January 29, 2010
Videx and Videx EC labeling revised to include risk of non-cirrhotic portal hypertensionThe FDA has notified healthcare professionals and patients that the use of Videx or Videx EC (didanosine, from Bristol-Myers Squibb) may cause non-cirrhotic portal hypertension, a rare but serious complication. Based on the number of well-documented cases received by the FDA and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, the FDA concludes there is an association between use of didanosine and the development of non-cirrhotic portal hypertension.
Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, the FDA has revised the Warning and Precautions section of the Videx and Videx EC drug label to assure safe use of the medication. The FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks.
Videx and Videx EC are indicated for the treatment HIV-1 infection.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm.