Videx and Videx EC (Ididanosine), a medicine used to treat human immunodeficiency virus (HIV) infection, has been associated with a rare but serious complication in the liver known as non-cirrhotic portal hypertension, according to the Food and Drug Association (FDA) Drug Safety Communication. The FDA issued the warning to health care professionals and patients after receiving reports of non-cirrhotic portal hypertension through its FDA Adverse Event Reporting System, and has revised the didanosine drug label to include information about this risk.
Non-cirrhotic portal hypertension is a rare type of hypertension in the U.S. and is not caused by cirrhosis of the liver. It occurs when the blood flow in the major vein in the liver slows, leading to the development of severely enlarged esophageal veins in the gastrointestinal system. Hypertension increases the pressure of blood flow in these veins, which may break open, causing bleeding and, in some cases, death.
Post-marketing of didanosine has resulted in 42 cases of non-cirrhotic portal hypertension following the use of didanosine alone or in combination with other antiviral drugs. Four of the 42 patients who developed the condition died. Other liver adverse events reported included lactic acidosis, hepatomegaly with steatosis, and liver failure.
Didanosine works to reduce the of HIV and helps the body maintain its supply of immune cells that are important in fighting HIV and other infections. The FDA believes certain patients with HIV may still benefit from didanosine, and urges patients to weigh risks and benefits with their health care professional, as this should be an individual decision.