Regulatory Actions
European Medicines Agency announces recall of Viracept
Published in Medical Letter on the CDC and FDA, July 1st, 2007
The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept (nelfinavir), an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of 3 years of age and older. As a consequence, the product is being recalled from the European Union markets, with immediate effect.
Roche has identified the presence of an unexpected contaminant ethyl mesylate (also known as methane sulfonic acid ethylester) in some batches of Viracept. Ethyl mesylate is a known genotoxic substance (harmful to DNA). The level of risk to patients...
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