Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study

• DOI: 10.1002/pds.3749
• Publication Date: 2015-02-13T10:25:46Z
• Authors: Florelle Bellet; Marie‐Noëlle Beyens; Nathalie Bernard; Delphine Beghin; Elisabeth Elefant; Thierry Vial
• Keywords: Aripiprazole

Abstract Purpose The main purpose of this study was to evaluate the risk major malformations after aripiprazole exposure during embryonic period. secondary purposes were assess miscarriage, prematurity, fetal growth retardation and maternal complications describe possible neonatal adverse effects. Methods We conducted a cohort using data prospectively collected by French Pharmacovigilance Centres participating Terappel program Centre de Référence sur les Agents Tératogènes between 2004 2011. exposed group consisted pregnant women embryogenesis, unexposed without or non‐teratogenic agents. Two patients, matched for age gestational at call, randomly selected each patient. Results Eighty‐six patients included in 172 group. Exposure not significantly associated with an increased rate (OR 2.30, 95%CI 0.32–16.7) miscarriage (1.66, 0.63–4.38) diabetes (1.15, 0.33–4.04) compared non‐exposure. revealed rates prematurity 2.57, 1.06–6.27) (2.97, 1.23–7.16) newborns, difficult interpret because short duration exposure. cases reported among 19 newborns near delivery. Conclusion This failed demonstrate significant association period malformations. More powerful prospective studies are required clarify reproductive safety profile aripiprazole. Copyright © 2015 John Wiley & Sons, Ltd.