Fenofibrate Safety During Pregnancy
Fenofibrate should not be used during pregnancy as it is contraindicated due to limited safety data and potential risks to fetal development. 1
Evidence on Fenofibrate Use in Pregnancy
FDA Labeling and Regulatory Status
The FDA label for fenofibrate clearly states that there is "limited available data with fenofibrate use in pregnant women" which is "insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes." 1 The drug label specifically mentions that fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Guideline Recommendations
Multiple clinical guidelines provide specific recommendations against fenofibrate use during pregnancy:
The European Association for the Study of Liver (EASL) 2022 guidelines explicitly state: "Due to a lack of data, bezafibrate is not recommended during pregnancy." 2 This recommendation extends to other fibrates like fenofibrate.
The American Association for the Study of Liver Diseases (AASLD) 2021 guidance states: "Obeticholic acid and fibrate use cannot be recommended in pregnancy or lactation in women with PBC due to lack of safety data." 2
The 2023 EASL guidelines on liver diseases in pregnancy reiterate that while "fibrates have been used in pregnant women with hypertriglyceridemia after the first trimester, there are limited safety data. Thus, decisions about the use of fibrates should be individualized and based upon the severity of maternal disease." 2
Animal Studies and Human Data
Animal reproduction studies have shown mixed results:
According to the FDA label, at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure), increased fetal skeletal malformations were observed in rats. 1
In rabbits, aborted litters were observed at maternally toxic doses. 1
A study in mice found that high doses of fenofibrate induced significant postimplantation loss, indicating potential fetotoxic effects. 3
Limited human case reports show:
- A case of unplanned pregnancy with fenofibrate exposure during the first trimester that resulted in a healthy infant 4
- A case of successful use of fenofibrate for hypertriglyceridemia-associated pancreatitis at 32 weeks of gestation 5
However, these isolated cases are insufficient to establish safety.
Breastfeeding Considerations
The FDA label explicitly states: "Because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibrate and for 5 days after the final dose." 1
Alternative Approaches
For women requiring lipid management during pregnancy:
- Bile acid sequestrants are the only lipid-lowering drugs approved for use during pregnancy 6
- For cholestasis-associated pruritus in pregnancy, safer options include:
Management Algorithm for Lipid Disorders in Pregnancy
- First-line approach: Discontinue fenofibrate immediately upon pregnancy confirmation
- For necessary lipid management:
- Consider bile acid sequestrants as first-line therapy
- Monitor for vitamin K deficiency if using cholestyramine
- For severe hypertriglyceridemia with risk of pancreatitis:
- Consider specialist consultation for risk-benefit assessment
- Implement strict dietary control with low-fat diet
- Monitor triglyceride levels closely
Important Considerations
- Women taking fenofibrate should be advised to use effective contraception
- Preconception counseling should include discussion about discontinuing fenofibrate before attempting pregnancy
- If a woman becomes pregnant while taking fenofibrate, the medication should be discontinued immediately
- Patients should wait at least 5 days after the final dose of fenofibrate before breastfeeding 1
Despite isolated case reports of successful pregnancies with fenofibrate exposure, the overall evidence base is insufficient to recommend its use during pregnancy, and current guidelines and FDA labeling advise against it.