BUMETANIDE

Fetal Risk Summary

Bumetanide is a potent loop diuretic that is similar in action to furosemide; it shares the same indications and precautions for use during gestation as this latter diuretic (see also Furosemide). The drug is not teratogenic in rats, mice, hamsters, or rabbits (1,2). In rats, doses 3400 times the maximum therapeutic human dose (MTHD) had a slight embryocidal effect, produced fetal growth retardation, and increased the incidence of delayed ossification of sternebrae (2). In rabbits, which are more sensitive to the effects of bumetanide than other test species, doses 3.4 times the MTHD were slightly embryocidal (2). At doses 10 times the MTHD, an increased embryocidal effect was observed, as well as an increased incidence of delayed ossification of sternebrae (2).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 44 newborns had been exposed to bumetanide during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Two (4.5%) major birth defects were observed (two expected), both of which were cardiovascular defects (0.4 expected).

No published reports on the use of bumetanide in human pregnancy have been located, but the diuretic has been recommended for the treatment of the nephrotic syndrome occurring during pregnancy (3). However, diuretics are not recommended for the treatment of pregnancy-induced hypertension because of the maternal hypovolemia characteristic of this disease.

[*Risk Factor D if used in pregnancy-induced hypertension.]

Breast Feeding Summary

No data are available. Bumetanide and other diuretics should be used cautiously during nursing because they may suppress lactation.

References

1. McClain RM, Dammers KD. Toxicologic evaluation of bumetanide, a potent diuretic agent. J Clin Pharmacol 1981;21:543–54. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:92.
2. Product information. Bumex. Roche Laboratories, 1993.
3. Wood SM, Blainey JD. Hypertension and renal disease. In Wood SM, Beeley L, eds. Prescribing in pregnancy. Clin Obstet Gynaecol 1981;8:439–53.