PREGNANCY RECOMMENDATION: Human Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: Limited Human Data—Probably Compatible
Except for a single case of overdose during labor, there is no evidence of embryo–fetal harm when scopolamine is used in pregnancy.
FETAL RISK SUMMARY
Scopolamine is an anticholinergic agent. A scopolamine transdermal system is used to prevent nausea and vomiting associated with motion sickness and recovery from anesthesia and surgery.
Reproduction studies in rats with daily IV doses did not observe fetal harm. A marginal embryotoxic effect was seen in rabbits at daily IV doses that produced plasma concentrations approximately 100 times the level achieved in humans with the transdermal system (1).
The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 309 of whom used scopolamine in the 1st trimester (2, pp. 346–353). For anytime use, 881 exposures were recorded (2, p. 439). In neither case was evidence found for an association with malformations. However, when the group of parasympatholytics was taken as a whole (2323 exposures), a possible association with minor malformations was found (2, pp. 346–353).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 27 newborns had been exposed to scopolamine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). One (3.7%) major birth defect was observed (one expected), but specific information on the malformation is not available. No anomalies were observed in six categories of defects, including cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias.
Scopolamine readily crosses the placenta (3). When administered to the mother at term, fetal effects include tachycardia, decreased heart rate variability, and decreased heart rate deceleration (4–6). Maternal tachycardia was comparable to that with other anticholinergic agents, such as atropine or glycopyrrolate (7).
Scopolamine toxicity in a newborn has been described (8). The mother had received six doses of scopolamine (1.8 mg total) with several other drugs during labor. Symptoms in the female infant consisted of fever, tachycardia, and lethargy; she was also “barrel chested” without respiratory depression. Therapy with physostigmine reversed the condition.
In a clinical study in women undergoing cesarean section, a scopolamine transdermal system was used with epidural anesthesia and opiate analgesia and no evidence of CNS depression was observed in the newborns (1).
No reports of adverse effects secondary to scopolamine in breast milk have been located. The drug is excreted into breast milk (1). The American Academy of Pediatrics classifies scopolamine as compatible with breastfeeding (9).
1.Product information. Transderm Scop. Novartis Consumer Health, 2000.
2.Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
3.Moya F, Thorndike V. The effects of drugs used in labor on the fetus and newborn. Clin Pharmacol Ther 1963;4:628–53.
4.Shenker L. Clinical experiences with fetal heart rate monitoring of one thousand patients in labor. Am J Obstet Gynecol 1973;115:1111–6.
5.Boehm FH, Growdon JH Jr. The effect of scopolamine on fetal heart rate baseline variability. Am J Obstet Gynecol 1974;120:1099–104.
6.Ayromlooi J, Tobias M, Berg P. The effects of scopolamine and ancillary analgesics upon the fetal heart rate recording. J Reprod Med 1980;25:323–6.
7.Diaz DM, Diaz SF, Marx GF. Cardiovascular effects of glycopyrrolate and belladonna derivatives in obstetric patients. Bull NY Acad Med 1980;56:245–8.
8.Evens RP, Leopold JC. Scopolamine toxicity in a newborn. Pediatrics 1980;66:329–30.
9.Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 2001; 108:776–89.