Phenylpropanolamine - PPA : Strokes

In 2000, the FDA began taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, the FDA has issued a public health advisory concerning phenylpropanolamine (PPA). PPA is an ingredient used in many over-the-counter and prescription cough and cold medications as a decongestant and in OTC weight loss products.
In response to the request made by the FDA in November 2000, many companies have voluntarily reformulated and are continuing to reformulate their products to exclude PPA while FDA proceeds with the regulatory process necessary to remove PPA from the market.

PPA Side Effects

Scientists at Yale University School of Medicine recently issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project." This study reports that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA.

In addition to strokes, other serious adverse reactions attributed to PPA include acute psychosis, convulsions, acute renal failure, heart damage, and hypertension.

PPA and Strokes

FDA's Nonprescription Drugs Advisory Committee discussed this Yale study in November, 2000 along with additional information on phenylpropanolamine (PPA). The Advisory Committee determined that there is an association between PPA and hemorrhagic stroke. It recommended that PPA be considered not safe for over-the-counter use.