FDA calls for stronger warnings on fluoroquinolone antibiotics

With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

The low blood sugar levels can result in serious problems, including coma, particularly in older people and patients with diabetes who are taking medicines to reduce blood sugar. The FDA is making these changes because its recent review found reports of life-threatening low blood sugar side effects and reports of additional mental health side effects.

The label changes, which follow a series of warning additions over 10 years for these antibiotics, are also meant to make the warnings consistent whether the drugs are taken by mouth or injected. "