FDA updates warnings for fluoroquinolone antibiotics
FDA announced Tuesday that it is ordering labeling changes for fluoroquinolone antibiotics to strengthen warnings about the risks of mental health adverse effects and serious blood sugar disturbances.
FDA announced Tuesday that it is ordering labeling changes for fluoroquinolone antibiotics to strengthen warnings about the risks of mental health adverse effects and serious blood sugar disturbances. According to the agency, the changes also aim to make the warnings more consistent across labeling for all fluoroquinolones that are taken orally or injected. "The use of fluoroquinolones has a place in the treatment of serious bacterial infections—such as certain types of bacterial pneumonia—where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option," said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. The labeling changes, which follow a comprehensive review of FDA's adverse event reports and case reports in medical literature, seek to help providers and patients consider the risks and benefits of fluoroquinolones, Cox said. Within the class of fluoroquinolone antibiotics, various mental health adverse effects are already listed in the Warnings and Precautions section of the drug labeling; however, they varied by individual drug. Under the new class-wide labeling changes, the mental health effects must be listed separately from other central nervous system adverse effects and be consistent across the labeling for the class. The mental health adverse effects to be included in the class-wide labeling are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. The Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones must also explicitly reflect the potential risk of coma with hypoglycemia. FDA also issued on Tuesday a <a href="https://www.fda.gov/Drugs/DrugSafety/ucm611032.htm" target="_blank">drug safety communication</a> about safety information regarding hypoglycemic coma and mental health adverse effects with fluoroquinolones.