Studies question effectiveness of over-counter cold remedies

WASHINGTON (AP) — There is limited evidence that new formulations of over-the-counter cold medications actually relieve nasal congestion, federal health officials said Monday.

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 on phenylephrine in widely used nasal decongestants like Johnson & Johnson’s Sudafed.

Manufacturers, including Johnson & Johnson, Procter & Gamble Co. and Wyeth, switched to phenylephrine after Congress enacted a law in 2006 that pseudoephedrine products be kept locked behind the counter and sold on request at pharmacies. The law is aimed at prohibiting the illegal processing of drug-store cold medications into the highly addictive stimulant methamphetamine.

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