Stroke risk for women present in certain over-the-counter meds

A dangerous substance—phenyl propanolamine (PPA)—is found in several nonprescription cold medicines and all nonprescription appetite suppressants, according to an account released by the Food and Drug Administration (FDA).

The agency has taken steps to discourage nonprescription drug manufacturers from using the substance, following the release of an industry-sponsored study, which found an increased risk of stroke for women who use products containing PPA. Specifically, the study found that women between the ages of 18 and 49 are at an increased risk for hemorrhagic stroke—a stroke condition that results in bleeding in the brain. The condition is relatively rare in persons under the age of 50. However, women who take PPA-containing appetite suppressants are up to 15 times more likely to suffer hemorrhagic stroke, regardless of age. Additionally, women are also up to three times more likely to suffer such strokes within three days of taking any drug containing PPA for the first time. The study included too few male subjects who reported using PPA and suffering strokes to draw any conclusions about the risk to men.

After the release of the study, the FDA asked all manufacturers to voluntarily discontinue use of the substance. The FDA estimates that between 200 and 500 strokes per year are attributable to PPA ingestion. The agency has announced plans to initiate rule making to permanently ban the use of PPA in nonprescription drugs. The FDA has also expressed concerns about the use of PPA in prescription drugs but has not specified a course of action in this area.

The group that sponsored the study—an industry trade group—has responded to the results by express skepticism about the validity of the study results. The group believes that the results are unreliable, stating that the sample size used was too small to establish a causal link between the drug and strokes. Other industry critics have claims that the study subjects who had suffered stroke demonstrated a greater number of risk factors than the general population, including a history of smoking, alcohol use, and drug use. Industry representatives maintain that the drug is safe when used as directed.

The industry is recommending the adoption of uniform labeling requirements designed to alert customers to the risks associated with using multiple PPA-containing products simultaneously or in higher doses than recommended.

PPA was found in some products marketed under the following brad names: AcuTrim, Alka-Seltzer, BC Allergy, Sinus, Comtrex, Contac, Coricidin, Dexatrim, Dimetapp, Nadlecon, Permathene, Robitussin, Tavist-D, and Triaminic. PPA is also used in a number of generic substances. Accordingly, the FDA recommends that all consumers read labels on nonprescription drugs in order to avoid PPA-containing medications. Walgreens, CVS, and Rite-Aid have agreed to discontinue the sales of products containing PPA and SmithKline Beecham and Bristol-Myers Squibb have said they will no longer manufacture products containing PPA.

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