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Updated: Apr 17, 2026

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants
Published on: March 6, 2018
Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study
Florelle Bellet1, Marie-Noëlle Beyens, Nathalie Bernard
1Centre Régional de Pharmacovigilance, Centre Hospitalo-Universitaire, Saint-Etienne, France.
This study found no increased risk of major malformations or miscarriage with embryonic aripiprazole exposure. However, increased prematurity and fetal growth issues were observed, warranting further research on aripiprazole
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Neonatal Medicine
Background:
- Aripiprazole is an atypical antipsychotic used to treat various psychiatric conditions.
- Understanding the reproductive safety of medications like aripiprazole during pregnancy is crucial for clinical decision-making.
- Previous data on aripiprazole's effects during embryogenesis is limited.
Purpose of the Study:
- To evaluate the risk of major malformations following aripiprazole exposure during the embryonic period.
- To assess risks of miscarriage, prematurity, fetal growth retardation, and maternal complications.
- To describe potential neonatal adverse effects associated with prenatal aripiprazole exposure.
Main Methods:
- A prospective cohort study was conducted between 2004 and 2011.
- Data were collected by French Pharmacovigilance Centres within the Terappel program and the Centre de Référence sur les Agents Tératogènes.
- Eighty-six pregnant women exposed to aripiprazole during embryogenesis were compared to 172 matched unexposed controls.
Main Results:
- No significant association was found between embryonic aripiprazole exposure and major malformations (OR 2.30) or miscarriage (OR 1.66).
- Significantly increased rates of prematurity (OR 2.57) and fetal growth retardation (OR 2.97) were observed in exposed newborns.
- Two cases of neonatal complications were reported in newborns exposed near delivery; interpretation is limited by short exposure duration.
Conclusions:
- The study did not demonstrate a significant link between embryonic aripiprazole exposure and major malformations.
- Increased rates of prematurity and fetal growth retardation warrant further investigation.
- More robust prospective studies are needed to fully elucidate the reproductive safety profile of aripiprazole.
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