FDA panel: popular decongestant ingredient unsafe

Stroke risk cited

WASHINGTON (CNN) -- An advisory committee for the Food and Drug Administration agreed Thursday that an ingredient commonly used in over-the-counter diet aids and decongestants is unsafe, and it plans to recommend further review by the FDA.

The FDA Non-Prescription Drugs Advisory Committee met Thursday to discuss a new five-year study by Yale University researchers that found phenyl-propanolamine (PPA), an active ingredient in non-prescription drugs, can increase the risk of stroke in some users.

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PPA helps constrict blood vessels, thus relieving nasal congestion, and has been shown to aid in weight loss. The compound is in hundreds of over-the-counter cold, cough and allergy medicines and appetite suppressants.

The Yale study involved 702 patients between the ages of 18 and 49 who had suffered hemorrhagic strokes, or bleeding in the brain. The stroke patients were matched on the basis of age, gender, race and geographic location with control subjects who had not had a stroke.

The study found evidence that linked PPA to the stroke patients, who were 50 percent more likely than the control subjects to have used PPA within three days of the onset of their stroke symptoms.

"I don't think there's any question in my mind that PPA appears to increase the risk of brain hemorrhage," said Dr. Ralph Horwitz, lead author of the study and chairman of internal medicine at Yale.

But the Consumer Healthcare Products Association (CHPA), a trade association that represents manufacturers of over-the-counter drugs and dietary supplements and the study's funder, said the study was "inconclusive" and did not support a challenge to the safety of PPA in over-the-counter medicines.

"This evidence from clinical trial and adverse-event tracking, when taken together, overwhelmingly supports the safety and effectiveness of PPA when used as directed on product labeling." said R. William Soller, Ph.D. and Director of Science & Technology at CHPA. "We strongly disagree with any broad-sweeping statements and conclusions about the results of the Yale study that explicitly state or imply it represents strong epidemiologic evidence applicable to the general population."

Reports linking PPA to hemorrhagic stroke began to surface more than 20 years ago.

PPA is listed as an active ingredient in over-the-counter diet products from Acutrim and Dexatrim, and non-prescription cold medicines made by Alka-Seltzer, BC, Comtrex, Contac, Dimetapp, Robitussin, Tavist-D, and Triaminic, among others.

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American Stroke Association
National Stroke Association
Internet Stroke Center at Washington University
National Institute of Neurologial Disorders and Stroke

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