Más cuidado con las Fluoroquinolonas.

FDA Issues Stronger Fluoroquinolone Warnings About Hypoglycemia, Mental Health Issues

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

The FDA is calling for label changes to fluoroquinolones (e.g., ciprofloxacin, levofloxacin) to strengthen the warnings that the antibiotics could cause severe hypoglycemia or mental health issues. The new requirements are based on an agency review of adverse event and case reports.

The subsection on all systemic fluoroquinolone labels about blood glucose disturbances must now explicitly warn of the potential risk for coma due to hypoglycemia. Mental health side effects — which include agitation, attention disturbances, delirium, disorientation, memory impairment, and nervousness — must now be listed separately from adverse reactions to the central nervous system. In addition, they must be consistent across the entire class of drugs. Mental health side effects have been reported after just one dose.

Fluoroquinolone labels already include numerous warnings, including boxed warnings about risks for tendinitis and tendon rupture, as well as worsening muscle weakness in patients with myasthenia gravis.

FDA MedWatch safety alert (Free)

FDA news release (Free)

Background: Physician's First Watch coverage of 2016 restrictions on fluoroquinolone use (Free)

Benjamin Hidalgo-Matlock

Skin Care Physicians of Costa Rica

4000-1054

2101-9574

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