FDA Advises Restricting Fluoroquinolone Use

May 12 flox victory

On May 12, 2016 the FDA released the announcement, Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections. It stated:

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.

This is huge, wonderful news for the “floxie” community!

The middle paragraph of the FDA announcement is particularly gratifying. The FDA is acknowledging that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin) are associated with “disabling and potentially permanent serious side effects that can occur together.” They are acknowledging that fluoroquinolones can lead to multi-symptom chronic illness, and that’s HUGE! Fluoroquinolones don’t only cause one or two of the side-effects listed on the warning label in isolation, they cause a syndrome of illness. For the FDA to acknowledge this is an enormous step in the right direction. (More on the FDA’s acknowledgement of Fluoroquinolone Associated Disability, FQAD, can be found in the post, “An Official Name: Fluoroquinolone-Associated Disability (FQAD).”)

This acknowledgment from the FDA grew out of thousands of people reporting their symptoms to the FDA, speaking out to the media, and testifying before the FDA.

The change in fluoroquinolone warning labels stemmed from the November 5, 2015 meeting of the FDA’s Antimicrobial Drugs Advisory Committee meeting to discuss, “the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.” Hundreds of victims of fluoroquinolones, as well as doctors, attorneys, journalists, and other supporters, attended the Antimicrobial Drugs Advisory Committee meeting, where 30+ people were able to tell their story of how fluoroquinolones had devastated them and their loved ones–causing multi-symptom, chronic illness that resulted in disability and even death for many. The transcript from the meeting can be found HERE. The committee listened, and ruled that the current warning labels on fluoroquinolones were not sufficient, and that fluoroquinolones are not appropriate for use in treating minor infections.

fluoroquinolone-lawsuit-banner-trulaw

Because the FDA has a history of not doing as their committees request, and because action can take years, those in the fluoroquinolone injured community weren’t sure whether or not the victorious ruling at the committee level would translate into changes to the actual warning labels. However, on May 12, 2016 the FDA made the announcement that the warning labels for fluoroquinolones would change to note that the risks of fluoroquinolones outweigh their benefits in the treatment of patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. The announcement, and the ensuing warning label changes, mark a moment of victory and vindication for victims of fluoroquinolones

Though many people don’t think that changing the warning labels is enough (and they have very good, legitimate reasons for thinking that warning label changes are inadequate), it is a step in the right direction. With warning label changes, perhaps doctors will acknowledge fluoroquinolone toxicity and restrict their use of fluoroquinolones. Additionally, warning label changes open doors for lawsuits, and lawsuits have the power to hurt the pharmaceutical companies and help victims of fluoroquinolones to gain justice. If the warning label changes include language like, “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.” the door will be open for many floxies with many symptoms to sue Bayer and Johnson & Johnson, the makers of Cipro, Levaquin and Avelox. Lawsuits, if successful, may bring about change in the distribution of fluoroquinolones, and may also help victims of fluoroquinolones to gain justice and possibly even healing.

The FDA announcement has also led to media coverage, and with media coverage comes additional awareness. The word is spreading far and wide as to how dangerous these drugs are.

The FDA announcement is a massive step in the right direction, and May 12, 2016 is a very good, victorious, vindicating day for victims of fluoroquinolones. It is a day to celebrate!

Cheers, my friends!

great-gatsby-dicaprio-cheers

Cheers!

 

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26 thoughts on “FDA Advises Restricting Fluoroquinolone Use

  1. L May 13, 2016 at 10:35 am Reply

    It is a small victory, but I wish I shared your enthusiasm on this Lisa. First, I am pissed it took them six months, while I read of new victims. Second, I am afraid it will be business as usual with most doctors since they were already ignoring the Current warnings. This has no teeth. It should have been either pulled or mandated only used in instances of life and death.

  2. Lorelle May 13, 2016 at 10:57 am Reply

    The FDA is giving drug companies 30 days to comply with new wording or submit alternate wording for the FDA to approve. My worry is that docs and pharmacists will not read the new wording or the detailed warnings.

    • L May 13, 2016 at 12:17 pm Reply

      My sentiments exactly, Lorelle. Mine didn’t read the black box warning and gave it to me with prednisone, and I am willing to bet that NO ONE on this site was warning about possible permanent nerve damage. Just more placating big pharma.

      • Lisa May 13, 2016 at 3:25 pm Reply

        I hear you both, and I largely agree. I don’t think that warning labels are a good communication tool, and I know that they are largely ignored. I think that the change will happen within the legal system. Every time the warning labels change, the door is opened for lawsuits. If Bayer and J&J are repeatedly sued, maybe they’ll take these horrible drugs off the market. It’s possible too, that at least some of the doctors will hear about the revised warning labels, and that some people will be spared the horror of FQ toxicity. I hope so.

