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FDA Warns Americans on Over-the-Counter Medications

© Gretchen Malik

A number of major drug store chains are pulling dozens of over-the-counter cold remedies and diet pills from their shelves after the government warned that an ingredient could cause hemorrhagic strokes, especially in young women. The Food and Drug Administration issued an unusually strong warning informing Americans to immediately quit using drugs containing phenylpropanolamine, or PPA, which is in dozens of other over-the-counter medicines. Manufacturers are being asked to voluntarily stop selling PPA-containing drugs immediately and to replace the ingredient with a safer alternative. Thirty-eight hundred drug stores in 30 states and the District of Columbia will soon begin posting warning signs and removing PPA products with PPA.

Buyers, especially women, should be alert for PPA in the ingredient list of nonprescription cold relievers - both brand names and generic or store brands - and instead choose decongestant pills with the safe alternative pseudoephedrine or use nasal sprays. Since over-the-counter alternatives do not exist for diet pills, dieters will have to consult doctors about prescription-only alternatives.

About 6 billion doses of PPA are sold in this country each year, mostly without prescriptions. There are a few PPA-containing prescription decongestants. While the risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user, these are often deadly strokes, and survivors can be left disabled.

With millions of Americans swallowing PPA daily, the FDA estimated it could be to blame for 200 to 500 strokes yearly just in people under age 50. Nobody knows why, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses - more than 75 milligrams daily - that dieters typically used.

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