Videx/Videx EC (didanosine) Associated with Serious Liver Disorder

Washington, DC: The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection. Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx.

Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged esophageal veins (varices) in the gastrointestinal system. Because esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins, esophageal varices can break open. This can result in serious bleeding and, in some cases, death.

The FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System (AERS). Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.

Of the 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosine the duuration of didanosine treatment ranged from months to years before development of non-cirrhotic portal hypertension. Definitive cases of non-cirrhotic portal hypertension were confirmed by biopsy and had no alternative etiology for the diagnosis.

There were four deaths total in the 42 reported cases. The cause of death in the four patients was due to, hemorrhage from esophageal varices in two patients; progressive liver failure in one patient; and a combination of multi-organ failure, cerebral hemorrhage, sepsis, and lactic acidosis in one patient.

The only patients who have been reported as fully recovered are three non-cirrhotic portal hypertension patients who received a liver transplant.

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Last updated on Mar-15-10