title: Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.
abstract: OBJECTIVE
  Second-generation antipsychotics are used to treat a spectrum of psychiatric illnesses in reproductive-age women. The National Pregnancy Registry for Atypical Antipsychotics was established to determine the risk of major malformations among infants exposed to second-generation antipsychotics during pregnancy relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity.
  
  
  METHODS
  Women were prospectively followed during pregnancy and the postpartum period; obstetric, labor, delivery, and pediatric medical records were obtained. Eligible enrollees were pregnant women ages 18-45. The Registry is based at the Center for Women's Mental Health at Massachusetts General Hospital. Women were recruited through provider referral, self-referral, and the Center's web site.
  
  
  RESULTS
  As of December 2014, 487 women were enrolled: 353 who used second-generation antipsychotics and 134 comparison women. Medical records were obtained for 82% of participants. A total of 303 women had completed the study and were eligible for inclusion in the analysis. Of 214 live births with first-trimester exposure to second-generation antipsychotics, three major malformations were confirmed. In the control group (N=89), one major malformation was confirmed. The absolute risk of major malformations was 1.4% for exposed infants and 1.1% for unexposed infants. The odds ratio for major malformations comparing exposed infants with unexposed infants was 1.25 (95% CI=0.13-12.19).
  
  
  CONCLUSIONS
  The results suggest that it would be unlikely for second-generation antipsychotics to raise the risk of major malformations more than 10-fold beyond that observed in the general population or among control groups using other psychotropic medications. If the estimate stabilizes around the null with ongoing data collection, findings may be reassuring for both clinicians and women trying to make risk-benefit treatment decisions about using atypical antipsychotics during pregnancy. These findings are timely given the renewed focus of regulatory agencies on reproductive safety.
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Cohen
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Adele C
authors.initials: AC
authors.lastname: Viguera
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: McInerney
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Marlene P
authors.initials: MP
authors.lastname: Freeman
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Alexandra Z
authors.initials: AZ
authors.lastname: Sosinsky
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Danna
authors.initials: D
authors.lastname: Moustafa
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Samantha P
authors.initials: SP
authors.lastname: Marfurt
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Molly A
authors.initials: MA
authors.lastname: Kwiatkowski
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Shannon K
authors.initials: SK
authors.lastname: Murphy
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Adriann M
authors.initials: AM
authors.lastname: Farrell
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: David
authors.initials: D
authors.lastname: Chitayat
authors.affiliation: From the Center for Women's Mental Health, Massachusetts General Hospital, Boston; the Department of Epidemiology, Boston University School of Public Health, Boston; the Department of Epidemiology, Harvard School of Public Health, Boston; the Cleveland Clinic Neurological Institute, Cleveland; UC San Diego School of Medicine, La Jolla, Calif.; the Department of Psychology, Temple University, Philadelphia; and the Departments of Pediatrics, Molecular Genetics, Obstetrics and Gynecology, and Laboratory Medicine and Pathobiology, University of Toronto, Toronto.
authors.forename: Sonia
authors.initials: S
authors.lastname: Hernández-Díaz
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000145:classification; D005260:Female; D006801:Humans; D008404:Massachusetts / Q000453:epidemiology; D001523:Mental Disorders / Q000188:drug therapy / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D011256:Pregnancy Outcome; D011264:Pregnancy Trimesters / Q000187:drug effects; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology / Q000209:etiology; D012042:Registries / Q000706:statistics & numerical data
chemical_list: D014150:Antipsychotic Agents