Phenylpropanolamine (PPA) Lawyers

Citing a possible risk of stroke, the U.S. Food and Drug Administration is advising people to stop taking over-the-counter cold medicines or appetite suppressants that contain phenylpropanolamine, or PPA. The regulatory agency also is asking drug manufacturers to discontinue use of the ingredient in products.

"FDA intends to initiate rulemaking to classify phenylpropanolamine as... not generally safe and effective for over-the-counter use," agency director Dr. Janet Woodstock wrote in a letter to manufacturers last week. "As an interim measure to protect the public health, you should voluntarily discontinue marketing any drug products containing phenylpropanolamine."

PPA is an ingredient used in dozens of over-the-counter cough-and-cold remedies made by Alka-Seltzer, BC, Comtrex, Contac, Dimetapp, Robitussin, Tavist-D and Triaminic, among others. It also is a key ingredient in appetite suppressants marketed as Acutrim and Dexatrim. While cough-and-cold medicines are available without PPA, it is the only nonprescription appetite suppressant on the market.

Dieters should consult their physician concerning options, said FDA nonprescription drugs chief Dr. Charles Ganley.

Two weeks ago, an FDA advisory committee accepted the findings in a Yale University study that suggested PPA could be linked to between 200 and 500 hemorrhagic strokes a year. Usually rare, hemorrhagic stroke is caused by bleeding in the brain.

"Case reports have linked the use of products containing phenylpropanolamine to hemorrhagic stroke, often after the first use of these products," Dr. Walter Kernan, an associate professor of medicine at Yale University, wrote in the study being released today in the New England Journal of Medicine. Publication had been scheduled for December 21, but was moved up because of the FDA action.

"Our results suggest that a woman who uses PPA in an appetite suppressant is 16 times more likely to suffer a hemorrhagic stroke than a woman who does not use PPA," added Kernan, a lead author of the Yale study. The study found no associated increase in risk for men, he said.