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Fenofibrate, a fibric acid derivative, is a lipid-regulating drug with actions on plasma lipids similar to those of bezafibrate. It decreases elevated triglyceride levels by increasing the activity of lipases that catabolize triglyceride-rich lipoproteins and decreasing LDL cholesterol levels. It also increases those of HDL cholesterol (AEMPS 2017, BGP 2015, Miller 1998). Oral administration once daily.
At the date of last update we found no published data in relation to lactation.
Its very high percentage of protein binding make its passage into milk unlikely.
Cholesterol levels are normally increased (by 40%) during pregnancy and lactation in healthy women (Lawrence 2016 p590). Milk cholesterol numbers are very stable even in hypercholesterolemic women and are not severely affected by diet or the mother's nutritional status, leading to the assumption that milk cholesterol is synthesized, at least in part, in the mammary gland (Lawrence 2016, p 289-90). Its normal concentration in breast milk varies from 30 mg/dL in colostrum to 10 - 20 mg/dL in mature milk. (Lawrence 2016 p98, 105 and 767)
It is unlikely that fibrates are capable of altering the lipid composition of milk.
If a fibrate is administered during lactation, it is advisable to choose those with a shorter half-life: Bezafibrate, Gemfibrozil.
It is advisable to follow a lipid-lowering diet and to practice regular physical activity daily, at least half an hour a day.
Cholesterol is necessary for the development of brain tissue, myelination of nerves and is the basis of many enzymes. Breastfed infants have higher plasma cholesterol levels than those fed artificial formulas and this would protect them against the consequences of hypercholesterolemia in adulthood. (Lawrence 2016 p108)
Infants fed formula substitutes ("artificial milks") do not receive cholesterol in their diet, as these products do not contain cholesterol(Lawrence 2016 p 109 and 215). The amount of cholesterol in breast milk that would remain after the hypothetical cholesterol reduction produced by the medication taken by the mother would still be much higher than that provided by the artificial formulas. (Holmsen 2017)
Discontinuing drug treatment of non-severe hyperlipidemias during the breastfeeding period is not likely to alter the long-term outcome of the disease, especially when breastfeeding can be considered therapeutic. (Lawrence 2016, p. 393)
It seems wise to advise mothers with severe hyperlipidemias to continue medication during lactation. Mothers with moderately high triglyceride and/or cholesterol levels can discontinue drug treatment during the lactation period by monitoring their low density lipoproteins (LDL) and triglyceride levels.
For considerations on the appropriateness of lipid-lowering treatment during lactation see Maternal hyperlipidemia, hypercholesterolemia, hypertriglyceridemia.
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