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Over-the-Counter Drugs May Cause Strokes

Cough, Cold, Allergy Decongestants Containing Ephedrine, Pseudoephedrine May Increase Risk

By Salynn Boyles
WebMD Medical News

Reviewed By Brunilda Nazario, MD
on Friday, July 11, 2003

July 11, 2003 -- The active ingredients in some of the most commonly used over-the-counter cough, cold, and allergy remedies are once again being linked to an increase in stroke risk, even in people who take the medications as directed.

Researchers in Mexico evaluated 2,500 patients who had strokes and concluded that in 22 cases their strokes were caused by taking over-the-counter (OTC) drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine (PPA).

The chemically similar compounds have been under suspicion for years, and in 2000 the U.S. Food and Drug Administration ordered the removal of products containing PPA from the market. The FDA action came soon after a Yale University study linked its use in appetite suppressants and cough and cold remedies to strokes in seemingly healthy young and middle-aged women.

At the time, FDA officials estimated that PPA was responsible for between 200 and 400 stokes per year.

In response to the FDA request, over-the-counter cough, cold, and allergy products sold in the United States no longer contain PPA, but the agency still recommends that consumers read the labels of cough, cold, allergy, and diet drugs to make sure.

Many over-the-counter remedies do still contain ephedrine and pseudoephedrine, however. In 1995, the FDA published a proposal to remove epedrine products from the market, but the proposal has not been finalized. In a statement to WebMD issued Friday, FDA officials wrote that they are currently reviewing the status of products containing ephedrine and "are projecting some further rulemaking for these products."

In the July issue of the American Heart Association publication Stroke, neurologist Carlos Cantu, MD, and colleagues detail the cases of 22 patients whose strokes they believe were linked to the use of drugs containing PPA and ephedrine. Just under half of the patients were men, and more than half (12 of 22) were younger than 40 at the time of their strokes.

Sixteen of the patients took over-the-counter products containing PPA, and the rest took drugs containing ephedrine or pseudoephedrine. Roughly a third of patients took the drugs less than an hour before their strokes occurred.

Though most patients took more than the recommended amount of medication, a few strokes occurred among people taking accurate doses for brief periods, and a few strokes occurred in patients who had taken these drugs over a longer period of time. Most of the patients did not have the typical risk factors for stroke, although two of the patients had reported a history of high blood pressure.

"The Yale study implicated diet drugs, which are often used for long periods," neurologist John C. Brust, MD, tells WebMD. "There has been considerable suspicion that cold remedies are also of concern, and this research supports that view."

In an editorial published along with the study, Brust says the findings show that the FDA's decision to ask manufacturers to take PPA out of their products was the right one. Critics have charged that it was based on flimsy scientific evidence.

Brust tells WebMD products containing ephedrine or the unregulated supplement ephedra, also sold as ma huang, may be every bit as dangerous as PPA. Ephedra-containing supplements have been implicated in hundreds of cases of heart attacks and strokes. In a February interview with WebMD, University of Georgia exercise science Professor Patrick O'Connor, PhD, said as many as 80 deaths could be linked to use of the supplement, including 20 deaths among young people serving in the military