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OTC drug linked to brain stroke, taken off market

The Food & Drug Administration (FDA) has called for the withdrawal of all drugs containing phenylpropanolamine, also known as PPA, from the marketplace.

The recall was based on evidence that the drug -- used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products -- is linked to an increased risk of hemorrhagic stroke, or bleeding into the brain.

The ingredient is found in many popular products -- ranging from Dexatrim to Triaminic -- and it is estimated that several millions Americans take PPA every day. The FDA estimates that 200-500 people under age 50 may suffer strokes each year because of the drugs. This age group is normally considered a low-risk group for strokes.

Scientists at Yale University School of Medicine conducted the study in which the researchers found an association between phenylpropanolamine use and stroke in women. The increased risk of hemorrhagic stroke was detected among women using the drug for weight control, and for nasal decongestion, in the three days after starting use of the medication. Men may also be at risk.

The Nonprescription Drugs Advisory Committee met on October 19 to discuss safety issues related to phenylpropanolamine use. The committee reviewed Yale's Hemorrhagic Stroke Project results and concluded that phenylpropanolamine cannot be considered to be safe for continued use.

SOURCE: FDA Talk Paper, November 6, 2000.

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