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Podcast for Healthcare Professionals: Serious Liver Disorder Associated with the Use of Videx/Videx EC

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Run Time 00:04:56

 

Welcome, my name is Mary Kremzner, a pharmacist in the Division of Drug Information. Today I am updating you about a serious liver disorder associated with the use of Videx or Videx EC.

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals about a rare, but serious adverse event in the liver, non-cirrhotic portal hypertension, associated with the use of didanosine, marketed as Videx and Videx EC, a delayed-release version of Videx.

Didanosine is an antiretroviral medication used to treat HIV infection.

Non-cirrhotic portal hypertension is rare in the United States and occurs when blood flow in the portal vein slows down. This slowed blood flow can lead to the development of esophageal varices. The increased pressure can cause the varices to break open resulting in serious bleeding and, in some cases, death.

FDA became aware of 42 cases of non-cirrhotic portal hypertension through the adverse event reports submitted to FDA's Adverse Event Reporting System (AERS). Based on these reports, FDA has revised the Warnings and Precautions section of the prescribing information.

Other liver adverse events such as lactic acidosis, hepatomegaly with steatosis, and liver failure have been reported with the use of didanosine alone and in combination with other antiviral drugs and are already included in the prescribing information.

Of the 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosine:

  • Twenty-six were males, 14 were females, and in two no gender was specified.
  • The ages ranged from 10 years to 66 years.
  • Duration of didanosine treatment ranged from months to years before development of non-cirrhotic portal hypertension.
  • Definitive cases of non-cirrhotic portal hypertension were confirmed by biopsy and had no alternative etiology for the diagnosis.

Medical interventions described in the reported cases included:

  • Banding/ligation of esophageal varices in 8 patients.
  • Transjugular intrahepatic portosystemic shunt (TIPSS) procedure in three patients.
  • Liver transplantation in 3 patients.

There were four deaths total in the 42 reported cases. The cause of death in the four patients was due to:

  • Hemorrhage from esophageal varices in two patients.
  • Progressive liver failure in one patient.
  • A combination of multi-organ failure, cerebral hemorrhage, sepsis, and lactic acidosis in one patient.

The only patients who have been reported as fully recovered are the three non-cirrhotic portal hypertension patients who received a liver transplant.

FDA recommends that Healthcare Professionals do the following:

  1. Be aware that didanosine use has been associated with the development of non-cirrhotic portal hypertension.
  2. Discuss with patients the clinical benefits and potential risks, including the risk of non-cirrhotic portal hypertension, with the use of didanosine.
  3. Continue to monitor patients for the development of portal hypertension and esophageal varices.
  4. Be aware that didanosine already has a Boxed Warning for lactic acidosis and hepatomegaly with steatosis.
  5. Didanosine in combination with other antiretroviral agents as well as hydroxyurea or ribavirin has been associated with the development of liver toxicity.

A causal association is difficult to determine from postmarketing reports alone. However, based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension.

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.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach us at the following email address: druginfo@fda.hhs.gov.

 

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