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U.S. Department of Health and Human Services

Safety

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Doribax (doripenem for injection)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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 AND PRECAUTIONS

  • Interaction of doripenem with valproic acid

 

ADVERSE REACTIONS

 

WARNINGS and PRECAUTIONS

  • Interaction with valproic acid
    • Due to a drug interaction, patients with seizure disorders controlled with valproic acid or sodium valproate will be at an increased risk for breakthrough seizures...

 

ADVERSE REACTIONS

  • Postmarketing Experience
    • neutropenia and leucopenia