Public Release:  Effectiveness of over-the-counter decongestant questioned in new study

Review of data indicates that phenylephrine requires further study to demonstrate efficacy and safety

Annals of Pharmacotherapy

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 efficacy--primarily nasal airway resistance--as 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 legislation now requires pseudoephedrine products to be kept "behind the counter" and sold in small quantities to prevent their use in the illegal manufacture of methamphetamine. This leaves phenylephrine as the primary ingredient in OTC decongestants available today. Original FDA approval of the drug relied on expert opinion rather than today's meta-analysis techniques to draw conclusions from the conflicting data shown in the research.

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The Annals of Pharmacotherapy is a leading peer-reviewed, international pharmacotherapy journal for physicians, pharmacists, and other healthcare practitioners. Published by Harvey Whitney Books Company, The Annals features articles directly related to the safe, effective, and economical use of medications and related devices in patient care. The journal's editorial office is headquartered at 8044 Montgomery Road, Suite 415, Cincinnati, Ohio 45236-2998, USA. The journal is available online in full text at www.theannals.com.

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