business

Fda Warnings On Seldane's Side Effects

Bad side effects from Seldane, the hot prescription allergy drug, are causing big headaches for maker Marion Merrell Dow. On July 7, the U.S. Food & Drug Administration ordered Marion to warn doctors of possible dangerous heart arrhythmia when Seldane is taken at the same time as two other medications. Patients with liver disease also are at risk.

The safety questions are likely to scuttle the company's plan to sell the antihistamine over the counter in the U.S. And analysts expect sales growth to stall. According to some estimates, the FDA's order and the resultant bad publicity will cost Marion about $65 million in Seldane sales this year and reduce overall company profits by about $14 million, to $677 million.

The Seldane woes compound Marion's long-term problems: Cardizem, its $1 billion blood-pressure drug, will soon face generic competition, and there's little in the pipeline to take its place.

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