Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension

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> Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal

Hypertension

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> Audience - HIV/AIDS, Infectious Disease healthcare professionals

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> FDA notified healthcare professionals and patients about a rare, but serious,

complication in the liver known as non-cirrhotic portal hypertension in patients

using Videx or Videx EC (didanosine), a medication used to treat human

immunodeficiency virus (HIV) infection. FDA became aware of cases of

non-cirrhotic portal hypertension through adverse event reports submitted to

FDA's Adverse Event Reporting System. 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. Because of the potential

severity of portal hypertension, including death from hemorrhaging esophageal

varices, FDA has revised the Warning and Precautions section of the didanosine

drug label to assure safe use of the medication. 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.

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> Read the complete MedWatch 2010 Safety summary including a link to the Drug

Safety Communication, at:

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm199343.htm

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