FDA strengthens safety warnings for fluoroquinolones
The FDA is strengthening warnings about the risk for mental health side effects and serious blood sugar disturbances associated with fluoroquinolones.
The agency said it will require safety labeling changes for the whole class of antibiotics and make the warnings more consistent across all labels for both IV and oral doses.
It is the latest in a series of box warnings and safety label updates that the FDA has issued for fluoroquinolones over the past decade, including an enhanced warning in 2016 over the antibiotics’ association with tendon, muscle, joint, nerve and central nervous system
The agency said it will require safety labeling changes for the whole class of antibiotics and make the warnings more consistent across all labels for both IV and oral doses.
It is the latest in a series of box warnings and safety label updates that the FDA has issued for fluoroquinolones over the past decade, including an enhanced warning in 2016 over the antibiotics’ association with tendon, muscle, joint, nerve and central nervous system