FDA Mulls Effectiveness of OTC Col...( Standard oral dose of phenylephrine d...),Health

Standard oral dose of phenylephrine does nothing to clear the nose, studies suggest

FRIDAY, Dec. 14 (HealthDay News) -- Beginning Friday, a panel of U.S. Food and Drug Administration (FDA) experts is considering the following claim from researchers: that certain over-the-counter cold medicines do nothing to clear nasal congestion.

The products in question are oral OTC decongestants containing 10 milligrams per dose of phenylephrine. Studies have suggested that pill and syrup versions of these medicines -- which include Sudafed, Robitussin Night Relief Syrup, Tylenol Sinus and DayQuil capsules -- offer users no real relief.

"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," contends Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida.

He led an extensive data review, published in the July 2006 issue of the Journal of Allergy and Clinical Immunology, that looked at 14 studies focused on the effectiveness of phenylephrine.

Hendeles' conclusion: The products did not relieve nasal congestion.

Based on those findings, Hendeles petitioned the FDA to further investigate the matter, and to boost the maximum allowable dose of phenylephrine in oral decongestants to 25 milligrams, which he believes may be more effective but still safe.

So, on Friday, a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and the Endocrinology and Metabolic Drugs Advisory Committee is listening to testimony on the effectiveness of the current formulation of phenylephrine-containing pills and syrups at relieving nasal congestion.

Hendeles is pushing the FDA to force companies to do studies that compare different doses of phenylephrine to find the most effective one while that is still safe. "There needs to be
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