Propofol Pregnancy and Breastfeeding Warnings
Propofol Pregnancy Warnings
Propofol has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm or impaired fertility due to propofol. There are no controlled data in human pregnancy. Propofol should only be given during pregnancy when benefit outweighs risk.
Propofol rapidly crosses the placenta and distributes into the fetus. Most investigators have reported no difference in the Apgar scores of infants exposed to propofol alone or compared with other anesthetics (i.e. thiopental with either enflurane or isoflurane) during Cesarean section. Propofol intravenous bolus doses of 2.5 mg/kg or continuous infusions no higher than 6 mg/kg/hour have resulted in no difference in neurological or respiratory evaluation scores. Higher doses (i.e. 9 mg/kg/hour) have been associated with depressed neurological scores. One study found significantly lower Apgar scores at 1 and 5 minutes in infants (n=20) exposed to propofol (2.8 mg/kg) versus thiopental (5 mg/kg). Five infants exposed to propofol had profound muscular hypotonus at birth and 5 minutes after birth. Infants exposed to propofol demonstrated central nervous system and neuromuscular depression 1 hour after birth, but not at 4 hours. Five infants exhibited irritability and crying at 1 hour, but not at 4 hours. Prolonged sedation (12 hours) in an infant delivered by Cesarean section has been reported. Although the reported results of propofol use during Cesarean section appear positive, the manufacturer does not recommend that it be used for obstetrical procedures.
Propofol Breastfeeding Warnings
The amount of propofol received by the infant during breast-feeding is negligible compared to the amount they would be exposed to during placental transfer. Many clinicians feel breast-feeding is safe for the infant after maternal administration of propofol. One group of women undergoing Cesarean section was given a mean dose of 2.55 mg/kg. Another group was given 2.51 mg/kg plus a mean infusion of 5.08 mg/kg/hour. Breast milk/colostrum samples were collected between 4 and 24 hours after delivery. Propofol concentrations varied between 0.048 mcg/mL and 0.74 mcg/mL. The highest levels occurred 4 to 5 hours after delivery. One small study has reported the pharmacokinetic data of five lactating women who underwent induction of anesthesia with propofol. In 24 hours of milk collection, an average of 0.027% (0.004% to 0.082%) of the maternal propofol was collected in the milk representing an average of 0.025% of the elimination clearance of the drug. The author of the study concluded that the amount of propofol excreted into the milk within 24 hours of induction of anesthesia provided insufficient justification to interrupt breast-feeding.
Propofol is excreted into human milk. The manufacturer recommends that propofol not be used during nursing because the effects of oral absorption of propofol in the infant are unknown.
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