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FDA Revises Label for the HIV Drug Didanosine

Warning and Precautions revision addresses risk of non-cirrhotic portal hypertension

MONDAY, Feb. 1 (HealthDay News) -- In patients with HIV, use of Videx or Videx EC (didanosine) may increase the risk of non-cirrhotic portal hypertension, according to a Safety Announcement released Jan. 29 by the U.S. Food and Drug Administration, which has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication.

The FDA's action was prompted by 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosine, four of whom died and three of whom required liver transplantation.

The FDA encourages physicians to inform their patients about the clinical benefits and potential risks, including non-cirrhotic portal hypertension, associated with didanosine. The agency also recommends careful monitoring of patients prescribed didanosine for the development of portal hypertension and esophageal varices.

"FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient," state the authors of the Safety Announcement.

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