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FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
Date:3/2/2011

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, March 2 (HealthDay News) -- 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 manufacture," she explained, and the agency's concern is that these products may not release medication consistently or safely.

Another big concern involves unapproved cough, cold and allergy medications labeled for use by children under the age of 2. In 2008, the FDA released a warning against the use of OTC cough and cold products for infants and children under age 2 because of serious, potentially life-threatening side effects.

Officials are also worried about serious side effects with some of these unapproved drugs such as sedation and drowsiness, and name confusion that can lead to prescribing errors, she said.

Despite the requirement that prescription drugs be evaluated by the FDA before they can be sold, many of these medications were never approved, Autor explained.

"Some of these products have been marketed for many years, and have remained on the market illegally," she said. "Some entered the market illegally simply because they [manufacturers]
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