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A good drug turned bad?

Allergy sufferers rejoiced when Seldane appeared on the market -- the first antihistamine to relieve the sneezing, watery eyes, and runny noses of pollen allergy without making the user sleepy. By 1995, the manufacturer, Hoechst Marion Roussel, was selling $630 million of Seldane worldwide.

In 1992, however, several deaths among liver patients and patients taking Seldane at the same time they were using ketoconazole or erythromycin caused the FDA and the drug company to warn doctors, pharmacists, and patients of the potential danger of taking Seldane at the same time as these other two drugs. With the arrival of a new drug, fexofenadine, a derivative of terfenadine (the generic name for Seldane), the FDA is now proposing to remove its approval of Seldane and take it off the market.

Fexofenadine, also manufactured by Hoechst, received FDA approval last July and is marketed under the brand name Allegra. Time will tell whether the FDA will take Seldane off the market, however. Both Hoechst and the manufacturer of generic terfenadine (which the FDA approved only two months ago) oppose the FDA proposal. Hoechst has only a 17 percent share of the American antihistamine market, compared to 64 percent for Schering-Plough's brand of antihistamine, known as Claritin.
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Title Annotation:Seldane
Author:Brown, Edwin W.
Publication:Medical Update
Date:Mar 1, 1997
Words:203
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