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 requiring 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 the 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.“
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.