Safety risk associated with HIV drug

The FDA said Videx (didanosine) is an antiretroviral medicine first approved in 1991, while Videx EC is a delayed-release version of Videx. Videx/Videx EC is used in combination with other antiretroviral medicines to treat human immunodeficiency virus infection in children and adults.

FDA officials said 42 cases of non-cirrhotic portal hypertension were reported during an 18-year period among patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

"Non-cirrhotic portal hypertension occurs when blood flow in the portal vein -- a major vein in the liver -- slows down and leads to severely enlarged veins in the esophagus," the FDA said. "These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding."

Officials said the Videx and Videx EC product labels have been revised to help ensure health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks.

Videx/Videx EC is marketed by Bristol-Myers Squibb of Princeton, N.J.

Copyright 2010 United Press International, Inc. (UPI).