Table 5.

Relevant data on the safety in pregnancy of PUVA therapy, systemic corticosteroids, and cyclosporine

Treatment	Summary of data
PUVA	• Psoralens known as mutagens
	• After 12.8 years of a prospective study, pregnancy outcomes were documented among women treated with PUVA (93 women with 159 pregnancies). Exposure to PUVA at the time of conception or during pregnancy occurred in 19%. There was no evidence that PUVA affects the outcome of pregnancies or increases the risk of major malformations or stillbirth.50
	• A study examined 504 and 689 infants born of pregnancies occurring after and before PUVA treatment, respectively, whereas in another set of 14 cases, treatment occurred during pregnancy. After PUVA treatment, there was neither an increased child mortality nor a higher frequency of congenital malformations. A marked increase in low-birth-weight infants was observed when pregnancy occurred after treatment (effect attributed to the underlying disease).51
Systemic corticosteroids	• I n a prospective study of 184 women exposed to prednisone in pregnancy, there was no statistical difference in the rate of major anomalies compared to control groups. A meta-analysis showed a marginally increased risk of major malformations after first-trimester exposure to corticosteroids and a 3.4-fold risk of oral cleft.52
	• An analysis of 83,043 primiparous women (1.7% of whom used inhaled or oral corticosteroids from 30 days before conception throughout the first trimester) showed no evidence of an association with the risk of congenital malformations in progeny.53
	• A previous report from the National Birth Defect Prevention Study (NBDPS), using data from 1997 to 2002, found an association with cleft lip and palate, but not cleft palate only. In contrast to previous results, a new analysis performed using the NBDPS data from 2003 to 2009 (with a study population more than doubled in size) showed no association between maternal corticosteroid use and cleft lip and palate in the offspring.54
Cyclosporine (CsA)	• I n a retrospective study of 629 pregnant transplanted women exposed to CsA at doses of 1.4–14 mg/kg/d from week 6 throughout pregnancy, no significant differences were observed with the general population in terms of the frequency of fetal death or congenital malformations. There was, however, an increased rate of premature birth (44.5%) and low birth weight (44.3%) in the group of exposed women.55
	• An analysis of 15 studies on the use of CsA in pregnant transplant recipients reported an increased rate of premature birth.56
	• An increase in birth defects was not detected among 392 pregnant transplant recipients treated with CsA (unknown dose and duration of treatment).57

Abbreviations: PUVA, psoralens and UVA; CsA, Cyclosporine A.