title: Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study.
abstract: OBJECTIVE
  The main purpose of this study was to evaluate the risk of major malformations after aripiprazole exposure during the embryonic period. The secondary purposes were to assess the risk of miscarriage, prematurity, fetal growth retardation and maternal complications and to describe possible neonatal adverse effects.
  
  
  METHODS
  We conducted a cohort study using data prospectively collected by the French Pharmacovigilance Centres participating to the Terappel program and the Centre de Référence sur les Agents Tératogènes between 2004 and 2011. The exposed group consisted of pregnant women exposed to aripiprazole during embryogenesis, and the unexposed group consisted of pregnant women without exposure or exposed to non-teratogenic agents. Two unexposed patients, matched for age and gestational age at call, were randomly selected for each exposed patient.
  
  
  RESULTS
  Eighty-six patients were included in the exposed group and 172 in the unexposed group. Exposure to aripiprazole was not significantly associated with an increased rate of major malformations (OR 2.30, 95%CI 0.32-16.7) or miscarriage (1.66, 0.63-4.38) or gestational diabetes (1.15, 0.33-4.04) compared to non-exposure. The study revealed significantly increased rates of prematurity (OR 2.57, 95%CI 1.06-6.27) and fetal growth retardation (2.97, 1.23-7.16) in exposed newborns, difficult to interpret because of the short duration of maternal exposure. Two cases of neonatal complications were reported among the 19 newborns exposed to aripiprazole near delivery.
  
  
  CONCLUSIONS
  This study failed to demonstrate a significant association between aripiprazole exposure during the embryonic period and major malformations. More powerful prospective studies are required to clarify the reproductive safety profile of aripiprazole.
authors: Centre Régional de Pharmacovigilance, Centre Hospitalo-Universitaire, Saint-Etienne, France.
authors: Florelle
authors: F
authors: Bellet
authors: Marie-Noëlle
authors: MN
authors: Beyens
authors: Nathalie
authors: N
authors: Bernard
authors: Delphine
authors: D
authors: Beghin
authors: Elisabeth
authors: E
authors: Elefant
authors: Thierry
authors: T
authors: Vial
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects*; D000068180:Aripiprazole / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D005317:Fetal Growth Retardation / Q000139:chemically induced; D006801:Humans; D018811:Maternal Exposure / Q000009:adverse effects*; D008875:Middle Aged; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced*; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000139:chemically induced; D011446:Prospective Studies
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole
keywords: aripiprazole; cohort study; embryogenesis; malformation; pharmacoepidemiology; pregnancy