FDA ruling on Quinolones! FINALLY!!!

The FDA MADE A DECISION!

I have been working on this for almost 2 years! Some great news to share with quinolone sufferers: Finally! The FDA made a decision after almost 2 years since my original citizen petition was filed against quinolones (as did many other people’s petitions against this) class to put a warning on the label and NOT recommend the use of any of the drugs in that class for simple diseases like UTI, sinus infection and alike.

I received a response from them about a year ago that you can read here stating that they were “unable to decide“… whatever that means. Glad they finally were able to decide! It is about time!

The drugs in this class are:

  • ciprofloxacin (CIPRO, CILOXAN)
  • enoxacin (PENETREX)
  • levofloxacin (LEVAQUIN)
  • moxifloxacin (AVELOX)
  • norfloxacin (NOROXIN, CHIBROXIN)
  • ofloxacin(FLOXIN, OCUFLOX)

Please REFUSE any of these in the future since doctors like to override FDA regulations! I personally have these drugs on my “allergic to” list. I recommend you do the same.

Here is the FDA message:

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.

BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and

Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and previous MedWatch alerts here.

The fight is not over yet; there is much more to do. But step 1 is mission accomplished! Now that the FDA admitted that there is a problem, research toward helping the injured can go on!

Questions are welcomed, as always!

Angela

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About Angela A Stanton, Ph.D.

Angela A Stanton, PhD, is a Neuroeconomist focusing on chronic pain, electrolyte homeostasis, and genetics. She lives in Southern California. Her current research is focused on migraine cause, prevention and treatment without the use of medicines. As a forever migraineur from childhood, her discovery was helped by experimenting on herself. She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic variations of all voltage gated channels that modulate electrolytes and voltage in the brain, insulin and glucose transporters, and several other related variants, such as the MTHFR variants of the B vitamin methylation process and many others. Migraineurs are glucose sensitive and should avoid eating carbs as much as possible. As a result of the success of the first edition of her book and new research and findings after treating over 4000 migraineurs world wide, all ages and both genders, she is now finishing the 2nd edition. The 2nd edition is the “holy grail” of migraines, incorporating all there is to know and also hypotheses. It includes an academic research section with suggestions for further research. The book is full of citations to authenticate the statements she makes to be followed up by those interested and to spark further research interest. It is a "Complete Guide". Due out in the summer of 2017. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in NeuroEconomics at Claremont Graduate University, and fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers. For relaxation Dr. Stanton paints and photographs. Follow her on Twitter at: @MigraineBook
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15 Responses to FDA ruling on Quinolones! FINALLY!!!

  1. Lyman Duggan says:

    http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

    Former FDA Commissioner Charged in RICO Lawsuit
    A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.

    Liked by 1 person

  2. Chris Butler says:

    I had a role in this decision. One of my cases was one that was included in the study as well as my written testimony to the FDA on this issue. Like most, I was given Levaquin and Avelox, almost always with prednisone (contraindicated). A small but significant victory for us floxies. I won’t put the entire history here, but these drugs caused 7 tendon tears, permanent neurological damage, ulcerative colitis and so much more. I continue to work to get change made at the FDA. They aren’t protecting the consumer, they’re protecting the corporation’s. Until we can get congress to stop pandering to their constituents, I don’t see this agency or the USDA changing anytime soon. Even Obama managed to appoint a director that has significant ties to Big Pharma. That really disappointed me. However, it goes to show, irregardless of political party, our elected officials are being corrupted by corporations.
    Just an FYI, to get better, I switched to organics over 4 years ago. It was instrumental in helping me put the colitis in remission (now to keep it there).
    Also, I have a friend that kept suffering from migraines. The first thing the holistic doctors did is get her off processed foods, gluten and dairy. Guess what, the migraines have subsided. Gives some credence to a clean diet being the best diet. With the exception of fighting the neurological damage, I rarely have any health problems at 55. It works, just wish more people would wise up and realize these corporations are poisoning us.

    Liked by 1 person

    • Be Healthy says:

      Hi Chris,

      As part of The Quinolone Vigilance Foundation, your help is as greatly valued as is the help of everyone else about getting these drugs to at least start to be removed from common use like I did (please give my best to Rachel Brummert… lol). I found that while the FDA makes regulations, doctors prefer to ignore them so I recommend you print out the FDA update every time you visit a doctor and push it under their noses. I have it on my phone (as I do with the epidural corticosteroids being off-label and not authorized by the FDA) and I have the doctor I visit read them. It is amazing how ignorant they are and also obnoxious about their knowledge over FDA regulation (as in recommending Aspirin, for example, for women to take as first line cardiac event prevention even though Aspirin is not permitted to be recommended as first line cardiac event prevention for any gender and for women it does not even work for the heart; it only works for ischemic stroke (blood clot type) but only if she already had one). The FDA denied Bayer the right to claim that Aspirin can be recommended for first line prevention and wrote also a long explanation for what it can or cannot be recommended for use.

      Many doctors are amazingly ignorant and downright “clueless” hence the name of my blog. The same with the Quinolone antibiotics. Although the FDA has addressed the issue requiring providers to change, they ignore it completely. Since this update came out from the FDA, several people have contacted me that their doctors prescribed Cipro, for example, and what should they do? One patient was about to get Cipro as IV that she refused so the doctor wrote a prescription for Cipro and she did not notice it was Cipro until she took it home. Her hubby had to get to the ER on Sunday to have them replace with a non-quinolone antibiotics.

