Fluoroquinolones will now require Medication Guide

July 10, 2008

Pharmacists must give out a Medication Guide when dispensing these antimicrobial drugs.

The labeling for fluoroquinolones is expected to bear a new warning shortly, according to the Food & Drug Administration. Manufacturers of this class of antibiotics must add a boxed warning about the increased risk of tendonitis and tendon rupture among treated patients. In addition, pharmacists must give out a Medication Guide when dispensing these antimicrobial drugs. FDA added that patients most susceptible to these adverse reactions are the elderly, those taking corticosteroids, and transplant recipients. The new warning would only apply to systemic fluoroquinolones, not to the ophthalmic or otic formulations.