FDA Issues Warning on Drugs with PPA

Cold and diet drug ingredient linked to strokes

WASHINGTON--The Food and Drug Administration asked manufacturers to voluntarily stop selling drugs containing phenylpropanolamine (PPA) on Monday after the agency reported that there was a link between hemorrhagic strokes among young women and use of the drug.

According to Associated Press reports, the FDA plans to ban PPA, which is found in over-the-counter drugs such as Tavist-D, Dexatrim and other cold remedies. Manufacturers are being asked to replace the ingredient with safer alternatives.

Drug stores across the country, including Rite-Aid, Walgreen Co and CVS Pharmacy all plan to post warning signs and removing products from the shelves. While customers can resort to drugs containing safer alternative ingredients, such as pseudoephedrine for cold and allergy medications, those using diet pills are advised to check with their physicians, as over-the-counter alternatives do not exist for diet medications.

SmithKline Beecham Consumer Healthcare has advised against using its Contac 12-Hour Cold Capsules, but says five other versions of Contac contain the safe alternative psuedoephedrine.

Hemorrhagic strokes--or bleeding in the brain--is usually rare among people under 50 years of age. A five-year study by Yale University compared PPA use among stroke survivors and healthy people and concluded that PPA increases stroke risk for young women within three days of taking a dose of PPA. According to this study, using PPA increased stroke risk 12 to 15-fold. Risk was highest with higher doses (more than 75 milligrams daily).

The study didn't find men at risk, reports the AP. The FDA cautioned that enough men weren't studied to be sure that there is no threat to men.