Roche To Establish Registries To Monitor Health of HIV-Positive People Exposed to Recalled Antiretroviral Viracept
Roche on Thursday said that it plans to establish patient registries to monitor the health of HIV-positive people who were taking the company's recently recalled antiretroviral drug Viracept, the Press Association reports (Moynihan, Press Association, 6/21).
The European Medicines Agency earlier this month recalled Viracept because of contamination. Roche in a statement said that it is recalling all batches of the drug in cooperation with EMA and Swissmedic, Switzerland's drug regulator, in Europe and other undisclosed countries. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities.
William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Investigators still are trying to determine what occurred in the Swiss plant where the drug is manufactured. It is believed that the contamination might have occurred in March and has affected supplies of the drug for three months (Kaiser Daily HIV/AIDS Report, 6/21).
The company said it is establishing the patient registries for HIV-positive people exposed to elevated levels of EMS, as well as pregnant women and all children who have ever been exposed to the drug, including those exposed in utero. Roche "take[s] the welfare of patients extremely seriously," Burns said, adding, "With the knowledge we have to date, we consider the risk to patients to be low; however, we want to be sure patients can be followed, and these registries will allow us to do just that" (Press Association, 6/21).