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U.S. Department of Health and Human Services


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Zerit (stavudine) Powder for Oral Solution, 1mg/mL February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009


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

Summary of Changes to Contraindications and Warnings


  • Hepatic Impairment and Toxicity
    • deletion... use with Didanosine and Hydroxyurea Based Regimen


  • Hepatic Impairment and Toxicity
    • ...this combination should be avoided


  • Use with Didanosine- and Hydroxyurea-Based Regimens
    • ...explaining the potential hepatoxicity, pancreatitis, and peripheral neuropathy with didanosine and hydroxyurea was revised and moved from the Adults subsection to Observed During Clinical Practice


  • What are the possible side effects of ZERIT?
    • Deletion Zerit, didanosine, and hydroxyurea combination
    • Deletion of “with or without hydroxyurea” in the subsection Pancreatitis