Didanosine and noncirrhotic portal hypertension
The U.S. Food and Drug Administration (FDA) announced that postmarketing surveillance has revealed a small number of cases of noncirrhotic portal hypertension in patients receiving didanosine (Videx and Videx EC). Forty-two cases have been identified, in both men and women, in both children and adults, and in patients with various durations of didanosine treatment (months to years). Complications have included variceal bleeding, liver failure, and death. Alternative causes of portal hypertension in these patients (eg, cirrhosis related to alcohol use or viral hepatitis) were excluded. The FDA warns that patients taking didanosine should be advised of the possible risk of noncirrhotic portal hypertension and that patients should be monitored (by history, physical examination, and laboratory evaluation) for early signs of portal hypertension. The Videx and Videx EC package labels now include this information.
more on didanosine References |