A rare but serious liver disorder has been reported in some patients taking the HIV drug Videx (didanosine) and its delayed-release formulation, Videx EC, the Food and Drug Administration (FDA) said Monday.
FDA said 42 cases of non-cirrhotic portal hypertension have been reported in patients taking Videx/Videx EC during an 18-year period. "Non-cirrhotic portal hypertension occurs when blood flow in the portal vein, a major vein in the liver, slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding," FDA said. The condition has led to the death of four patients.
Marketed by Bristol-Myers Squibb, Videx, an antiretroviral, was approved by FDA in 1991 and is taken in combination with other HIV drugs. In its latest statement, FDA said the drug's clinical benefits in some patients continue to outweigh its potential safety risks. The labels of Videx/Videx EC have been revised to warn providers and patients about symptoms of the liver disorder.
For more information, visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199169.htm.