U.S. Food and Drug Administration • Center for Drug Evaluation and Research

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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 Yale study along with additional information on phenylpropanolamine. 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.

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

o                                                        FDA Talk Paper on Phenylpropanolamine (PPA).  11/6/2000.

o                                                        Public Health Advisory.  Subject:  Safety of Phenylpropanolamine (PPA). 11/6/2000.

o                                                        Questions and Answers about Phenylpropanolamine (PPA).  11/6/2000.

o                                                        Science Background Statement on Safety of Phenylpropanolamine (PPA).  11/6/2000. 

o                                                        FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000. Posted 11/6/2000.

o                                                        Nonprescription Drugs Advisory Committee Meeting: Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products, (10/19/00).  This link leads to the meeting agenda, roster, questions, presentation slides, and briefing information, including the Yale Hemorrhagic Stroke Project:  Final Study Report.

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Last Updated: October 17, 2007
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