Annotation of Health Canada Santé Canada (HCSC) label information
for dapsone
and G6PD
Summary
The product monograph for dapsone (ACZONE) notes that oral dapsone treatment can result in hemolysis and hemolytic anemia, particularly in patients who are glucose-6-phosphate dehydrogenase (G6PD)-deficient. However, for this topical formulation of the drug, a study showed no clinically relevant cases of hemolysis or anemia in G6PD-deficient individuals.
Annotation
Excerpts from the dapsone (ACZONE) product monograph:
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. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern and Mediterranean ancestry.
In patients treatment with ACZONE, including patients who were G6PD deficient, there was no evidence of clinically relevant hemolysis or anemia. A randomized, double-blind, vehicle-controlled, cross-over clinical study was conducted in G6PD-deficient patients with acne vulgaris to evaluate the risk of hemolysis and/or hemolytic anemia with ACZONE treatment. In this study 56 safety-evaluable patients showed no evidence of clinically relevant hemolysis or anemia. Some subjects with G6PD deficiency using ACZONE developed laboratory changes suggestive of mild hemolysis.
For the complete product monograph text with sections containing pharmacogenetic information highlighted, see the dapsone product monograph.
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