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FDA Issues Warning About Ingredient in Cold Remedies, Diet Pills

WebMD Health News

Reviewed by Charlotte E. Grayson Mathis, MD

Nov. 6, 2000 (Washington) -- In a decisive move, the FDA issued a public health advisory on Monday warning Americans to seek alternatives to a number of over-the-counter cough and cold medicines and diet pills containing phenylpropanolamine, or PPA, because they may lead to strokes.

According to a written release from the FDA, the move is a step in the direction of removing PPA from all drug products. Until a ban can be put in place, though, the FDA also has requested that all drug companies discontinue marketing products containing PPA.

The announcement coincides with the early release of two studies from the prominent medical journal The New England Journal of Medicine demonstrating that PPA may cause strokes in young, healthy people and raising concerns that the popular dietary supplement, ephedra or ma huang, may have similar life-threatening effects.

In October, PPA made headlines when a committee of experts suggested that the drug was not safe for over-the-counter use. The recommendation was based on findings from a study from Yale University that showed PPA could possibly cause a stroke, even in healthy individuals aged 18 to 49. That study is the one being published early in The New England Journal of Medicine. The recently completed five-year study was scheduled to be published in the Dec. 21 issue, but was released early because of its "potential clinical and public health implications."

The researchers found that among women between the ages of 18 and 49, the use of a product containing PPA as an appetite suppressant was associated with an increased risk of stroke. They caution that the effect also may occur in men, people who are older than 49 or younger than 18, and when PPA is taken in the form of a cough or cold remedy. In fact, the FDA believes that PPA is responsible for about 200 to 500 strokes per year.

PPA has been a popular active ingredient in several over-the-counter cold remedies for about 50 years, and it currently is found in many commonly used drugs such as Dimetapp, Robitussin and Comtrex, and the appetite suppressants Dexatrim and Acutrim.

On the heels of the recent concerns over the safety of PPA, several manufacturers of drugs containing PPA announced that they are in the process of replacing it with other ingredients because, in large part, of fears that an eventual FDA ban might lead to lawsuits.

But the swift and decisive stand by the FDA to limit access to PPA highlights how little control it has over regulating the use of another widely available and potentially dangerous compound: ephedra. Ephedra is a common ingredient in dietary supplements that claim to help people lose weight and increase energy levels.

Another study released early by the The New England Journal of Medicine shows that the use of ephedra-containing compounds was linked to a number of serious events, including high blood pressure, rapid heart rate, stroke, seizure, and even death.