August 7, 2007

Europe Suspends Viracept Sales

The European Commission temporarily suspended Roche’s license to sell the protease inhibitor Viracept (nelfinavir) in the European Union today, after the company voluntarily recalled the drug due to contamination in some batches found in early June, according to Reuters Alertnet.

The commission acted on the July 21 recommendation of the European Medicines Agency (EMEA) to suspend the marketing license until the company could show it has resolved the problem that caused higher than normal levels of methane sulfonic acid ethylester in their 250mg tablets and powder. High levels of the chemical are said to cause cancer and damage DNA.

Reuters reported that the African nation Zambia also banned the drug on July 10. But there have been no similar reports of contamination in the United States, Canada or Japan, where Pfizer manufactures Viracept.