        • L May 13, 2016 at 3:48 pm

          I would love to see the FDA held accountable as well. They have been miserable at protecting.

  3. Lin Stevens May 13, 2016 at 11:32 am Reply

    Great news. RE: 5-12-16 “FDA Advises Restricting Fluoroquinolone Use”

    I forwarded this to all my contacts. I have taken Cipro 5-6 times in the 90’s. Was very sick after those doses , but was diagnosed as Hashi thyroid and severe Fibromyalgia (feel now in error….Cipro caused all). Took it 3 times since 2008. In 11/2012, I took a dose for a UTI, had a colonoscopy couple weeks later and a Mammo.

    I had a complete breakdown in 1/13. Lost 15 pounds in few weeks, total unrelenting insomnia, HBP during the night, circadian (SP?) rythmn irregularity, total anxiety, change of personality, crying falling apart, feel like I’m dying. Buzzing like cell phone in my toes, numbness, dizzy. etc. etc. Pulled heart area. Very painful left side of neck and left cheek and jaw. Lot of pain in the coccyx area. Felt (still do when tired) like falling forward ….head too heavy for neck to hold up. Numbness, weakness. foggy.
    Went to many different doctors, PT, Therapists…including neurologist at NYU Langone Clinic , NYC. ..Reassured me but no diagnosis.

    I’m a special education teacher (I was now special education) unable to read or drive. Eyes and ears weird…..felt couldn’t close my ears to rest, sounds so loud (Magnesium?) blurred and double vision, detachments, floaters, vitreous tears. Also realize I had milder versions of these symptoms with prior taking of Cipro. I am not working…..symptoms always there but come and go with less intensity.

    Burning forehead and eyes still very annoying, Immune system poor. Last year at 65 years of age I had strep throat for the first time in my life. Right now I have a bad cold that is very intense and can’ t get rid of it. Seems my mucus membranes have changed……don’t think they are working right. My lips , especially the collagen in my bottom lip is flabby and swollen on the inside. Very poor short term memory, numbness

    Is there a class action suit? Should I be contacting or advocating to someone? I feel the need to have someone direct me and hear my story. Happy things are moving forward for all of us.

    Also….is there probiotic that has been found to help. Feel like need Leaky Gut Help. Have had ingoing MSG sensitivity for year. Thank You……….. Lin Stevs

    • Lisa May 13, 2016 at 3:30 pm Reply

      Hi Lin,

      I’m so sorry for everything you’ve been through! I have a couple sites I’d like to refer you to. First, I highly recommend that you read this post – https://www.hormonesmatter.com/fluoroquinolone-antibiotics-thyroid-problems-connection/. The author of that post also has a wonderful web site – http://fluoroquinolonethyroid.com/. Both contain a fantastic amount of information about fluoroquinolones and how they affect the endocrine system.

      As far as lawsuits, there are some firms that are currently taking cases. They are listed on https://floxiehope.com/fluoroquinolones-links-resources/. Right now, those firms are taking cases for people suffering from peripheral neuropathy from taking FQs. I anticipate that the new announcement will prompt more lawsuits as well.

      Regards,
      Lisa

      • Lin Stevens May 14, 2016 at 7:49 am Reply

        Thank you, Lisa. Will look into your suggestions. Greatly appreciate your help. I do have neuropathy….burning forehead, and face , numb (at Times ) hands and feet. Wish there was a class action suit….hopefully will be one in future. I’m too tired to pursue anything myself.

  4. Ms. A May 14, 2016 at 2:05 am Reply

    Can’t help wondering if drug reps will have to change their spiel, or if it will just be business as usual.

    • L May 14, 2016 at 9:31 am Reply

      I was wondering the same thing, since apparently most doctors never seem to get the message about warnings. (They need to spend more time on social media, since the networks don’t dare upset their ad revenue.)

  5. […] (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). (more info here, here, here and here), […]

  6. […] drug safety advocates realize that this change is only one small step in the right direction, and that much more needs to be done to prevent people from suffering from disabling […]

  7. […] drug safety advocates realize that this change is only one small step in the right direction, and that much more needs to be done to prevent people from suffering from disabling […]

  8. Erin July 2, 2016 at 8:53 pm Reply

    I was given cipro 2 days after this warning was released for a uti. I didnt even know there was a black box warning, i even called the pharmacist and asked if my feet were hurting because of the cipro and he said no, the pain would be in my achilles tendon. (Now there is pain in both) No doctors think it was the cipro that hurt me. Im also underage, and the warning label online says not to be given to people under 18. My mom thinks we should get in contact with a lawyer but after evrything I’ve heard from other people, people who experienced worse stuff than me, a lawsuit is worthless.

