Tag Archives: FDA Ruling

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.

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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!

 

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