Pregnancy Outcomes Following Maternal Exposure to Pramipexole: A TERAFAR Case Series
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Deniz Ceyda Bakirli1,2,3, Ersan Horoz1,2,3, Cagri Caglayan Kuragi1,2,3
1Department of Pharmacology and Toxicology, Izmir Kâtip Celebi University Faculty of Medicine, Izmir, Türkiye.
Background:
To evaluate pregnancy outcomes following maternal pramipexole exposure using data from the Izmir Kâtip Celebi University Teratology Information, Training and Research Center (TERAFAR).
Methods:
Pregnant women exposed to pramipexole and referred to the TERAFAR between 2011 and 2025 were evaluated. Maternal demographic data, medical history, and exposure details were recorded at the initial visit; pregnancy outcomes and neonatal data were collected through postpartum telephone interviews. The primary outcome was the rate of major congenital malformations, while secondary outcomes included miscarriage, stillbirth, preterm birth, and low birth weight.
Results:
A total of 11 pregnancies were evaluated. Median maternal age was 36 years, and restless legs syndrome was the primary indication in 10 of the 11 pregnancies. The median daily dose was 0.25 mg. Of the 11 pregnancies, 10 resulted in live births and one ended in miscarriage. No major congenital malformations were observed. A minor congenital anomaly (infantile hemangioma) was detected in only one premature infant.
Conclusions:
In this case series, maternal exposure to pramipexole was not associated with a consistent pattern of congenital anomalies suggestive of a teratogenic signal. Given the clinical context, the minor anomaly observed (infantile hemangioma) is more likely attributable to prematurity and maternal factors than to pramipexole exposure. Given the small sample size, findings should be interpreted with caution but may inform individualized counseling of pregnant women with inadvertent pramipexole exposure. Further studies are warranted.
