The Pharmaceutical Journal
Vol 278 No 7458 p760
30 June 2007

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Contamination may lead to suspension of Viracept

Roche's anti-HIV medicine Viracept (nelfinavir mesilate) has been recommended for suspension by the European Medicines Agency.

The step follows the recall of all batches of the product earlier this month after the active ingredient from which they were prepared was found to be contaminated with the genotoxic substance ethyl mesilate (methane sulfonic acid ethyl ester) (PJ, 16 June, p694 and 23 June, p728). A meeting of toxicology experts has concluded that there are insufficient data to establish a toxic dose of ethyl mesilate in humans.

Roche has been asked to identify and follow up all patients exposed to contaminated product since March, all women ever exposed to Viracept during pregnancy and all children ever exposed to the product, including in utero exposure.