Risk of non-cirrhotic portal hypertension in patients using Didanosine

USA. The US FDA has alerted health-care professionals and patients about cirrhotic portal hypertension in patients using didanosine. Didanosine is used to treat human immunodeficiency virus (HIV) infection. The US FDA has received 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosine with 4 deaths in those reported cases. The Agency explains that the cause of death in the four patients was due to:

• -  Haemorrhage from esophageal varices in two patients
• -  Progressive liver failure in one patient and
• -  A combination of multi-organ failure, cerebral haemorrhage, sepsis and lactic acidosis in

  one patient.

  Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C., the US FDA has concluded that there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, the Agency has revised the warning and precautions section of the didanosine label to include information about non-cirrhotic portal hypertension. Didanosine already has a boxed warning for lactic acidosis and hepatomegaly with steatosis.