FDA Updates Fluoroquinolone Labeling to Strengthen Mental Health, Hypoglycemia Risks

Officials with the FDA are requiring safety label updates for fluoroquinolone antibiotics due to risks of mental health adverse effects and blood sugar disturbances, according to a press release

The FDA stated that all fluoroquinolone antibiotics already included a range of mental health adverse effects described in the Warnings and Precautions section of the drug labeling, but have differed by individual drug.

Now, the FDA is requiring mental health adverse effects to be listed separately from the other central nervous system adverse effects, and be consistent across the labeling of all fluoroquinolone antibiotics. The mental health adverse effects to be included in the updated labeling are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.

The updates apply to the drug labels and the patient medication guides for the entire class of fluoroquinolones, which affect only the fluoroquinolone formulations taken by mouth or given by injection.

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