Safety Alerts & Recalls

What does this mean?

Non-cirrhotic portal hypertension is a serious, but rare, side effect that has occurred in patients using didanosine. However, the FDA believes the benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. If you are taking didanosine or the brand name Videx or Videx EC, please review this new safety information with your doctor or other healthcare provider, especially if you have a history of cirrhosis (scarring of the liver) or other liver problems.

You should keep your appointments with your doctor so that you can be monitored for the development of portal hypertension. At home, you can watch for symptoms of portal hypertension. Contact your doctor right away if you experience gastrointestinal bleeding (black, tarry stools; blood in the stools; or vomiting of blood), unexplained weight gain, accumulation of fluid in the abdomen, confusion, or forgetfulness.

If you have any other questions about didanosine, Videx, or Videx EC, or if you think you may be experiencing side effects, please follow up with your doctor.

Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC)

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using didanosine (also marketed as Videx and Videx EC). Non-cirrhotic portal hypertension occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged veins in the gastrointestinal system which sometimes leads to serious bleeding complications.

The FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to the FDA's Adverse Event Reporting System (AERS). Based on these reports, the FDA has revised the didanosine, Videx, and Videx EC drug labels to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.

Didanosine is a medication used along with other drugs to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes AIDS. The brand name Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx.

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Source: FDA
Publication Date: 2010-01-29
Last Updated: 2010-01-29

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