Federal regulators are warning that the Bristol-Myers Squib HIV drug Videx appears to be linked to rare liver problems, known as non-cirrotic portal hypertension, which could be fatal for some users.
The Videx side effects warning was issued on January 29 by the FDA. The agency noted that it has received 42 adverse event reports among users of Videx and Videx EC involving the rare, but serious, liver disorder over the last 18 years. At least four of the patients died from bleeding or liver failure on Videx after developing the condition.
Videx (didanosine) is an antiretroviral drug marketed by Bristol-Myers Squib. It was first approved by FDA in 1991. In 2000, the FDA approved a delayed-release version called Videx EC. The drug belongs to a class of medications known as nucleoside analogues, and reduces the growth of HIV.
Non-cirrhotic portal hypertension is the result of restricted blood flow through a major vein in the liver. The blood backs up to veins in the esophagus, which become enlarge and distended. The enlarged veins can sometimes rupture, leading to serious bleeding and, potentially, death.
Despite the risk of Videx liver damage, the FDA says that the drug should stay on the market, because the benefits for HIV patients still outweigh the risks. The FDA is requiring new label warnings, as well as changes to the medication guide to alert users about the potential risk of the Videx side effects. The drug already has been known to cause liver toxicity when combined with some other antiretroviral medications, such as hydroxyurea and ribavirin.
The FDA recommends that doctors with patients taking Videx regularly monitor for signs of portal hypertension.