Studies on the Detection of Adverse Drug Reactions in the Newborn

Abstract

The effects of prenatal medications on newborn hemostasis were investigated in 43 infants by comparing accurate prenatal drug histories with clinical and laboratory studies done postpartum. Fourteen newborns exposed to aspirin during the week prior to birth were compared to 17 children whose mothers had not taken aspirin. Two potentially adverse drug reactions were detected. Platelet dysfunction (inhibition of collagen aggregation) and diminished factor XII (Hageman factor) activity were found in neonates born of mothers who had taken aspirin during the last week of pregnancy. In this group, bleeding was limited to one incident each of cephalhematoma, purpura, and transient melena. In the group not exposed to aspirin, hemorrhagic conjunctivitis developed in one infant on the second day of life. Until the clinical significance of these findings is more fully evaluated, it would seem prudent to restrict aspirin during the last month of gestation.