Ephedra: In the news
Last modified: Sunday, 31. May 2009 - 3:21 pm
Phenylpropanolamine (PPA), a chemical cousin of ephedra, has garnered its fair share of negative publicity. PPA, a common ingredient in over-the-counter cold remedies and diet pills, appears to be linked with an increased risk of stroke. The first reports linking PPA with intracranial hemorrhage, or stroke, involved diet pills formulated with both PPA and caffeine. The FDA banned products containing both PPA and caffeine in 1983. However, doctors continued to report some cases of stroke, which occurred after patients had taken products containing PPA. In fact, more than 30 strokes were reported in persons taking PPA since 1979. The majority of these reports involved PPA in diet pills, but a few reports involved PPA in cough and cold medicines. Many of the affected persons were young women between the ages of 17 and 45.
In 1992, both the FDA and manufacturers of products containing PPA recommended an epidemiological study of the link between PPA and stroke. Investigators at the Yale University School of Medicine designed a Hemorrhagic Stroke Project. Their goal was to find the link, if any, between PPA and stroke among men and women ages 18 to 49. They also wanted to determine the link between PPA and stroke by type of exposure (cough and cold medication or appetite suppressant). Finally, they wanted to find the link between first use of PPA and stroke and PPA in appetite suppressants and stroke in women ages 18 to 49.
The researchers at the Yale University School of Medicine studied more than 700 persons between the ages of 18 and 49 who had had a stroke. The Hemorrhagic Stroke Project was completed in 2000. When the investigators released results of the study, the report linked PPA with an increased risk of hemorrhagic stroke, or bleeding into the brain or into the tissue surrounding the brain, among women using products containing PPA for weight control or nasal decongestion. Researchers found that women taking weight-loss aids containing PPA, such as Dexatrim and Acutrim, had a 16-fold increase in their risk for hemorrhagic stroke. Many of the female study participants had the stroke after taking just one dose of the product containing PPA. The Yale physicians also concluded that men as well as women may also be at risk for hemorrhagic stroke when they take products containing PPA.
The researchers determined that people using cough and cold products containing PPA had a slightly increased risk for stroke. After the FDA’s Nonprescription Drug Advisory Committee reviewed the results of the study, the FDA asked drug manufacturers to stop selling products containing PPA and worked to remove PPA from all over-the-counter drug products. Many manufacturers of cough and cold remedies and nasal decongestants containing PPA have voluntarily reformulated their products and eliminated PPA as an ingredient. Nevertheless, the FDA urged all consumers to carefully read the labels of cold remedies to insure that they do not contain PPA. As of 2002, some manufacturers of cold products had started to advertise their products as PPA-free.