E-DRUG: Drug alert - Antibiotic withdrawn
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A relatively new fluoroquinolone antibiotic grepafloxacin (brand name
Raxar in the U.S.) is being voluntarily withdrawn from the U.S. market
by GlaxoWellcome the licensee of the drug from the Japanese company
Otsuka. This decision was based on the determination that grepafloxacin
has an unfavaorable risk/benefit profile due to an association of the
drug with prolongation of QT interval and related postmarketing
concerns.
Prolongation of QT interval is a rare side effect of many drugs and a
risk factor for torsades de pointes, a potentially lethal ventricular
arrhythmia (abnormal heart rythm). A number of drugs have been
associated with this potentially fatal adverse event and some of these
drugs have been removed from the market including the antihistamines
terfenadine, and astemizole, and the incontinence drug terolidine (never
marketed in the U.S.).
Syed Rizwanuddin Ahmad,MD, MPH
Medical Epidemiologist
Division of Drug Risk Evaluation I
Office of Postmarketing Drug Risk Assessment (OPDRA)
Food and Drug Administration
Center for Drug Evaluation and Research
HFD-430, Rm 15B-08
5600 Fishers Lane
Rockville, MD 20857, USA
Email: ahmads@cder.fda.gov
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