Label Changes for:

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

February 2009

Changes have been made to the WARNINGS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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.


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
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