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Zonegran Label Revision Recommends Monitoring For Decreased Sweating

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Executive Summary

Patients on Elan's anticonvulsant Zonegran should be closely monitored for decreased sweating and increased body temperature, the company said in a "Dear Doctor" letter

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J&J Topamax Letter Recommends Monitoring For Decreased Sweating

A warning added to Johnson & Johnson's anti-convulsant Topamax (topiramate) is in line with a label revision for Elan's anti-convulsant Zonegran stating that patients should be closely monitored for decreased sweating and increased body temperature

J&J Topamax Letter Recommends Monitoring For Decreased Sweating

A warning added to Johnson & Johnson's anti-convulsant Topamax (topiramate) is in line with a label revision for Elan's anti-convulsant Zonegran stating that patients should be closely monitored for decreased sweating and increased body temperature

Zonegran Postmarketing Skin/Renal AEs To Be Considered Unlabeled Events

Elan should consider any postmarketing reports of allergic, skin, blood disorder and renal reactions with its new antiepileptic Zonegran to be unlabeled events, FDA told the company.

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