FDA is notifying healthcare professionals about cases of a rare but serious complication, non-cirrhotic portal hypertension, in patients taking Videx (didanosine) or Videx EC, to treat HIV infection.
Clinicians should monitor patients on Videx for portal hypertension and esophageal varices. They should also be aware that Videx has been associated with other hepatic effects, including lactic acidosis, hepatomegaly with steatosis, and liver failure.
FDA believes that for certain patients, the clinical benefits of Videx continue to outweigh its risks, and that the decision to use the drug must be made on an individual basis.
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