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Caution Regarding Nelfinavir Use in Children and Pregnant Women
The discovery of a potential carcinogen in nelfinavir has prompted new recommendations regarding use of this drug.
On September 10, 2007, Pfizer issued a letter warning clinicians about an impurity in the PI nelfinavir (Viracept). The drug has been found to contain ethyl methanesulfonate (EMS), a process-related chemical that is potentially carcinogenic in humans. The levels of EMS detected in Pfizer-manufactured nelfinavir are lower than the levels detected in Roche-manufactured nelfinavir, which was recalled recently from the European market. Nevertheless, the FDA, Pfizer, and the U.S. Department of Health and Human Services agree that pregnant women and children who are starting antiretroviral therapy should not be offered nelfinavir-containing regimens "until further notice." Children who are stable on the drug can continue to receive it, whereas pregnant women with alternative treatment options should be switched to another drug. The U.S. Department of Health and Human Services further recommends that nelfinavir be avoided in HIV-infected women who are planning to become pregnant.
— ACC Editors
Published in AIDS Clinical Care September 24, 2007