Probucol

 Risk Factor: BM
 Class: ANTILIPEMIC AGENTS

Contents of this page:

Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers

Fetal Risk Summary

Probucol is used to lower serum cholesterol concentrations. In animal reproductive tests, probucol given during organogenesis to pregnant rats (up to 1000 mg/kg) and rabbits (administered unspecified amounts) produced no adverse fetal effects (1). The manufacturer reports a similar lack of evidence of fertility impairment or fetal harm in pregnant rats and rabbits given up to 50 times the human dose (2).

To our knowledge, only one source has described the use of probucol in human pregnancy. In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 11 newborns had been exposed to probucol during the 1st trimester (3). Two other infants were exposed after the 1st trimester. No congenital malformations were observed in the 13 infants.

Breast Feeding Summary

No human data are available. The manufacturer states that probucol is excreted into the milk of lactating animals (2), but specific data were not provided. Because of this, excretion into human milk should be expected.

References

1. Molello JA, Thompson DJ, LeBeau JE. Eight year toxicity study in monkeys and reproduction studies in rats and rabbits with a new hypocholesterolemic agent, probucol (abstract). Toxicol Appl Pharmacol 1979;648:A98. As cited in Shepard TH. Catalog of Teratogenic Agents. 7th ed. Baltimore, MD: Johns Hopkins University Press, 1992:327.
2. Product information. Lorelco. Marion Merrell Dow, 1994.
3. Rosa F. Anti-cholesterol agent pregnancy exposure outcomes. Presented at the 7th International Organization for Teratogen Information Services, Woods Hole, MA, April 1994.