FDA Issues Warning for BMS Hepatitis B Drug Entecavir

FDA on Thursday issued a warning that Bristol-Myers Squibb's hepatitis B drug entecavir might increase the likelihood of developing resistance to antiretroviral drugs among people coinfected with HIV, Reuters reports. The agency also added a black box warning to the drug's label. BMS -- which manufactures and sells entecavir under the brand name Baraclude -- in a letter to physicians wrote that people coinfected with hepatitis B and HIV should not take entecavir unless they are taking standard antiretrovirals. According to the warning, drug resistance can develop if a person is not being treated for HIV. The warning also said that HIV testing should be offered to any person who considers taking entecavir (Reuters, 8/16). There are more than four million people worldwide living with both hepatitis B and HIV who need treatment for hepatitis B but have not started antiretrovirals (Kaiser Daily HIV/AIDS Report, 3/2).

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