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FDA panel rejects behind-counter status for cough meds

NEWS IN BRIEF — Posted Sept. 27, 2010

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Cough suppressants containing the sometimes-abused ingredient dextromethorphan probably will remain available in drugstore aisles.

The Food and Drug Administration's Drug Safety and Risk Management Advisory Committee voted 15-9 on Sept. 14 to reject restrictions on the medications that, at eight to 20 times the maximum over-the-counter dose, can cause irregular heartbeat, brain damage, seizures and loss of consciousness. The FDA usually follows advisory panel recommendations.

Emergency department visits associated with recreational use of cough medicines nearly doubled from 4,634 in 2004 to almost 8,000 in 2008, according to the FDA. The Consumer Healthcare Products Assn., which represents OTC manufacturers and distributors, applauded the vote, saying the vast majority of consumers would be unduly inconvenienced by putting cough suppressants behind the counter. In 2007, the trade group launched a website, stopmedicineabuse.com, devoted to helping parents talk with teens about the dangers of cough drug misuse.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2010/09/27/prbf0927.htm.

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