Risk Factor: B
Class: Antilipemic agents
Fetal Risk Summary
The anion exchange resin, colestipol, is used to bind bile acids in the intestine into a nonabsorbable complex that is excreted in the feces. The prevention of the systemic reabsorption of the bile acids lowers the total amount of cholesterol in the patient. Because less than 0.17% of a dose is absorbed systemically, it is not expected to cause fetal harm when administered during pregnancy in recommended doses (1).
In a reproductive study with rats and rabbits, doses up to 1000 mg/kg/day produced no adverse effects on the fetuses (2). No published or unpublished cases involving the use of colestipol during human pregnancy have been located. Rosa also reported finding no recipients of this drug in his 1994 presentation on the outcome of pregnancies following exposure to anticholesterol agents (3).
The actions of colestipol are similar to those of cholestyramine, another exchange resin (see also Cholestyramine). Because it is not absorbed into the systemic circulation, it should have no direct effect on the fetus. However, as with cholestyramine, prolonged use of colestipol may result in reduced intestinal absorption of the fat-soluble vitamins, A, D, E, and K. Because the interruption of cholesterol lowering therapy during pregnancy should have no effect on the long-term treatment of hyperlipidemia, the use of colestipol should probably be halted during gestation.
Breast Feeding Summary
Because colestipol is poorly absorbed (less than 0.17% of a dose) into the systemic circulation, its use by the lactating woman should have no direct effect on the nursing infant. Prolonged use of the exchange resin, however, may result in decreased maternal absorption of the fat-soluble vitamins, A, D, E, and K. The resulting deficiencies in the mother would lessen the amounts of these vitamins in her milk.
- Product information. Colestid. Pharmacia & Upjohn, 2000.
- Webster HD, Bollert JA. Toxicologic, reproductive and teratologic studies of colestipol hydrochloride: A new bile acid sequestrant. Toxicol Appl Pharmacol 1974;28:5765. As cited in Shepard TH. Catalog of Teratogenic Agents. 7th ed. Baltimore, MD:Johns Hopkins University Press, 1992:105.
- Rosa F. Anticholesterol agent pregnant exposure outcomes. Presented at the 7th International Organization for Teratogen Information Services, Woods Hole, MA, April 1994.