    • L July 2, 2016 at 10:04 pm Reply

      That’s awful Erin. I have talked to a few doctors who know NOTHING about the latest warning. What good is that?? As for a lawsuit, did you take generic or brand name. Up until recently you could not sue the mfr if it was generic, but a couple different attorneys are tackling those cases. The problem with class action suits is they take a LONG time and the big winners are the attorneys. As for suing the doctor and or pharmacy, that is certainly a possibility. What state do you live in?

      • Erin July 2, 2016 at 10:49 pm Reply

        It really is awful how unaware the doctor’s who prescribe these dangerous drugs are, and it’s funny how the ones who are aware of what they can do will just say “it’s rare”, as if that makes the damage it does to those who are affected dismissible. I am looking at the prescription paper and the bottle of cipro and it says ciprofloxacin HCL, it doesn’t say generic for cipro so I don’t think it is generic. I’m in California. Thank you for responding 🙂

        • Erin July 2, 2016 at 10:59 pm

          I actually think the manufacturer is something called dr.reddys la .. Maybe it is generic? I also don’t think suing the mfr will work. The hospital that I went to and was prescribed cipro was shut down for malpractice or something like that a few years ago and reopened pretty recently, which is something we didn’t know until after, so maybe suing the doctor or hospital isn’t impossible considering their weird past.

        • L July 2, 2016 at 11:13 pm

          yep…dr reddy’s was mine too

        • L July 2, 2016 at 11:12 pm

          Well, actually these effects are not even rare. Dr Charles Bennett, a researcher at the U of so Carolina, using the FDAs own figures estimates that 300,000 have DIED from the fluoroquinolones, and up to a million have been injured.

          What you took is generic. I was kind of hoping you would NOT say California…that is where I am, and I can tell you the laws here really favor the hospitals and doctors. In medical malpractice cases here there is a cap on pain and suffering of $250,000, and while that may sound like a lot, attorneys can blow through that trying a case. There is also a requirement that expert witnesses be used and that can cost tens of thousands, further reducing the possible settlement amounts. For me, I was unemployed at the time and interviewing for jobs, so there was no “lost income,” which further reduces potential awards. I had several attorneys interested initially, but once they crunched the numbers, they decided against it. I actually ended up filing it myself and it has been hugely stressful, but I am not giving up. I am not an attorney ,but a paralegal so I cannot advise, but if you want to get my email address from Lisa (or ask her to give me yours) there is something I would like to share with you, if you think you may want to look into a lawsuit. Please be aware that the statute of limitations in this state for med mal is one year from date of injury (or from date you became aware of injury…)

        • L July 2, 2016 at 11:14 pm

          ok, well just read that you were given it in a hospital which changes things re a pharmacy. Still, it wouldn’t hurt to contact an attorney.

      • Erin July 3, 2016 at 6:55 pm Reply

        My e-mail is erinkennedy54@gmail.com
        (Not sure how to get in contact with Lisa lol) If you would like to talk. My mom would like to hear what you think about us getting in contact with a lawyer. Thank you. 🙂

  9. […] FDA guidelines regarding these drugs. (You can read more about the history of those guidelines here.) I have to say, I can’t help but wonder what my life would be like today had the FDA not […]

  10. Andie Goudie May 11, 2017 at 4:54 pm Reply

    I have been hypothyroid for many years and taking Levothyroine. It appears to be a steroid? Is it safe to take now that I have been floxed 5 months plus… my thyroid is acting up.

    • L May 11, 2017 at 5:17 pm Reply

      It’s not a steroid. I have been floxed and have been on levothyroxine for decades

      • Andie Goudie May 12, 2017 at 5:09 pm Reply

        Thanks, L. I have been on levothyroixne or synthroid for decades too. But now that I have been Floxed – 5 months+, thyroid is ratherhaywire along with others symptoms so I was concerned. You have not noticed any concerning changes re thyroid?

        • L May 12, 2017 at 5:34 pm

          It seemed a mess for about 8 months, but now back around normal…same dosing as before. If you are having your lab tests ordered by a regular MD you are likely not getting the full picture. An integrative MD or an Nd will ask for other indicators instead of just the standard ones.

          After being floxed I never wanted to take another pharmaceutical as long as I lived. I was hoping that would include the levothyroxine too, but it looks like I have to stay on.

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