Antihypertensive
PREGNANCY RECOMMENDATION: Limited Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: Limited Human Data—Probably Compatible
PREGNANCY SUMMARY
The limited human pregnancy experience and the absence of animal reproduction data prevent an assessment of the embryo–fetal risk. The data from one source suggest that avoiding exposure in the 1st trimester would be a wise choice.
FETAL RISK SUMMARY
The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 48 of whom had 1st trimester exposure to reserpine (1, p. 376). There were four defects with 1st trimester use. Although this incidence (8%) is greater than the expected frequency of occurrence, no major category or individual malformations were identified. For use anytime in pregnancy, 475 exposures were recorded (1, p. 441). Malformations included the following: microcephaly (7 cases); hydronephrosis (3 cases); hydroureter (3 cases); and inguinal hernia (12 cases) (1, p. 495).
Reserpine crosses the placenta. Use of reserpine near term has resulted in nasal discharge, retraction, lethargy, and anorexia in the newborn (2). Concern over the ability of reserpine to deplete catecholamine levels has appeared (3). The significance of this is not known.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 15 newborns had been exposed to reserpine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). No major birth defects were observed (one expected).
BREASTFEEDING SUMMARY
Reserpine is excreted into breast milk (4). No reports of adverse effects in a nursing infant have been located.
References
1.Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
2.Budnick IS, Leikin S, Hoeck LE. Effect in the newborn infant to reserpine administration ante partum. Am J Dis Child 1955;90:286–9.
3.Towell ME, Hyman AI. Catecholamine depletion in pregnancy. J Obstet Gynaecol Br Commonw 1966;73:431–8.
4.Product information. Serpasil. Ciba Pharmaceutical, 1993.