Background and design: Psoralen photochemotherapy (PUVA) may carry a risk of mutagenesis and teratogenesis. Using a medical birth registry and other health registries, infants born to women who had been treated with PUVA were identified. Exposure information was obtained from treating hospitals and from the license-granting agency. A total of 504 infants were born of pregnancies occurring after PUVA treatment, and 689 infants were born of pregnancies occurring before such treatment. In another 14 cases, treatment occurred during pregnancy.
Results: No increase in infant or child mortality or in the presence of congenital malformations could be seen after PUVA treatment. There was a marked increase in low-birth-weight infants when pregnancy occurred after treatment, and this is probably not explained by maternal smoking, but could be an effect of the underlying disease.
Conclusions: The theoretical mutagenic and teratogenic effect of PUVA treatment apparently does not carry any significant risk for abnormal delivery outcome.