The Food and Drug Administration (FDA) last week asked the manufacturer of the popular prescription allergy drug terfenadine -- sold under the trade name Seldane -- to warn physicians that the drug can cause potentially fatal abnormal heart rhythms in some patients.
Terfenadine's manufacturer, Marion Merrell Dow, Inc., of Kansas City, Mo., responded by sending 600,000 mailgrams to health care professionals, informing them of "rare cases of serious cardiovascular adverse events" following use of the drug, especially in patients also taking the antifungal drug ketoconazole or the antibiotic erythromycin.
Since terfenadine was approved in the United States in 1985, the FDA has recorded 64 serious cardiac events -- including cardiac arrest and various types of life-threatening arrhythmias -- among the 200 million patients who have taken the drug. Four patients who experienced the adverse events died.
A Marion Merrell Dow spokesman said that most of the events are attributable either to drug interactions with ketoconazole or erythromycin, or to preexisting liver damage that allowed terfenadine to build up to toxic levels in patients' bloodstreams. He said the company has changed terfenadine's label to advise against its use by such patients. He added that Marion Merrell Dow has deferred a decision on whether to apply for approval to sell an over-the-counter preparation of terfenadine, pending further tests of the drug's safety.
COPYRIGHT 1992 Science Service, Inc.
COPYRIGHT 2004 Gale Group
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