Dapsone (Aczone®)

Pregnancy

The use of dapsone has shown adverse events in animal studies however the amount of dapsone that is available in the bloodstream after topical application is lower than when dapsone is taken orally. Data on topical dapsone use in pregnancy in humans is lacking.

Category: C

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Yes (after oral dosing); unknown after topical use.

There are no adequate studies that have tested the risk of topical dapsone use during breastfeeding. Oral dapsone use while breastfeeding has been related with hemolytic anemia in infants, especially in infants with G-6PD deficiency.

The amount of dapsone that is available in the bloodstream after topical application is lower than when dapsone is taken orally so the risk of adverse effects is also lower.