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.