The antihistamine astemizole (Hismanal) has been voluntarily withdrawn from the market by the manufacturer. Since the approval of the drug by the U.S. Food and Drug Administration (FDA) in 1988, new adverse reaction data have required labeling changes and warnings. Adverse effects included rare serious cardiovascular events. The drug could not be used in combination with some antibiotics, protease inhibitors, certain antidepressants and even grapefruit juice. Because of the availability of new antihistamines and the risk-benefit profile of astemizole, the FDA supported the decision by the manufacturer to withdraw the product.
COPYRIGHT 1999 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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