FDA announces risk for liver complications associated with didanosine
FDA officials have announced that didanosine (Videx/Videx EC, Bristol-Myers Squibb) may be linked to non-cirrhotic portal hypertension in a small proportion of patients with HIV who are being treated with the drug.
Stay connected - Sign Up for the E-mail News Wire!The FDA has reported that over an 18-year period, there have been four fatalities among 42 cases of non-cirrhotic portal hypertension in patients taking didanosine. The cause of death in those instances was bleeding or liver failure.
The labels for the two products have been revised to indicate the risk factors for and the signs and symptoms of non-cirrhotic portal hypertension.
The FDA evaluation concluded that the clinical benefits of the two medications in certain patients with HIV continue to outweigh potential safety risks.
