Table 4.

Guidelines and recommendations for the use of autoimmune blistering disease treatments during pregnancy and lactation.

Dermatologic Medications Commonly Used in AIBD		Pregnancy			Lactation
		FDA1	ADEC2	Recommendations (Evidence level3)	Recommendations (Evidence level3)
Corticosteroids	Topical	C	A, B3, C	Use mild to moderate over potent strengths (IB)	Ok for use on nipples, except for Class I (IV)
	Oral	C	A	May increase the risk of oral clefts in first trimester (IV)	Use < 3 weeks (IV)
Anti-inflammatory	Dapsone	C	B2	Associated with hyperbilirubinemia/hemolytic anemia (IV)	Avoid in G6PD/hyperbilirubinemia (IV)
	IVIG	C	-	Limited evidence for safety (IV)	Can be used safely (III)
Systemic immunosuppressives	Mycophenolate mofetil	D	D	Contraindicated (III)	Avoid, likely enters milk (IV)
	Cyclosporin	C	C	Relatively safe in studies on transplants patients (III)	Evidence limited (IV)
	Azathioprine	D	D	Not recommended (III)	Monitor infant health (IV)
	Rituximab	C	-	Not recommended (III)	Minimal data, avoid (IV)
	Omalizumab	B	B1	Limited evidence for safety (IV)	Evidence limited (IV)

¹United States Food and Drug Administration (FDA) drug risk classifications

A: Clinical data show no evidence of risk to the fetus

B: Clinical data are limited or not available, but animal studies show no evidence of risk to the fetus, or clinical data show no evidence of risk to the fetus, but animal studies show adverse effects to the fetus

C: Clinical data are not available and animal studies are not available, or clinical data are not available, but animal studies show adverse effects to the fetus

D: Positive evidence of risk to the fetus from clinical data

X: Contraindicated based on animal studies or clinical data

²Australian Drug Evaluation Committee (ADEC) drug risk classifications

A: Extensive clinical experience in pregnant women and women of childbearing age has shown no increase in the frequency of malformations or other harmful effects on the fetus

B: Human data are lacking or inadequate. Limited use in pregnant women and women of childbearing age has shown no increase in the frequency of malformation or other harmful effects on the human fetus.

B1: Animal experiments have not given evidence of an increased incidence of fetal damage; similar to FDA category B

B2: Animal experiments are inadequate; similar to FDA category C

B3: Reproduction toxicity studies in animals have revealed an increased incidence of fetal damage, the significance of which is considered uncertain in humans; similar to FDA category C

C: Drugs which, owing to their pharmacologic effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.

D: Drugs which have caused, are suspected to have caused, or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.

X: Contraindicated in pregnancy

³Evidence levels

IA: Meta-analysis of randomized controlled trials

IB: Randomized controlled trials

II: Nonrandomized controlled studies and any quasi-experimental study

III: Comparative, correlational, case–control

IV: Expert reports/opinions or clinical reports

Adapted from Murase et al., 2014

Sources: Ahmed and Gurcan, 2011, Armenti et al., 1994, Butler et al., 2014, Carmichael et al., 2007, Chi et al., 2009, Hocking, 1968, Murase et al., 2014, Osadchy and Koren, 2011, Thornton and Bowe, 1989.