FDA Announces Labeling Changes for Fluoroquinolones Due to Mental Health AEs, Blood Sugar Disturbances

The US Food and Drug Administration (FDA) has announced required labeling changes for fluoroquinolones, a class of antibiotics used to treat serious bacterial infections, to strengthen the warnings related to the risk of mental health adverse events (AEs) and blood sugar disturbances.

The label changes must be consistent across all forms of the antibiotics, oral or injection, according to the agency. Currently, FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). Overall, more than 60 generics have been approved.

The changes being required were based on “a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature,” according to the agency.

“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 the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.”

Currently, a wide range of mental health AEs are already included in the labels but differ by individual therapy. The changes require that the mental health AEs are listed separately from the other central nervous system (CNS) AEs. All in all, the mental health AEs include disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

With regard to the blood sugar effects, the FDA reported instances of hypoglycemic coma in cases where patients on fluoroquinolones experienced hypoglycemia. As such, the Blood Glucose Disturbances subsection of the labels for fluoroquinolones will be required to plainly reveal the potential risk of coma with hypoglycemia.

Previously, in 2016, the FDA announced it was enhancing the warnings about the association between the antibiotic class and potentially permanent AEs involving tendons, muscles, joints, nerves and the CNS. “Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options,” the agency noted.