New black box warnings added to HIV drugs

fda logo New black box warnings added to HIV drugsAbacavir, a type of drug used to slow the progression of the human immunodeficiency virus (HIV) infection carries updated black box warnings, the most serious warning issued by the Food and Drug Administration (FDA) reserved for drugs in which there is a reasonable probability that the medication can cause serious health consequences or death.

One of the boxed warnings involves serious and sometimes hypersensitivity reactions with multiple organ involvement. The listing warns “NEVER restart (brand name drug) or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.”

Abacavir also carries a new boxed warning for lactic acidosis (low pH in body tissues and blood) and severe hepatomegaly (liver enlargement) with steatosis, (fatty liver) which in some cases has been fatal.

The updated boxed warnings were added to medications that contain the active drug ingredient abacavir, such as the brand names Ziagen, Trizivir, Epzicom and Triumeq. Trizivir, which combines abacavir with the medications lamivudine and zidovudine, also contains new boxed warnings for hematologic toxicity, myopathy and exacerbations of Hepatitis B. Epzicom, a combination of abacavir and lamivudine, and Triumeq, which combines abacavir with dolutegravir and lamivudine, also have a new boxed warning for exacerbations of Hepatitis B.

Another HIV treatment, Combivir, which contains lamivudine and zidovudine, does not warn of hypersensitivity reactions but does include warnings for hematologic toxicity, lactic acidosis and severe hepatomegaly with steatosis, exacerbations of Hepatitis B, as well as Myopathy, a disease of the muscle tissue.

Source: FDA