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FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
Posted 2 Mar 2011 by Drugs.com
WEDNESDAY, March 2 – The U.S. Food and Drug Administration said Wednesday that it plans to remove about 500 unapproved prescription cough, cold, and allergy medicines from pharmacy shelves. These drugs have not been evaluated by the FDA for safety and effectiveness, and they may be riskier to take than approved over-the-counter (OTC) drugs that treat these same conditions, agency officials explained. "This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don't know what's in them, whether they work properly or how they are made," Deborah M. Autor, director of the agency's Office of Compliance at the Center for Drug Evaluation and Research, said during a morning news conference. Of particular concern are drugs that have time-release formulations, Autor said. "We know from experience that these type of products are complicated to ... Read more
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