The US Food and Drug Administration (FDA) has confirmed four fatal cases of non-cirrhotic portal hypertension, a rare but serious liver disorder, in some HIV patients taking Videx/Videx EC (didanosine).
Videx is an antiretroviral medicine, developed by Bristol-Myers Squibb, that was first approved by the FDA in 1991 to treat HIV infection in children and adults in combination with other antiretroviral medicines.
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. Of these, four patients died from bleeding or liver failure after developing the condition.
A FDA evaluation has, however, concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks.
Videx and Videx EC product labels have been revised to help ensure that healthcare professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.
Videx EC is a delayed-release version of Videx approved in 2000.