Didanosine gets labeling change
Put words in our mouth
Patients taking didanosine (Videx/Videx EC) have a newly recognized risk of non-cirrhotic portal hypertension, the FDA notified health care providers last week.
The medication, which is used to treat HIV infection, has been found to be associated with the liver problem based on reports submitted to the FDA's Adverse Event Reporting System. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, the FDA has revised the warning and precautions section of the drug label.
The 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, the agency said.