The Pharmaceutical Journal
Vol 271 No 7257 p39
12 July 2003

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New stroke warning for OTC products

Over-the-counter cough and cold products containing sympathomimetics can increase risk of stroke, researchers say.

They identified 22 patients with strokes associated with cough and cold products containing sympathomimetics from a register at a neurological centre in Mexico. Sixteen had received phenylpropanolamine, four pseudoephedrine, and two nasal decongestants. Doses varied between patients with some taking recommended doses and others excessive doses. For phenylpropanolamine, doses went from 50mg to 675mg and for pseudoephedrine from 60mg to 300mg.

Previous research suggested that stroke is associated with use of higher doses of sympathomimetics, particularly those used as appetite suppressants by women in America. This study suggests that an association exists between stroke and sympathomimetics in cough and cold preparations too.

The earlier data led to a reduction in the number of marketed products containing phenylpropanolamine in several countries. But the authors of the new research warn that an association also exists for other decongestants: "Although most [strokes] were related to phenylpropanolamine, stroke can also occur with the use of other sympathomimetics, particularly pseudoephedrine," they comment. "The relationship between stroke and pseudo- ephedrine was evident in four patients in our series including two cases by the ingestion of recommended doses."

Their research showed that stroke occurred after a single dose in 17 patients and after longer use in the others. Onset of stroke symptoms occurred between 30 minutes and 24 hours after exposure to sympathomimetics. High blood pressure was present in 90 per cent of patients on admission to hospital. Persistent or uncontrolled hypertension was present in eight cases, including three patients who had taken a single dose of sympathomimetic.

The study is published in Stroke (2003;34:1667).