Phenylpropanolamine and the risk of hemorrhagic stroke.

Background: Phenylpropanolamine is commonly found in appetite suppressants and cough or cold remedies. Case reports have linked the use of products co ntaining phenylpropanolamine to hemorrhagic stroke, often after the first u se of these products. To study the association, we designed a case-control study. Methods: Men and women 18 to 49 years of age were recruited from 43 U.S. ho spitals. Eligibility criteria included the occurrence of a subarachnoid or intracerebral hemorrhage within 30 days before enrollment and the absence o f a previously diagnosed brain lesion. Random-digit dialing identified two matched control subjects per patient. Results: There were 702 patients and 1376 control subjects. For women, the adjusted odds ratio was 16.58 (95 percent confidence interval, 1.51 to 182. 21; P=0.02) for the association between the use of appetite suppressants co ntaining phenylpropanolamine and the risk of a hemorrhagic stroke and 3.13 (95 percent confidence interval, 0.86 to 11.46; P=0.08) for the association with the first use of a product containing phenylpropanolamine. All first uses of phenylpropanolamine involved cough or cold remedies. For men and wo men combined, the adjusted odds ratio was 1.49 (95 percent confidence inter val, 0.84 to 2.64; P=0.17) for the association between the use of a product containing phenylpropanolamine and the risk of a hemorrhagic stroke, 1.23 (95 percent confidence interval, 0.68 to 2.24; P=0.49) for the association with the use of cough or cold remedies that contained phenylpropanolamine, and 15.92 (95 percent confidence interval, 1.38 to 184.13; P=0.03) for the association with the use of appetite suppressants that contained phenylprop anolamine. An analysis in men showed no increased risk of a hemorrhagic str oke in association with the use of cough or cold remedies containing phenyl propanolamine. No men reported the use of appetite suppressants. Conclusions: The results suggest that phenylpropanolamine in appetite suppr essants, and possibly in cough and cold remedies, is an independent risk fa ctor for hemorrhagic stroke in women. (N Engl J Med 2000;343:1826-32.) (C) 2000, Massachusetts Medical Society.