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Safety evaluation of the use of calcineurin inhibitor to prenatal and postpartum women in Japan from a health administrative database.
Journal of Neonatal-perinatal Medicine 2023 September 23
BACKGROUND: To investigate the use of calcineurin inhibitors (CNIs) in pregnant Japanese women and to evaluate their safety in infants.
METHODS: Data were extracted from the claims database of the Japan Medical Data Center. The prevalence of CNIs was evaluated 180 days before pregnancy onset, during pregnancy, and at 180-day postpartum. We investigated the characteristics of the infants, including the presence of major malformations and their diagnoses, for 1 year after birth.
RESULTS: A total of 80,049 pregnancies in 91,865 women were included. Fifty-three women were prescribed CNIs between 180 days before pregnancy and at 180-day postpartum; 35 of the 53 women were prescribed the drugs during pregnancy, and 10 of their infants were born preterm. Three were diagnosed with major congenital malformations, such as patent ductus arteriosus. Six preterm infants presented with infant respiratory distress syndrome.
CONCLUSIONS: No congenital anomalies were clearly attributable to the use of CNIs during pregnancy.
METHODS: Data were extracted from the claims database of the Japan Medical Data Center. The prevalence of CNIs was evaluated 180 days before pregnancy onset, during pregnancy, and at 180-day postpartum. We investigated the characteristics of the infants, including the presence of major malformations and their diagnoses, for 1 year after birth.
RESULTS: A total of 80,049 pregnancies in 91,865 women were included. Fifty-three women were prescribed CNIs between 180 days before pregnancy and at 180-day postpartum; 35 of the 53 women were prescribed the drugs during pregnancy, and 10 of their infants were born preterm. Three were diagnosed with major congenital malformations, such as patent ductus arteriosus. Six preterm infants presented with infant respiratory distress syndrome.
CONCLUSIONS: No congenital anomalies were clearly attributable to the use of CNIs during pregnancy.
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