      I am very sorry about your injuries. I am also having trouble with tendons–tor one of my Achilles and feel the pain for both when walking but I found a few things that help. I don’t visit holistic doctors since by definition they are not doctors (it is actually illegal for them to call themselves doctors since they are not educated in human health and body at all). However, I have done my research on diet and since I am also a migraineur see my book here) and my program for migraine treatment and prevention here, I am now also creating a special nutritional approach that is migraine proof AND can repopulate our damaged mitochondria with new ones with healthy DNA. It requires much more than unprocessed foods and also gluten free is not enough, it needs to be grain free, sugar free, sugar substitutes free, rich in animal saturated fats, whole milk, with zero starchy vegetables and minimal on fruits with zero tropical fruits.

      There is more to it than this but this is a good introduction to the approach. I am older than you and also am never sick. There is a definite benefit to dumping all the junk out of your diet and keeping to wholesome healthy foods whatever they come with–including tons of fat!

      Best of luck to you,
      Angela

      Like

  3. ann says:

    the doc. just gave me this. was on it for 3 days and my joints started hurting. had to go off and he gave me anther drug.

    Liked by 1 person

    • Be Healthy says:

      I am glad Ann that you discovered it in time. Hopefully all problems will be gone and not much damage was done. If it was brand name, hold onto the bottle!!!! You will need that for the lawsuits that are surely going to follow soon!

      Angela

      Like

  4. T.J. says:

    8 days of cipro two years ago stole my life. No warning. I should have been given a different choice. This updated FDA warning was long overdue. It came too late for me but will prevent more suffering. I can bareky walk. This is 2 years of pain. Others have been suffering for 18 years……those who didnt die

    Liked by 1 person

    • Be Healthy says:

      I am very sorry to hear T.J. that is also harmed you. There have been suicides as well. It is a grim scene now but I recommend 2 things for you: 1) there are several law suits that are popping up. Join one. 2) There are some things you can do to improve your condition. I am now spending a tremendous time understanding mitochondria and the damage that can be caused to them by anything, including damage to them by drugs that modify their DNA. Since I do not wish to help Big Pharma in their research efforts toward a gtreatment and cure but since I have been doing a lot of work toward it that seems to work, please join the new group I just formed this moment on Facebook called “Floxed“. It is a closed group and will be used to brain storm by those affected and by scientists like me and others to come to a solution bypassing big pharma if possible.

      Best wishes,
      Angela

      Like

  5. Roald Michel says:

    No questions. Just a simple, but cautious, congratulation.

    Liked by 1 person

    • Be Healthy says:

      Why cautious? 🙂 Open a bubbly! Celebrate! So many people’s lives will be saved!

      Like

      • Roald Michel says:

        “So many people’s lives will be saved!”? Only a delicious optimist like yourself will believe that. Do you really think those morons will read that stuff, and/or act against what their guru doc will tell them to do? And the rest of “us” were saved a long time ago already, because “we” didn’t need the FDA authority, for “us” to discontinue using that crappy stuff. “We” only needed you 😛

        Like

        • Be Healthy says:

          Heh, true. I did send the FDA link of this decision to my doc. 😉 Not to be rude… but heck READ THE STUFF I said.. so there… Many people now, I am sure, are gearing up for lawsuits–I too was hurt by these drugs by tearing my Achilles tendon, luckily only a partial tear but a tear and it is quite permanent… So when and if the time comes, I will hope to be part of it. I think that this FDA decision will have a lot father reaching effects than it seems up front.

          Admitting that these drugs cause permanent damage by the FDA and that they will now re-label all of these drugs means that big pharma can start workign on a solution to a problem that was now officially introduced–out of under the rug so to speak. So basically this provides a new responsibility to big pharma to fix the problem and find a treatment to those hurt and an opportunity to all who were hurt to file their lawsuits. And hopefully new people will not be added to the list of hurt!!! I try my best to pass information on but I am only one person.

          But yeah, those who listen, they have me.. several thousand luckily… should be millions the way I see it! (It may be with twitter already!)

          Like

          • Roald Michel says:

            “……but I am only one person.” Oh, but I’m spreading the word too. Yeah. like a true messiah I sent, and will send, your stuff to medicine men and other members of the ever increasing herds. And I won’t even mention folks I brainwash face to face with that stuff, creating new herds “as we speak” 😎

            Liked by 1 person

            • Be Healthy says:

              Thank you my friend! That is super! ❤ Eventually the grassroots movement will outgrow its roots! 😉 Lot more coming up. I am finishing the 2nd ed of my book and also working on an article about cholesterol and then later one about mitochondria (I know those pesky little things no one knows our lives depend upon). 😉 Have you seen my articles here: https://www.hormonesmatter.com/author/angela-stanton/ ? One started a salt world war and some others, like on Topamax and SSRIs (Silent death, which is about my mom actually) have gone viral big bang argued all over. People are stopping Topamax and SSRIs like never before. 😀 I like that blog (it is not mine, I am a scientist author there). My cholesterol article will show up there and will put the world into a spin it will not recover from easily. 😀

              Like

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