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

Current evidence says 10-milligram dose works, but advisers urge study of higher doses

FRIDAY, Dec. 14 (HealthDay News) -- A decongestant in many of the most popular over-the-counter cold medicines appears effective at its current dosage, U.S. health experts ruled Friday. But they also urged that more studies be done.

The panel of advisers to the U.S. Food and Drug Administration had heard day-long testimony on whether OTC cold medicines containing the decongestant phenylephrine really provide nasal congestion relief.

The medicines, which include Sudafed PE, Robitussin Night Relief Syrup, Tylenol Sinus and DayQuil capsules, all contain phenylephrine in a 10-milligram dose.

On Friday, members of the FDA's Nonprescription Drugs Advisory Committee voted 11-1 that existing evidence seems to support the effectiveness of phenylephrine at that dose.

In a second vote, 9-3, the panel urged further study of phenylephrine's safety and effectiveness at higher doses, including 25 milligrams, the Associated Press reported.

"What we know from the studies completed to date is that the 10- milligram dose is probably effective, but it's murky," said Yale University Professor Mary Tinetti, who chaired the panel.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Industry experts applauded the panel's vote.

Linda A. Suydam, president of the Consumer Healthcare Products Association, said in a prepared statement that the vote "reaffirms the results of numerous scientific studies and decades of consumer experience. CHPA and the leading makers of OTC cough, cold, and allergy medicines containing phenylephrine are committed to adding to the existing body of evidence currently supporting the safety and efficacy of phenylephrine."

She added, "Our goal is to continue to provide consumers with safe and effective therapies, an
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