FDA Issues Warning For BMS Hepatitis B Drug Entecavir

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BMS Hepatitis B Drug Entecavir

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FDA on Thursday issued a warning that Bristol-Myers Squibb'shepatitis B drug entecavir might increase the likelihood of developingresistance to antiretroviral drugs among people coinfected with HIV, Reutersreports. The agency also added a black box warning to the drug's label.BMS -- which manufactures and sells entecavir under the brand nameBaraclude -- in a letter to physicians wrote that people coinfectedwith hepatitis B and HIV should not take entecavir unless they aretaking standard antiretrovirals. According to the warning, drugresistance can develop if a person is not being treated for HIV.

Thewarning also said that HIV testing should be offered to any person whoconsiders taking entecavir (Reuters, 8/16). There are morethan four million people worldwide living with both hepatitis B and HIVwho need treatment for hepatitis B but have not started antiretrovirals(Kaiser Daily HIV/AIDS Report, 3/2)

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.

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