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FDA Warns of Risk of Stroke from Cold and Diet Drugs

On November 6, 2000, the Food and Drug Administration warned that an ingredient in cold and diet drugs could cause a 12- to 15-fold increased stroke risk, especially in young women. 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.

The FDA issued an unusually strong warning, telling Americans to immediately quit using drugs containing phenylpropanolamine, or PPA, which is found Dexatrim, Tavist-D and dozens of other over-the-counter medicines. The agency, which intends to ban the ingredient, asked manufacturers voluntarily to stop selling PPA-containing drugs immediately and to replace the ingredient with a safer alternative.

Whitehall-Robins Healthcare quit shipping PPA-containing Dimetapp on Monday. SmithKline Beecham Consumer Healthcare said people should not use its PPA-containing Contac 12-hour Cold Capsules.

Risk is small, but effects can be deadly

These top-selling brands contain PPA: Novartis Corp. Triaminic and Tavist-D; Bayer Corp., Alka-Seltzer Plus cold medicines; and Chattem Inc. Dexatrim diet pills.

About 6 billion doses of PPA are sold in this country each year, mostly without prescriptions. There are a few PPA-containing prescription decongestants, and the FDA asked their makers also to stop selling them while it moves to ban prescription use as well.

Although the risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user, more than 6 billion doses of these drugs sold in this country each year. With millions of Americans swallowing PPA daily, the FDA estimated it could be to blame for 200 to 500 often deadly strokes yearly just in people under age 50. Survivors are often left disabled for life.

Hemorrhagic strokes typically occur in the elderly, and are extremely rare under age 50. In the 1980s, however, medical journals cited several dozen young women who suddenly had strokes days after taking their first PPA-containing diet pill.

A five-year Yale University study comparing PPA use among stroke survivors with healthy people concluded that PPA increases stroke risk for young women within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. In some cases, using PPA increased stroke risk 12- to 15-fold.

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.

The study didn't find men at risk, but the FDA cautioned that enough men weren't studied to be sure they're OK.

Dr. Hansen’s Rx: Don’t take drugs, take Phytobiotic for Colds and Succeed to lose weight.

For more information about Phytobiotic, go here: Phytobiotic

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