Does fenofibrate (Fibric acid derivative) affect fetal development during pregnancy?

From the Guidelines

Fenofibrate should be avoided during pregnancy due to potential risks to fetal development, as recommended by the most recent guidelines 1. The primary concern with fenofibrate use in pregnancy is its potential impact on fetal development, particularly given its mechanism of action affecting lipid metabolism.

• Animal studies have demonstrated adverse effects on embryo-fetal development at doses similar to human therapeutic doses, including skeletal abnormalities and reduced fetal weight.
• While human data is limited, the potential risks outweigh benefits in most cases, leading to a recommendation to avoid its use unless absolutely necessary and under close monitoring. Key considerations for managing high lipid levels during pregnancy include:
• Lifestyle modifications as the first line of treatment, such as dietary changes and appropriate exercise.
• For severe hypertriglyceridemia, alternative medications like omega-3 fatty acids might be considered to prevent pancreatitis.
• If a woman is currently taking fenofibrate and planning pregnancy, it is advisable to consult a healthcare provider about discontinuing the medication before conception or switching to a safer alternative, based on the latest standards of care 1. The biological concern is that fenofibrate affects lipid metabolism and may interfere with the normal development processes that require precise lipid regulation for proper fetal growth and organ development, highlighting the need for caution and careful management of lipid levels during pregnancy 1.

From the FDA Drug Label

Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 160 mg daily, based on body surface area (mg/m2). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data) Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Fenofibrate use in pregnancy: The available data are insufficient to determine the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

• Animal studies: No evidence of embryo-fetal toxicity was observed at doses less than or equivalent to the maximum recommended clinical dose.
• Maternal toxicity: Adverse reproductive outcomes occurred at higher doses.
• Clinical use: Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 2, 2, 2.

From the Research

Fenofibrate and Fetus Development in Pregnancy

• The use of fenofibrate during pregnancy has been reported in several cases, with no significant damage to the developing embryo observed in some studies 3, 4.
• A case study published in 2012 reported a successful pregnancy in a patient who used fenofibrate during the first trimester, with no congenital malformation recorded and a healthy male infant delivered at 36 weeks of gestation 3.
• Another case study published in 2011 reported the use of fenofibrate in a woman with hypertriglyceridemia-induced pancreatitis at 32 weeks of gestational age, with no recurrence of pancreatitis during the pregnancy and a healthy neonate delivered at 35 weeks of gestation 4.
• However, it is noted that fenofibrate is not approved for the treatment of dyslipidemia during pregnancy, and its use should be considered only if the benefits outweigh the potential risk 5.

Potential Risks and Considerations

• The safety of fenofibrate use during pregnancy has not been extensively studied, and its potential effects on fetal development are not fully understood 5, 6, 7.
• Fenofibrate has been shown to induce hepatomegaly, peroxisome proliferation, and hepatic carcinomas in rodents, but this type of hepatotoxicity has not been observed in humans 6.
• The decision to use fenofibrate during pregnancy should be individualized, taking into account the potential risks and benefits, and should be made in consultation with a healthcare provider 5.