Rare cases of congenital anomalities including cleft palate, cleft lip, ventricular septal defect, patent ductus arteriosus,
and congenital heart defects have been reported in the infants of woman using
Prometrium for unapproved indications including the preventions of such outcomes. Studies in humans cannot rule out the possibility of harm. Therefore, Prometrium capsules should be used during pregnancy only if indicated.