The FDA has put a Black Box Warning on Bristol-Myers Squibb's hepatitis B drug Baraclude. A warning letter to doctors said that Baraclude should not be given to HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy because of potential for the development of HIV resistance. BMS recommends that HIV testing should be conducted in all hepatitis B virus patients before starting treatment with Baraclude.
- check out the release on the label change