Mass General Hospital

Harvard Medical School

National Pregnancy Registry for Atypical Antipsychotics

The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken by women during pregnancy to treat a wide range of mood, anxiety, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

TO PARTICIPATE CALL TOLL-FREE: 1-866-961-2388

All pregnant women ages 18-45 are eligible to enroll in the registry. If you are interested in participating in the National Pregnancy Registry, please call the toll-free number above or fill out this Patient Interest Form to be contacted by a member of our research team. All information is kept strictly confidential.

More Information and Enrollment

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For Clinicians v4

About the Registry

Who is eligible for the Registry?

All pregnant women ages 18-45 are eligible to enroll in the registry. We are currently seeking both controls and those being treated with one or more of the following atypical antipsychotics:

  • Abilify (aripiprazole)
  • Aristada (aripiprazole lauroxil)
  • Clozaril (clozapine)
  • Fanapt (iloperidone)
  • Geodon (ziprasidone)
  • Invega (paliperidone)
  • Latuda (lurasidone)
  • Rexulti (brexpiprazole)
  • Risperdal (risperidone)
  • Saphris (asenapine)
  • Seroquel (quetiapine)
  • Zyprexa (olanzapine)

National Pregnancy Registry Poster

Click to download the Pregnancy Registry Poster

Resources on Atypical Antipsychotics

Articles

Cohen LS. Drugs, Pregnancy and Lactation: Atypical Antipychotics During Pregnancy. ObGyn News, April 2008

Cohen LS, Viguera AC, McInerny KA, Freeman MP, et al. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Am J Psychiatry 2015.

Coppola D, Russo LJ, Kwarta RF, et al: Evaluating the postmarketing experience of risperidone use during pregnancy: Pregnancy and neonatal outcomes. Drug Safety 30(3):247-264, 2007.

Ernst CL, Goldberg JF. The reproductive safety profile of mood stabilizers, atypical antipsychotics, and broad-spectrum psychotropics. J Clin Psychiatry 2002;63 Suppl 4:42-55.

Gentile, S. Clinical Utilization of Atypical Antipsychotics in Pregnancy and Lactation. Annals of Psychiatry, 2004. 38:1265-1271.

Goldstein DJ, Corbin LA, Fung MC. Olanzapine-exposed pregnancies and lactation: Early experience. J Clin Psychopharmacol 2000; 20(4).

Kulkarni J, McCauley-Elsom K, Marston N, Gilbert H, Gurvich C, de Castella A, Fitzgerald P. Preliminary findings from the National Register of Antipsychotic Medication in Pregnancy. Australian and New Zealand Journal of Psychiatry 2008; 42:38-44.

McKenna K, Koren G, Tetelbaum M, et al: Pregnancy outcome of women using atypical antipsychotic drugs: A prospective comparative study. J Clin Psychiatry 66(4):444-449, 2005.

Newham JJ, Thomas SH, MacRitchie K, McElhatton PR. Birth weights of infants after maternal exposure to typical and atypical antipsychotics: Prospective comparison study. The British Journal of Psychiatry 2008. 192:333-337.

Newport DJ, Calamaras MR, DeVane CL, Donovan J, Beach AJ, Winn S, Knight BT, Gibson BB, Viguera AC, Owens MJ, Nemeroff CB, Stowe ZN. Atypical antipsychotic administration during late pregnancy: placental passage and obstetrical outcomes. Am J Psychiatry. 2007 Aug;164(8):1214-20.

Peindl KS, Masand P, Mannelli P, Narasimhan M, Patkar A. Polypharmacy in pregnant women with major pyschiatric illness: A pilot study. Journal of Psychiatric Practice 2007; 13(6):385-92.

Reis M, Kallen B. Maternal use of antipsychotics in early pregnancy and delivery outcome. Journal of Clinical Psychology 2008. 28(3):279-288.

Wichman CL. Atypical antipsychotic use in pregnancy: A retrospective review. Arch Women’s Ment Health 2009 Jan 10 (Epub ahead of print).

Yaeger D, Smith HG, Altshulter L. Atypical antipsychotics in the treatment of schizophrenia during pregnancy and the postpartum. Am J Psychiatry 2006. 163(12): 2064-2070.

Click to view a collection of peer-reviewed articles on atypical antipsychotics.

Case Studies

Abilify (aripiprazole)

Mendhekar DN, Sharma JB, Srilakshmi P. Use of aripiprazole during late pregnancy in a woman with psychotic illness. The Annals of Pharmacotherapy 2006; 40(3):575.

Mendhekar DN, Sunder KR, Andrade C. Aripiprazole use in a pregnant schizoaffective woman. Bipolar Disord 2006; 8(3):299-300.

Clozaril (clozapine)

Barnas C, Bergant A, Hummer M, Saria A, Fleischhacker W. Clozapine concentrations in maternal and fetal plasma, amniotic fluid, and breast milk. Am J Psychiatry 1994; 151:6.

Dickson R, Hogg L. Pregnancy of a patient treated with clozapine. Psychiatr Serv 1998; 49:1081-1083.

