Another Milestone Crossed: Fluoroquinolones, The FDA, and Psychiatric Adverse Events

In an astonishing statement from the FDA, they acknowledged that since “Psychiatric Effects” will specifically be identified within the “Central Nervous System Effects” subheading, psychiatric adverse events are automatically assumed to be part of the existing Black Box warning.

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 and issued a public statement that the FDA is requiring label changes for antibacterial drugs called fluoroquinolones