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Phenylpropanolamine (PPA) Information Page

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA.  In addition, FDA has issued a public health advisory concerning phenylpropanolamine hydrochloride. This drug is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

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.

FDA’s Nonprescription Drugs Advisory Committee recently discussed this study and other information on phenylpropanolamine. The Committee  determined that there is an association between PPA and hemorrhagic stroke and recommended that PPA not be considered safe for over-the-counter use.

For more information on this public health advisory, please see the items below.

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FDA/Center for Drug Evaluation and Research
Last Updated: November 15, 2000
Originator: OTCOM/DLIS