Manufacturers of fluoroquinolone antibiotics must update their labeling to warn about mental health issues and potential low blood sugar adverse reactions, the FDA said Tuesday.
The labeling changes come after what the agency described as a "comprehensive review of the FDA's adverse event reports and case reports published in the medical literature," the agency said in a .
The FDA stated that these will be class-wide updates, where they previously differed by individual drug. Mental health side effects will now be listed separately and labeled "consistently." They are set to include "disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium." However, the new warnings won't come with the black border signifying the most serious types of risks.
A warning about nerve damage, specifically peripheral neuropathy, associated with the use of fluoroquinolone antibiotics was previously added in 2013.
Fluoroquinolone antibiotics will also require a separate warning about the risk of hypoglycemic coma added to the Blood Glucose Labeling Subsection, the agency said, citing "instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia."
However, the FDA said that healthcare providers and patients should continue to "consider the risks and benefits" of fluoroquinolone antibiotics in treatment.
"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, FDA director of the Office of Antimicrobial Products, in a statement.
Fluoroquinolone antibiotics include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela), as well as more than 60 generic versions. This revised warning applies to forms of the drug taken by mouth or given by injection, the FDA said.
This is the latest in a series of escalating warnings about the safety of fluoroquinolones that date back to 2008. The latest came in 2016, when the FDA required a warning about potentially permanent musculoskeletal complications associated with the use of these drugs.