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Concern over cold treatment studies

There is limited evidence that new types of over-the-counter cold medications actually relieve nasal congestion, US health officials have said.

The Food and Drug Administration said studies of phenylephrine, an ingredient recently added to many cold medicines, are small, poorly designed and decades-old. The agency reviewed data ahead of a meeting later this month which will discuss the use of phenylephrine in widely used nasal decongestants, such as Pfizer’s Sudafed.

Manufacturers, including Pfizer, Procter & Gamble and Wyeth, switched to phenylephrine after Congress enacted a law in 2006 that pseudoephedrine products be kept locked behind the counter and only be sold on request at pharmacies.

The law is aimed at prohibiting the illegal processing of pharmacy cold medications into the highly addictive stimulant methamphetamine.

The FDA said seven of 14 studies of phenylephrine did not show a significant improvement in nasal airflow at the currently used dosage. The FDA only requires two large, comprehensive studies to support effectiveness of a drug, however agency scientists said nearly all the phenylephrine studies were inadequate.

“The studies are small and lacking many details necessary to provide a convincing demonstration of effectiveness,” the FDA said.

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