European Medicines Agency Addresses Viracept Recall; Recommends Suspending Marketing Authorization

June 28, 2007
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited's (Basel, Switzerland) "Viracept" (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing.

June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited’s (Basel, Switzerland) “Viracept” (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing. Ethyl mesilate is harmful to DNA.

The agency’s Committee for Medicinal Products for Human Use (CHMP) concluded on June 13 that there were insufficient data to establish which doses of ethyl mesilate might be toxic to humans and requested that Roche carry out animal studies to calculate this level more precisely. Preliminary results are expected by the end of 2007.

CHMP also asked the company to identify the group of patients exposed to the contaminated batches of Viracept so that the committee can follow up and monitor their situation. CHMP plans to monitor all patients exposed to high levels of the contaminant in batches released since March 2007, as well as all pregnant women and children ever exposed to Viracept, including those children exposed in utero.

The agency also recommended that the European Commission (Brussels, Belgium) suspend Viracept’s marketing authorization. Until the manufacturing issues are identified by CHMP and resolved, the drug will not be available to patients.