Didanosine Associated With Noncirrhotic Portal Hypertension

Emma Hitt, PhD

Disclosures

January 29, 2010

January 29, 2010 — Didanosine (Videc, VidecEC, Bristol Myers-Squibb) is associated with noncirrhotic portal hypertension, and as a result the label is being updated to include this information, the US Food and Drug Administration (FDA) announced today.

"FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System," states an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug."

A total of 42 postmarketing cases of noncirrhotic portal hypertension have been reported; of those, 4 patients died. Deaths were associated with hemorrhage from esophageal varices in 2 patients; progressive liver failure in 1 patient; and multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis in 1 patient each. Only the 3 patients who received a liver transplant fully recovered. Duration of didanosine treatment ranged from months to years.

As a result of these findings, the FDA has revised the warning and precautions and the patient counseling information sections of the didanosine drug label to include a section on noncirrhotic portal hypertension.

The FDA recommends that healthcare providers discuss with patients the clinical benefits and potential risks of didanosine treatment, including the risk for noncirrhotic portal hypertension. They should also continue to monitor patients for the development of portal hypertension and esophageal varices.

The FDA maintains that the clinical benefits of didanosine "for certain patients with HIV continue to outweigh its potential risks." The agency recommends that clinicians and patients make the decision to use didanosine on a case-by-case basis.

Didanosine currently has a boxed warning for lactic acidosis and hepatomegaly with steatosis. In addition, didanosine has been associated with the development of liver toxicity when used in combination with other antiretroviral agents.

More information is available on the FDA's MedWatch Web site.

Adverse events related to didanosine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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