Fetal Risk Summary
This non-absorbed, polymeric, lipid-lowering agent binds bile acids to prevent their absorption. Because cholesterol is the sole precursor of bile acids, this action eventually results in the lowering of low-density lipoprotein (LDL) cholesterol levels in the blood. It is indicated, either alone or in combination with a HMG-CoA reductase inhibitor (atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, or simvastatin), as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (1). Because the drug is not absorbed, no direct embryo or fetal exposure will occur.
Reproduction studies have been conducted in pregnant rats and rabbits (1). Doses that were about 50 and 17 times, respectively, the maximum human dose based on body weight (MHD), revealed no evidence of fetal harm. In addition, no effect on rat fertility was seen at 50 times the MHD (1). In rats, doses greater than 30 times the MHD caused vitamin K deficiency and hemorrhage, but the absorption of fat soluble (A, D, E, and K) vitamins was not significantly impaired (1).
The effect of colesevelam on the absorption of vitamins and other nutrients from the gastrointestinal tract in pregnant women has not been studied (1). Fat soluble vitamin deficiency, especially vitamin K (see above), is a potential complication if this agent is used during pregnancy.
Breast Feeding Summary
No reports describing the use of colesevelam in lactation have been located. The drug is not absorbed after oral administration so no drug exposure of a nursing infant via breast milk will occur. However, maternal deficiency of fat soluble vitamins, especially vitamin K (see above), is a potential complication. This may result in lower fat soluble vitamin concentrations in milk because these vitamins are natural constituents of breast milk.
- Product information. Welchol. Sankyo Pharma, 2001.