New Cold Drugs Work, but Experts Want More Proof

While new versions of decongestants appear to work, more study is needed.

ByABC News
February 19, 2009, 7:33 AM

Dec. 14, 2007— -- WASHINGTON (AP) - Government pharmaceutical advisers on Fridaysaid new over-the-counter cold medications from Pfizer Inc. andWyeth probably work to unclog stuffy noses, but recommended furtherstudies to determine whether higher doses would be even moreeffective.

The Food and Drug Administration called the meeting to reviewphenylephrine, which was recently added to many decongestants afterdrug companies were required to take medications containingpseudophedrine off pharmacy shelves.

Pfizer's Sudafed PE, Wyeth's Dimetapp and and Procter & Gamble'sNyQuil are among the medicines that switched to the new ingredientfrom pseudophedrine. A law passed in 2006 is aimed at curbing theillegal processing of pseudophedrine into the stimulantmethamphetamine.

FDA's panel of outside experts voted 11 to 1 that there is someevidence the new formulations work, but most panelists said theexisting studies are not definitive.

"What we know from the studies completed to date is that the 10milligram dose is probably effective, but it's murky," said YaleUniversity Professor Mary Tinetti, who chaired the panel.

The group voted 9-3 in favor of studying higher doses ofphenylephrine, including a 25 mililgram dose.

Shares of Pfizer fell 54 cents to $23.10 on Friday, while thoseof Wyeth declined 27 cents to $48.56.

(Copyright 2007 by The Associated Press. All Rights Reserved.)