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Phenylpropanolamine and the Risk for Hemorrhagic Stroke in Women

Over the past 2 decades, there have been anecdotal reports of hemorrhagic stroke occurring after the ingestion of phenylpropanolamine, a sympathomimetic amine commonly found in over-the-counter cold remedies and appetite suppressants. These authors, in collaboration with the FDA and with manufacturer support and cooperation, undertook a case-control epidemiologic study to evaluate this association.

Between December 1994 and July 1999, men and women aged 18 to 49 were recruited at 43 U.S. hospitals. Eligibility criteria were (1) a diagnosis of subarachnoid or intracerebral hemorrhage within 30 days before enrollment and (2) no history of a brain lesion that would predispose them to the occurrence of hemorrhage. A total of 702 cases (55 percent women) and 1376 community-based controls (matched for sex, race, and age) were identified. For women, the adjusted odds ratio (OR) for hemorrhagic stroke with use of appetite suppressants containing phenylpropanolamine was 16.58 (95 percent CI, 1.51-182.21); the OR for this outcome with first use of a phenylpropanolamine-containing product was 3.13 (95 percent CI, 0.86 to 11.46). All identified first uses of phenylpropanolamine involved cold or cough preparations. In men, no increased risk for hemorrhagic stroke was observed with use of cough or cold remedies containing phenylpropanolamine. No men reported use of appetite suppressants.

Comment: This landmark study provides strong evidence that use of phenylpropanolamine elevates the risk for hemorrhagic stroke in women. Based on the OR of 16.58, the authors estimated that 1 woman might experience a stroke for every 107,000 who use phenylpropanolamine appetite suppressants (within 3 days before the -- i.e., the day and time that marked the onset of symptoms). In early November, the FDA announced that phenylpropanolamine will be withdrawn from the U.S. market. A disturbing, albeit not surprising, finding in this study is the frequency with which women use over-the-counter appetite suppressants compared with men.

— AM Kaunitz

Published in Journal Watch Women's Health December 4, 2000

Citation(s):

Kernan WN et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med 2000 Dec 21 343 1826 -1832. http://www.nejm.org/content/kernan/1.asp

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