http://www.nejm.org/doi/full/10.1056/NEJM200012213432501
Phenylpropanolamine is a synthetic sympathomimetic amine commonly found in appetite suppressants and cough and cold remedies. Each month, millions of Americans use products containing phenylpropanolamine. Since 1979, more than 30 case reports have been published that describe the occurrence of intracranial hemorrhage after the ingestion of phenylpropanolamine.1-9 Affected patients were most commonly adolescent girls or young women between the ages of 17 and 45 years who were using phenylpropanolamine-containing appetite suppressants, often for the first time.7-13 In addition to the published reports, between 1969 and 1991, the Food and Drug Administration (FDA) received 22 spontaneous reports of hemorrhagic stroke associated with phenylpropanolamine in appetite suppressants (in 16 cases) or cough and cold remedies (in 6 cases) (Jolson HM: personal communication).
In response to the concern aroused by these case reports, in 1992 we collaborated with the FDA and manufacturers of phenylpropanolamine to design the Hemorrhagic Stroke Project, a case–control study of men and women who were 18 to 49 years of age. The study had three prespecified aims: to estimate, among women, the association between hemorrhagic stroke and the use of appetite suppressants containing phenylpropanolamine and any first use of products containing phenylpropanolamine; to estimate, among men and women, the association between any use of phenylpropanolamine in either an appetitie suppressant or a cough or cold remedy and hemorrhagic stroke; and to estimate, among men and women, the association between hemorrhagic stroke and the type of exposure to phenylpropanolamine.
Methods
Men and women 18 to 49 years of age were recruited from 43 U.S. hospitals. Eligibility criteria included the occurrence of a subarachnoid or intracerebral hemorrhage within 30 days before enrollment and the absence of 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 containing 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 women combined, the adjusted odds ratio was 1.49 (95 percent confidence interval, 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 phenylpropanolamine. An analysis in men showed no increased risk of a hemorrhagic stroke in association with the use of cough or cold remedies containing phenylpropanolamine. No men reported the use of appetite suppressants.
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