FDA Denies Petition Seeking Levaquin Mitochondrial Toxicity Labeling

In issuing a 5/12 drug safety communication on fluoroquinolones when they are used systemically, the agency also simultaneously denied a 2014 petition seeking to change the professional labeling for Johnson & Johnson’s Levaquin (levofloxacin) to warn about possible mitochondrial toxicity. The petition denial letter says that an agency pharmacovigilance review found mitochondrial toxicity was included as a possible explanation for the association between systemic fluoroquinolone drugs and the development of peripheral neuropathy. However, it says, 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.” The petition was submitted by the Southern Network on Adverse Reactions.