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HIV patients taking the drug Videx and Videx EC (didanosine) have developed a rare but serious liver disorder called non-chrrhotic portal hypertension, the Food and Drug Administration warned.

Videx is an antiretroviral drug made by Bristol-Myers Squibb that was approved by the FDA in 1991 for treating patients with HIV, the infection that leads to AIDS. Videx EC is the delayed-release form approved in 2000. Both drugs are commonly used along with other antiretroviral medications to treat HIV infections in both adults and children.

Dozens of Cases Reported

Over a span of 18 months, there were 42 cases of non-chrrhotic portal hypertension reported in patients taking Videx or Videx EC, the FDA said. Four of those patients died as a result of internal bleeding or liver failure caused by the condition, the FDA said.

Non-cirrhotic portal hypertension occurs when blood flow in a major vein in the liver called the portal vein 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.

Due to reports of serious health complications in some users, the labeling for Videx and Videx EC has been revised to warn health care professionals and patients about the risks and the signs and symptoms of non-cirrhotic portal hypertension, the FDA said.

For many HIV patients, the benefits of Videx and Videx EC still outweigh the potential safety risks, officials said.

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