CINCINNATI, January 31, 2007 -- The only over-the-counter (OTC) oral decongestant currently available without restriction may be less effective than previously thought, according to a new study. The research, published this week in the online edition of The Annals of Pharmacotherapy at www.theannals.com, evaluates the effectiveness of phenylephrine, the active ingredient in products such as Actifed, Sudafed PE, and Tylenol Sinus. This meta-analysis of 15 previous studies concludes that the standard 10 mg dose of the drug appears to be no more effective than placebo and suggests that the FDA should require additional studies to prove the drug's safety and efficacy. Dr. Leslie Hendeles, one of the study's authors, appeared on today's broadcast of Good Morning America to discuss the efficacy of OTC decongestants.

The reviewed studies contained objective assessments of phenylephrine's efficacyprimarily nasal airway resistanceas well as subjective measurements of patient-reported congestion relief. Changes in both measures varied widely among the studies and when statistically combined using meta-analysis techniques, no consistent benefit from the drug could be detected. Reasons for the inconsistencies have not been determined.

Phenylephrine is a drug known to have a low oral bioavailability, meaning that only a small fraction of the dose actually ends up in the bloodstream. As a result, higher-than-expected doses may be necessary to achieve measurable effects. However, it remains to be seen whether these higher doses could increase the risk of adverse effects such as increases in blood pressure or heart rate in some patients.

Phenylephrine, pseudoephedrine, and phenylpropanolamine were declared safe and effective for nonprescription use by the US Food and Drug Administration in 1976. Since then, phenylpropanolamine was removed from the market after being associated with hemorrhagic strokes, and legi
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Contact: Stan Lloyd PharmD
nwsjloyd@theannals.com
Annals of Pharmacotherapy
31-Jan-2007