Annotation of U.S. Food and Drug Administration (FDA) label information
for dapsone
and G6PD
Summary
The FDA-approved label for dapsone gel provides a precautionary warning that G6PD deficient individuals may be at an increased risk of hemolytic adverse reactions, as oral dapsone treatment is associated with dose-related hemolysis and hemolytic anemia in these individuals. This enzyme deficiency is due to underlying genetic variants in the G6PD gene and can be tested for by enzyme activity or genetic tests.
Annotation
Dapsone gel (Aczone) is indicated for the topical treatment of acne vulgaris. Although the Dapsone drug label does not specifically mention genetic testing, the drug label highlights that G6PD deficient individuals may be more at risk of hematological adverse effects, though no evidence of hemolysis or anemia was observed when treated with the gel form of dapsone. Oral dapsone is associated with hemolysis and hemolytic anemia in G6PD deficient individuals. G6PD deficiency is a condition caused by variants in the G6PD gene that can be determined by enzymatic or genetic tests (see the G6PD VIP summary).
Excerpts from the dapsone gel (Aczone) drug label:
Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs...There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE Gel, 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE Gel developed laboratory changes suggestive of mild hemolysis.
WARNINGS AND PRECAUTIONS
Hematological Effects: Some subjects with G6PD deficiency using ACZONE Gel developed laboratory changes suggestive of mild hemolysis. (5.1)(8.6)
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the and Dapsone gel drug label.
Please note that the drug label for dapsone tablets available on the DailyMed website also precautions use of dapsone in patients with methemoglobin reductase (CYB5R3) deficiency or Hemoglobin M, both caused by underlying genetic variants, see the Dapsone tablet drug label.
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