FDA issues safety risk for HIV drug

ROCKVILLE, Md. A rare but serious liver disorder has been reported in some patients taking a drug used to treat HIV, the Food and Drug Administration said Monday.

The agency said some patients taking Bristol-Myers Squibb’s antiretroviral drug Videx (didanosine) and the extended-release formulation, Videx EC, had experienced non-cirrhotic portal hypertension, in which blood flow in the liver’s portal vein slows down and leads to severely enlarged veins in the esophagus. The enlarged veins, called esophageal varices, can then break open, causing serious and potentially fatal bleeding.

Over an 18-year period, 42 cases of the condition, including four deaths, have been reported in patients taking the drug. The FDA approved Videx in 1991 and Videx EC in 2000. Still, the agency said, the benefits of the drug outweigh the risks.

In a statement obtained by Drug Store News Monday, Bristol said it had updated the safety information for the drugs and created a risk evaluation and mitigation strategy, or REMS, which the agency had required.

“Bristol-Myers Squibb is committed to understanding both the efficacy and safety profiles of our medicines,” the company said in the statement.