Hypercholesterolemia : Pregnancy & Breastfeeding

Drugs	Pregnancy	Breastfeeding
Atorvastatin Simvastatin Rosuvastatin	·         Category X ·         Animal studies have failed to reveal evidence of teratogenicity ·         Use in women who are or may become pregnant is contraindicated ·         Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development.	·         Use is contraindicated ·         has been detected in human milk. ·         potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism
Ezetemibe	·         Category C ·         Animal studies have revealed evidence of increased incidences of abnormal skeletal findings at higher doses. ·         There are no controlled data in human pregnancy	·         Use should be avoided ·         Due to concern over disruption of infant lipid metabolism, other agents are preferred, especially while nursing a newborn or preterm infant.
Fenofibrate	·         Category C
Cholestyramine	·         Category C ·         not absorbed after oral administration, direct fetal harm is not expected. Impairment of absorption of fat soluble vitamins and other nutrients as well as effects of reduced lipid concentrations may be of concern ·         drug has been used successfully during pregnancy. ·         only be given during pregnancy when benefit outweighs risk	·         not absorbed after oral administration and therefore is not expected to be present in human milk ·         While adverse effects in the breast-feeding infant are unlikely, altered absorption of fat soluble vitamins and other nutrients by the mother may effect the integrity of the milk.
Colestipol	·         not  formally assigned by the FDA ·         Because colestipol is not absorbed after oral administration, direct fetal harm is not expected. ·         Impairment of absorption of fat soluble vitamins and other nutrients as well as effects of reduced lipid concentrations may be of concern
Colesevelam (bile acid sequestrant)	·         Category B ·         used only if clearly needed ·         Requirements for vitamins and other nutrients are increased during pregnancy, however, the effect of this drug on the absorption of fat-soluble vitamins has not been studied in pregnant women	·         Use is considered acceptable ·         nonabsorbable resin ·         does not enter the nursing mother's bloodstream, it will not reach the infant via breast milk.

Recommendation

• Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hypercholesterolemia therapy.
• FH women who are on statin therapy and anticipate becoming pregnant should stop statins three months prior to attempting to conceive
• For breastfeeding, use of lipid lowering drugs is for long-term maternal benefits and temporary interruption of therapy is not usually considered to significantly impact on maternal morbidity or mortality
• bile acid sequestrants, cholestyramine and colestipol are expected to be safe in breastfeeding because they are not absorbed from the maternal gastrointestinal tract. These would be the preferred options for breastfeeding mothers
• However, the possibility of maternal (and infant) deficiencies in fat-soluble vitamins should be considered.

References:

• www.drugs.com
• www.uptodate.com
• Safety of Statins in Breastfeeding. 2002. Drug Information Service at Christchurch Hospital