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U.S. Department of Health and Human Services


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Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets) September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified


  • Pediatric Use
    • Use of didanosine in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of didanosine in adult and pediatric patients [see Dosage and Administration (2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)]. Additional pharmacokinetic studies in pediatric patients support use of Videx EC in pediatric patients who weigh at least 20 kg.


The following language was added:

...Dispose of unused medicines through community take-back disposal programs when available or place Videx EC in an unrecognizable closed container in the household trash.