Warning About Severe Liver Complications Added to Didanosine Labeling

Kate Traynor

BETHESDA, MD 01 February 2010—A notice from FDA dated January 29 warns clinicians about a rare but potentially deadly adverse hepatic event affecting patients who take the antiretroviral drug didanosine.

According to FDA, the agency has received reports of noncirrhotic portal hypertension in patients treated with Videx or Videx EC, didanosine products made by Bristol-Myers Squibb. Information about this risk has been added to the labeling (PDF) for didanosine.

The agency examined 42 reports of cases of noncirrhotic portal hypertension, including four fatal cases, that occurred after the approval of didanosine. The condition occurred "months to years" after the start of didanosine treatment, according to FDA.

Only three patients described in the case reports have fully recovered, and all three required liver transplantation, the agency stated.

FDA recommends that clinicians discuss with patients the risks of this and previously known adverse hepatic events associated with didanosine, including lactic acidosis, enlarged liver, and toxicity when the drug is used concomitantly with hydroxyurea.

Despite these risks, FDA stated that for certain HIV-infected patients, the clinical benefits of didanosine outweigh its potential risks. Patients who take the drug should be monitored for the development of portal hypertension and enlarged esophageal veins, which can occur with portal hypertension.

In addition to Videx and Videx EC, didanosine is also available as a generic product.