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.
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!
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.
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.
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
Can’t help wondering if drug reps will have to change their spiel, or if it will just be business as usual.
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.
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.
I was on synthyroid when I first found out my thyroid was bad. Then when they went to generic levothyroxine my symptoms came back with brutal force. When I was switched it was fine but I guess with different manufactures the compound was changed a little. I have found I can’t take generic drugs. Now my doctor has to sign a form telling the pharmacy to give me the real synthyroid and nothing else. Government law now. My go to drug for Lyme disease was Metronidazole (Flagel) and my nerve doctor just told me that was probably what has given me neuorothy along with tendon and muscle damage. I also took Cipro so I am screwed for the rest of my life. Thank goodness I am not a depressive person but it’s a struggle dealing with it every day.
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