FDA Strengthens Warnings on Certain Antibiotics

The FDA has called for label changes to fluoroquinolones in order to strengthen warnings of potential severe hypoglycemia or mental health issues that could occur when taking the antibiotics.

Most fluoroquinolones, which have been used for more than 30 years for the treatment of certain serious bacterial infections, include labels warning of blood sugar disturbances and mental health side effects depending on the fluoroquinolone class.

The new label changes add warnings that low blood sugar levels could lead to coma and will make the section on mental health side effects more prominent and consistent across the fluoroquinolone drug class. The mental health side effects to be added include:

• disturbances in attention
• disorientation
• agitation
• nervousness
• memory impairment
• serious disturbances in mental abilities called delirium.

“FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.”

—Michael Potts

Reference:

Fluoroquinolone antibiotics: FDA requires labeling changes due to low blood sugar levels and mental health side effects [press release]. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm.