Safety Risk Associated with HIV Drug Videx
In the United States, non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare. It occurs when blood flow in the major vein in the liver (the portal vein) slows down. This backed-up blood flow can lead to the development of severely enlarged esophageal veins called varices. Esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins. This combination can lead to ruptures of the esophageal varices which can result in serious bleeding and, in some cases, death.
The FDA first approved the antiretrovial medication Videx in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.
During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA’s Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.
The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.
The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.
Videx/Videx EC is marketed by Princeton, N.J.-based Bristol-Myers Squibb.
FDA News Release