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Medication in Pregnancy

Colesevelam in pregnancy

Colesevelam is a bile-acid sequestrant that is not absorbed in the gastrointestinal tract and is therefore not likely to be teratogenic, however they can bind and impede the absorption of fat-soluble vitamins. BNF advice is that supplements of vitamins A, D, K, and folic acid may be required when treatment is prolonged.

The Summary of Products Characteristics (SPC) for Cholestagel states 'Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Reproduction studies have been conducted in pregnant rats and rabbits. 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 . In rats, doses >30 times the MHD caused vitamin K deficiency and haemorrhage, but the absorption of fat-soluble (A, D, E, and K) vitamins was not significantly impaired.

Only one report was found with the use of colesevelam in humans. A 2012 report described five women with familial hypercholesterolemia, treated with colesevelam for 2 months before their planned pregnancies at a dose of 1950 mg/day . Two of the women discontinued colesevelam less than 4 weeks into their pregnancies, and the other three patients continued with the medication for the duration of pregnancy. All five births were described as full term and healthy. (Eapen DJ, Valiani K, Reddy S, Sperling L. Management of familial hypercholesterolemia during pregnancy: case series and discussion. J Clin Lipidol 2012;61:88–91.)

In conclusion, animal studies and limited human data show no increase in the risk of congenital anomalies. However, fat-soluble vitamin deficiency, especially vitamin K, is a potential complication if this agent is used during pregnancy.

This information was also requested to UK Teratology Information Service (UKTIS) do not have additional information.