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

Standard oral dose of phenylephrine works.

FRIDAY, Dec. 14 (HealthDay News) -- A decongestant in some of the most popular over-the-counter cold medicines is effective at its current dosage, a panel of U.S. health experts ruled Friday.

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 10-milligram doses.

On Friday, members of the FDA's Nonprescription Drugs Advisory Committee voted 11-1 that existing evidence supported the effectiveness of phenylephrine at that dose. In a second vote, 9-3, it urged further study of the decongestant's safety and effectiveness at higher doses. 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, and we are committed to working with FDA to ensure that the scientific data further supports this goal."

CHPA's members include Bayer, GlaxoSmithKline, Perrigo. and most other makers of over-the-counter medicines, according to the Associated Press.

The issue had been brought to the FDA by University of Florida researchers whose review of 14 studies on phen
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