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U.S. Department of Health and Human Services

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Zerit (stavudine) Capsules, 15 mg, 20 mg, 30 mg and 40 mg 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

WARNINGS

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

WARNINGS

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

ADVERSE REACTIONS

  • 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

PATIENT PACKAGE INSERT

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