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International News
European Medicines Agency Recalls Roche Antiretroviral Viracept Because of Contamination

June 8, 2007

The European Medicines Agency on Wednesday recalled Roche's antiretroviral drug Viracept because of contamination, the AP/International Herald Tribune reports. 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 (AP/International Herald Tribune, 6/6). 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. According to the PA/Irish Examiner, methane sulfonic acid ethyl ester can cause cancer.

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 (PA/Irish Examiner, 6/7). According to London's Guardian, investigators are still 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, the Guardian reports.

The U.S., Canada and Japan are not affected by the recall, Roche said. Roger Pebody, treatment adviser at the Terrence Higgins Trust, said it is "essential that people who are taking [Viracept] go to their doctors immediately in the next day and work out with their doctor the best way to proceed." He added that switching medications will "pu[t] people under a lot of pressure, but you would not want to leave off one or two doses" of treatment. There are thousands of HIV-positive people across Europe who use Viracept as part of their treatment regimens, according to the Guardian. The drug also is used widely in Africa because Roche lowered its price on the continent in 2003 (Boseley, Guardian, 6/7).

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