New label for
Baraclude includes warning for coinfected patients

The Food and Drug Administration has approved a revised label for Baraclude (entecavir) tablets and oral solution, adding safety information for patients simultaneously infected with HIV and hepatitis B, according to a press release posted online.

Entecavir--used to treat HBV--may cause patients to develop a resistance to certain HIV medications if they take the drug while not being treated for HIV. The label now includes the warning "Therapy with Baraclude is not recommended for HIV/HBV coinfected patients who are not also receiving highly active antiretroviral therapy (HAART)."

The use of Baraclude or any other medication containing entecavir by HIV-positive patients should be approved by a doctor. (The Advocate)