Sleep drug product labels to change
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WASHINGTON, March 14 The U.S. Food and Drug Administration has ordered manufacturers of drugs used to help people sleep to strengthen warnings about potential risks.The FDA said all manufacturers of sedative-hypnotic drug products -- a class of drugs used to induce or maintain sleep -- must strengthen their product labeling to include stronger language about such risks as severe allergic reactions and complex sleep-related behaviors. Those behaviors include sleep-driving, which is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.There are a number of prescription sleep aids available that are well-tolerated and effective for many people, said Dr. Steven Galson, director of the FDA ' s Center for Drug Evaluation and Research. However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform healthcare providers and consumers about risks.The FDA also ordered the pharmaceutical companies to notify healthcare providers about the new warnings.The medications of concern to the FDA are: Ambien/Ambien CR, Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.Copyright 2007 by UPI
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