FDA Rejects Citizen’s Petition

The FDA rejected a citizen’s petition seeking labeling changes for Levaquin to reflect psychiatric adverse events and require a risk evaluation and mitigation strategy, or REMS, among other things, according to PharmaLittle. Levaquin is a fluoroquinolone and has been the subject of previous FDA warnings about tendon ruptures, blood pressure drops, and effects on the central nervous system. Dr. Charles Bennett, a noted expert on fluoroquinolones, initiated the new warning request to the FDA. “The labeling for Levaquin has undergone numerous updates to inform prescribers and patients of the risks associated with Levaquin use,” the FDA wrote. Apparently, the FDA believes that that is enough.