FDA Changes Fluoroquinolone Label But Denies Citizen Petition on Mitochondrial Toxicity

On Thursday May 12, 2016 the FDA contacted those who have been pursuing label changes for the Fluoroquinolones in addition to issuing a public statement that the FDA is requiringFDA-01-620x400 label changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning and Medication Guide, and advising that the serious side effects associated with fluoroquinolones 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 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, the FDA is requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.

For more information, please see http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm.

Although this is a step in the right direction, at the same time the FDA has denied Dr. Bennet’s Citizen Petition on mitochondrial toxicity.  In a statement outlining theThumbs_Down reason for the petition denial that FDA stated “The literature discussed in the Review, which is based primarily on animal data and in vitro data, provides insufficient support for the proposition that levofloxacin causes mitochondrial toxicity, and that this toxicity results in levofloxacin-induced peripheral neuropathy.

https://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0856-0011

Again, while the labeling changes are a step in the right direction, it is imperative that we, as a community, continue to pressure the FDA for further changes to fluoroquinolone labeling especially for mitochondrial toxicity.

Admin

...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

4 Responses

  1. Dillie Meeks-Alexander says:

    I was prescribed generic 10 day regimen of Levaquin in February 2012 for bronchitis infection. I have been going downhill ever since in terms of achilles tendons, nerves, feet/ankles/calves/balance issues (probably due to muscle wasting). Pain is constant and daily now. I just discovered within the last 30 days that what is going on with me is due more than likely to my being “floxed” 4 years ago. It is ironic that this issue is 20-30 years in the making. I’m hoping that as the word gets out, more people will come forward and we can halt the marketing of these insidious drugs.

  2. Mark A Girard says:

    Thanks David, it sucks they did not include mito damage but it is a step in the right direction. We just have to keep pounding them from every angle we can! Keep up the good work my friend! Mark

  3. Wayne says:

    It is nice to have a victory with labeling. But in my opinion the FDA is giving us something on one hand, and taking something away that will make it harder for us in the long run, on the other hand.

  4. Julie says:

    That’s crap. The whole way I had to prove to my primary care that I might know what I was talking about. Was to find a test that showed my mom that mitochondrial DNA damage. I snuck the orders into his assistant. Once they came back and showed how about I have mitochondrial DNA damage then he really couldn’t deny anymore. There would be no other reason but that’s what would show. That is what made him start studying this reaction. I can’t understand why they will come clean on some and keep hiding more. It makes me so so angry. My God FDA you made a major freaking mistake top to bottom side to side inside out. Admit it all and figure out what you need to do to help fix us. Or at least get us to the point that we can live a life again

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