Females should be warned of the potential adverse effects on the fetus should pregnancy occur while taking butalbital; acetaminophen; caffeine.
Each component crosses the placenta; available data are insufficient to inform a drug-associated risk for major birth defects and miscarriage from use of these products during pregnancy; animal studies have not been performed. Barbiturates have been associated with risks during pregnancy.
There are reports of physical abnormalities in infants correlating to exposure to barbiturates in utero. Additionally, a retrospective study revealed that in utero exposure to barbiturates was associated with intelligence deficits. Because neonatal coagulation defects have been reported within the first 24 hours in neonates born to epileptic mothers receiving other barbiturates, hemorrhagic disease in the newborn is theoretically possible after chronic in utero exposure to butalbital. If a mother used butalbital late in pregnancy, neonates should be carefully observed for signs of ventilatory depression, particularly if the infant is premature.
Repeated use of butalbital during the third trimester can also cause physical dependence in the neonate. Chronic barbiturate exposure in utero may result in an acute withdrawal syndrome in exposed neonates, including seizures and hyperirritability, with an onset up to 14 days after birth. Withdrawal seizures were reported in a 2-day-old male infant whose mother had taken a butalbital containing drug during the last 2 months of pregnancy.
Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms. Neonatal arrhythmias (e.g., tachycardia, premature atrial contractions) and tachypnea have been reported when caffeine was consumed during pregnancy in amounts greater than 500 mg per day; caffeine withdrawal in the neonate after birth may account for some of these symptoms.
There is no established use for acetaminophen; butalbital; caffeine during labor or obstetric delivery.