a step toward general awareness of fluoroquinolone toxicity. Everyone who joins The Fluoroquinolone Toxicity Group realizes the dangers of fluoroquinolones for themselves and their loved ones. Of course, I hate to hear of people getting hurt by fluoroquinolones, but with each new member to the group, awareness and support are gained.

Even this site has gained a lot of momentum. When it launched in 2013, Floxie Hope was getting about 5,000 visitors per month (which I was THRILLED with). Now 30,000+ visitors per month view Floxie Hope. I’m proud to be part of the movement toward awareness of the devastation that fluoroquinolones bring, and I hope to be part of movements to study fluoroquinolones and limit their use.

All of us who are telling our stories, supporting each other, and sharing information about fluoroquinolone toxicity are making progress. Thank you to all of you!

Admittedly, we have a long way to go before paradigms about the safety of fluoroquinolones shift in the general population.  There are still some doctors who are giving FQs out like candy.  There are still people who deny adverse effects of fluoroquinolones that are listed on the warning labels.  There is still a lot of research that needs to be done.  But progress has been made in the last year, and this post is to celebrate that progress.  Good job, friends!  Keep going!

 

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The Floxie Hope Podcast Episode 3 – Rachel Brummert

RachelQVF

Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, is interviewed on Episode 3 of The Floxie Hope Podcast.  Rachel goes over her history with fluoroquinolone toxicity; and gives information on the history, mission and activities of the Quinolone Vigilance Foundation (QVF).

The QVF is engaged in research, advocacy, outreach and other activities related to helping victims of fluoroquinolone toxicity.  The Mission of the QVF is to understand and reduce Quinolone/Fluoroquinolone Toxicity as a cause of human suffering in the world.

Per the QVF’s web site, www.saferpills.org, they fulfill this mission by networking medical professionals and researchers; fostering, initiating, and directing fundamental research to discover underlying toxicity mechanisms; funding research that will produce the most promising results; translating new discoveries into effective medical practices, therapies and public health approaches; and develop and applying discovered knowledge to educate the medical community and help alleviate individual suffering.

You can learn more about the QVF through listening to Episode 3 of The Floxie Hope Podcast.  It is available through the following links:

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

Floxie Hope Podcast Web Site – http://www.floxiehopepodcast.com/floxie-hope-podcast-episode-003-rachel-brummert/

Thank you for listening!

Please share The Floxie Hope Podcast with your loved ones and help us to get the word out about the dangers of fluoroquinolones.  Thank you!

All reviews of The Floxie Hope Podcast on iTunes are appreciated!

Enjoy!

 

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Petitioning the FDA – Comments Needed

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

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

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

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

Thank you!

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

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

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

Possible Mitochondrial Toxicity

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

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

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

WARNING: POSSIBLE MITOCHONDRIAL TOXICITY

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

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

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

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

THANK YOU!

 

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I HOPE for Change

This site was started to give hope for healing to those suffering from fluoroquinolone toxicity. Stories of healing and recovery are shared on www.floxiehope.com so that the people who are going through the destruction done by fluoroquinolones that we refer to as “floxing” (as one Floxie noted, it’s cuter than calling it disability brought on by a chemotherapeutic drugs masquerading as antibiotics) can see that others have recovered – and so that they can learn lessons from those who have gone through fluoroquinolone toxicity and healed.

More than the lessons and techniques used for recovery though, I think that the important thing that the stories convey is hope – hope that recovery is possible. Recovery happened for the people who have shared their stories on floxie hope – so there is reason to hope that you will recover too. Sarah, Bill, Crystal, Ruth, Sharon, Brian, Keri and all of the other people who have shared their stories on floxiehope have recovered. If they can do it, so can you. There is hope in knowing that other people have emerged from this horrible toxicity syndrome. And HOPE, I believe, is healing. It helps to believe that there is a light at the end of this tunnel. It helps to know that it’s possible for the spiral of ill-health, and new, scary symptoms, to come to an end; and that recovery and a return to health is possible.

None of the effects of fluoroquinolones on the body or brain are “in your head” or a choice, but, with that said, the mind is a powerful thing. Having hope, and faith that this will pass, and that your health will improve, is important and powerful. HOPE is healing.

