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U.S. Department of Health and Human Services

Safety

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Aczone (dapsone) Gel, 5%


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Hematological Effects
  • Peripheral Neuropathy

DRUG INTERACTIONS

  • Topical Benzoyl Peroxide

USE IN SPECIFIC POPULATIONS

  • G6PD Deficiency

PATIENT PACKAGE INSERT

  • What should I tell my doctor before using Aczone Gel?
    • ...You and your doctor will need to decide if Aczone is right for you.
  • What are the possible side effects of Aczone Gel?
    • ...When the active ingredients of Aczone Gel (called dapsone) is taken orally as a pill...

WARNINGS AND PRECAUTIONS

Hematological Effects

Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia...

Peripheral Neuropathy

Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical Aczone Gel, 5% treatment.