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

Fluoroquinolone Community Goes to the FDA: Pediatrics and Rhabdomyolysis

On August 24th, 2015, members from the FQ community met with staff from the FDA in a third meeting to address the various FDA failures to adequately warn the general public about the true dangers FQ's pose to the general public, especially our children.

Yet Another FDA Failure: PatientsLikeMe®

Why would the FDA make such an outrageous decision to enter into an unprecedented agreement to monitor post-marketing drug surveillance with a private company run by ex-pharmaceutical executives? The FDA would be better off looking at its FAERS data. If they did, they would see drug signals that they have ignored, especially for FQ's.