Pregnancy Outcomes Following Maternal Fenofibrate Exposure

Fenofibrate is a fibric acid derivative used in the management of severe hypertriglyceridemia, a condition that may lead to serious maternal and fetal complications during pregnancy. However, evidence regarding the safety of fenofibrate exposure in pregnancy remains extremely limited, and the available human data are largely restricted to isolated case reports. The aim of this study was to evaluate pregnancy outcomes of women who consulted a university teratology information service (TIS) due to fenofibrate exposure during pregnancy. The data for this retrospective case series include consultation records and follow-up interviews of pregnant women who consulted the TIS at Marmara University Hospital due to fenofibrate exposure between 2012 and 2025. Eleven pregnancies with fenofibrate exposure were identified, and pregnancy outcomes were available for 10 pregnancies. Six pregnancies resulted in live births and four resulted in stillbirth. Due to one twin pregnancy, a total of 11 infants were recorded, including seven live-born and four stillborn infants. No major congenital malformations were identified among live-born infants. One child was reported to have been diagnosed with autism during follow-up. Although the proportion of stillbirths in this series appears higher than expected, most affected pregnancies were complicated by significant maternal comorbidities, including severe hypertriglyceridemia, diabetes mellitus, hypertension, and acute pancreatitis, which are known risk factors for adverse pregnancy outcomes. Therefore, the observed stillbirths may be related to underlying maternal disease rather than fenofibrate exposure. Overall, the findings of this case series do not suggest a clear teratogenic signal associated with maternal fenofibrate exposure during pregnancy.