The Food and Drug Administration's scientific advisory committee determined that phenylpropanolamine (PPA) cannot be classified as safe, a classification critical to drugs' ability to be sold without a prescription - based upon their interpretation of a study called Phenylpropanolamine and Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project.

According to published reports, the FDA already was reviewing the safety of PPA, and the advisory committee's recommendation strengthens the possibility of an action by the FDA to limit the drug's use. While the FDA is not bound by the committee's recommendation, it usually follows them.

The American Stroke Association supports the recommendations of the FDA regarding PPA. The FDA advisors included a group of independent scientists with full knowledge of the issue; therefore, the American Stroke Association supports the FDA advisory committee's interpretation of the study and its recommendations.

"This information is helpful because it educates the public about the importance of ingredients in over-the-counter products and the issue of drug-related strokes, particularly in the young as well as the elderly taking other medications," said Edgar J. Kenton, III, M.D., the Chair of the American Stroke Association Advisory Committee. "In addition, the study highlights the need for further investigation on the effect of PPA in larger populations and ethnic groups."

"The American Stroke Association recommends that Americans speak with their healthcare professional to discuss alternatives to over-the-counter products containing PPA, such as cough medicine, diet pills and decongestants, particularly if they have other risk factors for stroke," said Raymond L. Woosley, M.D., Ph.D., an American Heart Association volunteer, and Chairman of the Department of Pharmacology at Georgetown University Medical Center.

He also cautioned that the public should not assume that other weight loss products that can increase blood pressure, such as herbal dietary supplements containing cardiac stimulants, are safe alternatives to PPA. These products have not been adequately tested for safety, have been associated with reports of stroke and other cardiovascular events, and are being reviewed by the FDA at this time.

The American Stroke Association, whose mission is to reduce disability and death from stroke, believes that it must be proactive in educating the public about new medical findings and potential dangers that may affect their health and the incidence of stroke. The American Stroke Association, a division of the American Heart Association, was created in November 1998 as part of a strategic decision to emphasize the importance of stroke. In its 1998-1999 fiscal year, the association spent $54 million on stroke-related research and programs - more than any other nonprofit organization.