In many of the posts on this site, and articles linked to through this site, I have strayed from a message of hope for healing/recovery. I have posted essays that are angry, fearful, questioning and/or accusing, not hopeful. Some of these posts/essays have scared many of you. Some of them have probably pissed you off. Some of them have probably made you feel less hopeful about the prospects for your future health.

Understandably, I have gotten push-back from people in response to those posts. People have said, “I thought this site was supposed to be about HOPE, not ____” (fill in the blank with any scary, intimidating fluoroquinolone related topic). I’ve been thinking about the sentiment that they have expressed a lot lately, and these are my thoughts:

First, I’m sorry. I’m sorry for inducing fear and/or pissing you off. The fact that fluoroquinolones do really horrible things to cells, and that I am really angry at Bayer, J&J, the FDA, doctors, pharmacists and everyone else responsible for this mess, does not detract in any way from the fact that people can, and do, recover from fluoroquinolone toxicity. If it’s helpful, please skip my downer posts and just read the stories on this site. The stories are reason for optimism and hope. They are stories of perseverance, strength, optimism through adversity and healing. They are meant to convey HOPE for healing.

Second – I’m going to defend myself a bit – I think that the scary and/or intimidating topics are hopeful – they’re just hopeful in a different way. They’re not about hope for healing or recovery, but they are about hope for other things – like information, justice, answers, and stopping this insane system that allows mineral chelating, mitochondria destroying, multi-symptom chronic illness inducing chemicals to be given to people to treat urinary tract infections.

The way that things are now is not okay. Systems are broken and people are getting hurt by those broken systems.

I HOPE that the absurdity of people needlessly being hurt by fluoroquinolones is realized – by everyone.

I HOPE that doctors start realizing that the people who come into their offices with multi-symptom, chronic, mysterious ailments after a course of fluoroquinolone antibiotics are suffering from fluoroquinolone toxicity. I HOPE that they realize that these reactions are not as rare as they have been led to believe. I HOPE that they think twice about prescribing fluoroquinolones again after they recognize fluoroquinolone toxicity in their patients. I HOPE that the information on this, and other FQ toxicity related sites, gives them the information that they need to see that fluoroquinolones are dangerous drugs.

I HOPE that people gain information from this site with which they can become empowered. I HOPE that the articles and posts on here give you the information that you need to understand what is going on in your body. I HOPE that you are able to take the information that you gather from this site and share it with your doctors, friends, family, etc. I HOPE that they are able to gain understanding of what you are going through from reading about fluoroquinolone toxicity.

I HOPE that the FDA quits being inept and more tightly regulates fluoroquinolones and other dangerous drugs.

I HOPE that we all gain answers to the question of, What in the world is going on in my floxed body??? I HOPE that I (or other people) am able to gather up the articles and information that is necessary to answer that question. And, with that information, I HOPE that a protocol is established that helps people to heal from fluoroquinolone toxicity.

I HOPE that we all gain justice. I HOPE that Baron & Budd, or any other law firm that brings a suit against Bayer and Johnson & Johnson for the damage that their drugs have done to people, wins and that all victims of fluoroquinolones are adequately compensated for their pain and suffering. I HOPE that the lawyers generally stop pussy-footing around with lawsuits for individual symptoms and start bringing lawsuits against FQ producing corporations for inducing multi-symptom, chronic illness in victims. Because that’s the truth – it’s what’s happening. I HOPE that the top executives and scientists at the corrupt pharmaceutical and big-ag companies that are poisoining us all are charged with, and found guilty of, crimes against humanity. I HOPE that justice is served – in every way possible.

I HOPE that all of the people and institutions that are supposed to be keeping the pharmaceutical industry in check (the FDA, the media, the justice system, conscientious doctors, etc.) – who are currently failing – start DOING THEIR JOBS.

And of course, still, I HOPE for your healing. I HOPE for your recovery. And I HOPE for the continued wellness of those who have healed.

This site is about HOPE. It’s about HOPE for change in just about every area to do with fluoroquinolone toxicity. It’s about HOPE for individual change – mainly the healing kind. And it’s about HOPE for institutional change. I HOPE it comes soon – because too many people are getting hurt by cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin and floxin/ofloxacin. It’s not okay. It needs to change. I HOPE it changes.

 

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