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FDA Panel Finds OTC Cold Remedies Effective
Date:12/14/2007

ylephrine suggested that pill and syrup versions of these medicines offered users no real relief. The researchers had petitioned the FDA to investigate the matter and also examine the possibility of requiring higher doses that would work.

Drug companies have recently turned to phenylephrine as a replacement for another decongestant, pseudoephedrine, to comply with a 2006 U.S. law requiring that products containing pseudoephedrine be sold from behind the counter. The law was designed to prevent these medications from being bought in bulk and turned into methamphetamine.

On the academics' side, according to the AP, was drug maker Schering-Plough, which had decided not to reformulate its Claritin line of decongestants, which contain pseudoephedrine.

"If you have a stuffy nose, and you take an over-the-counter product containing phenylephrine, you will still not be able to breathe through your nose after you take it. That's the bottom line," Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida, contended before the advisers met.

Hendeles had led the review, which was published in the July 2006 issue of the Journal of Allergy and Clinical Immunology, and he had petitioned the FDA to boost the maximum allowable dose of phenylephrine in oral decongestants to 25 milligrams, which he believes may be more effective.

"There needs to be a dose-response study where you look a 10-, 25- and 50-milligram doses and determine what dose would give you a relief of your stuffy nose without side effects," he said.

But one expert worried that boosting doses of phenylephrine might come at a price.

"No medicine ever has been shown beyond the shadow of a doubt to be effective for the common cold," noted Dr. Bruce Barrett, an associate professor of family medicine at the University of Wisconsin in Madison. "The main problem with decongestants is that they stimulate the heart a
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