U.S. Food and Drug Administration

 FDA Talk Paper,   Nov 6, 2000

FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE

FDA, today, is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

FDA today issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenylpropanolamine hydrochloride.

Phenylpropanolamine 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.

Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes. Manufacturers of products containing phenylpropanolamine worked with FDA to plan a research program to clarify whether any increase in risk exists.

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 3 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.

FDA believes that although the risk of hemorrhagic stroke is very low, even with phenylpropanolamine use, the conditions for which these products are used do not appear to warrant an increased risk of this serious event from using this drug. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.

The text in this article was prepared by the FDA Office of Public Affairs.