Elan has written to healthcare professionals warning them that its drug Zonegran can raise temperatures and reduce sweating in children.
The drug, which is not approved for paediatric use, is prescribed for the treatment of epileptic seizures in adults but off-label use occurs.
By the end of last year, 38 cases of raised temperatures and decreased sweating had been reported in Japan over an 11-year period.
Two cases have been reported in the US in the drug's first year of sales.
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Elan declined to comment yesterday but analysts said the warning, which has been added to the drug's label and was posted on the Food and Drug Administration's website this week, was marginally negative but not hugely significant in the overall context of the company.