Duran A, Ugur MM, Turan S, Emul M. Clozapine use in two women with schizophrenia during pregnancy. J Psychopharmacol. 2008 Jan; 22(1):111-3

Mendhekar DN. Possible delayed speech acquisition with clozapine therapy during pregnancy and lactation. J Neuropsychiatry Clin Neurosci 2007; 19(2):196-7.

Nguyen HN, Lalonde P. [Clozapine and pregnancy]. Encephale 2003. 29(2):119-124.

Stoner SC, Sommi RW, Marken PA, Anya I, Vaughn J. Clozapine use in two full-term pregnancies. J Clin Psychiatry 1997. 58(8):364-365

Tenyi T, Trixler M, Vereczkey G, Dorka A. [Use of clozapine during pregnancy]. Orv Hetil 1994. 135(36):1967-9.

Waldman MD, Safferman AZ. Pregnancy and clozapine. Am J Psychiatry 1993. 150(1):168-169

Yogev Y, Ben-Haroush A, Kaplan B. Maternal clozapine treatment and decreased fetal heart rate variability. Int J Gynaecol Obstet 2002. 79:259-260.

Risperdal (risperidone)

Dabbert D, Heinze M. Follow-up of a pregnancy with risperidone microspheres. Pharmacopsychiatry 2006; 39:235.

Ratnayake T, Libretto S. No complications with risperidone treatment before and throughout pregnancy and during the nursing period. J Clin Psychiatry 2002. 63(1):76-77

Seroquel (quetiapine)

Cabuk D, Sayin A, Biri A. Quetiapine use for the treatment of manic episode during pregnancy. Arch Women’s Ment Health 2007; 10(5):235-6.

Klier CM, Mossaheb N, Saria A, Schloegelhofer M, Zernig G. Pharmacokinetics and elimination of quetiapine, venlafaxine, and trazodone during pregnancy and postpartum: Case report. Journal of Clinical Psychiatry 2007; 27(6):720-722.

Taylor TM, O’Toole MS, Ohlsen RI, Walters J, Pilowsky LS. Safety of quetiapine during pregnancy. Am J Psychiatry 2003. 160(3): 588-589.

Tenyi T, Trixler M, Keresztes Z. Quetiapine and pregnancy. Am J Psychiatry 2002. 159(4):674

Zyprexa (olanzapine)

Arora M, Praharaj SK. Meningocele and akyloblepharon following in utero exposure to olanzapine. Eur Psychiatry 2006 Jul; 21(5):345-6.

Kirchheiner J, Berghofer A, Bolk-Weischedel D. Healthy outcome under olanzapine treatment in a pregnant woman. Pharmacopsychiatry 2000 Mar; 33(2):78-80.

Malek-Ahmahdi P. Olanzapine in pregnancy. The Annals of Pharmacotherapy 2001; 35(10):1294-1295.

Mendhekar DN, War L, Sharma JB, Jiloha RC. Olanzapine and pregnancy. Pharmacopsychiatry 2002; 35(3):122-123

Nagy A, Tenyi T, Lenard K, Herold R, Wilhelm F, Trixler M. [Olanzapine and pregnancy]. Orv Hetil 2001; 142(3):137-8.

Neumann NU, Frasch K. [Olanzapine and pregnancy. 2 case reports]. Nervenarzt 2001; 72(11):876-8.

Spyropoulou AC, Zervas IM, Soldatos CR. Hip dysplasia following a case of olanzapine exposed pregnancy: A questionable association. Arch Womens Ment Health 2006. 9(4): 219-22.

Yeshayahu Y. The use of olanzapine in pregnancy and congenital cardiac and musculoskeletal abnormalities. Am J Psychiatry 164(11): 1759-1760.

Click to read case studies reviewing Abilify, Clozaril, Risperdal, Seroquel and Zyprexa.

Click to view blog posts written by members of the CWMH for the everyday reader.


Current Sponsors: Alkermes, Inc. (2016-Present); Otsuka America Pharmaceutical, Inc. (2008-Present); Forest/Actavis (2016-Present), Sunovion Pharmaceuticals, Inc. (2011-Present) 

Past Sponsors: AstraZeneca Pharmaceuticals (2009-2014, declined to sponsor: 2014-Present); Ortho-McNeil-Janssen Pharmaceuticals, Inc (2009-2015, declined to sponsor: 2015-Present); Pfizer, Inc. (2009-2011, declined to sponsor: 2012-Present) 

Declined to sponsor: Eli Lilly and Company; Novartis Pharmaceuticals; Teva Pharmaceuticals; Vanda Pharmaceuticals Inc. 

Funding Information: Manufacturers of atypical antipsychotics have been approached regarding funding of the National Pregnancy Registry for Atypical Antipsychotics. Regardless of which entities have supported this initiative, all medications in this class are studied. For more information on how to sponsor the Registry, please see the contact information below.

Call Toll-Free: 1-866-961-2388
Email: registry@womensmentalhealth.org
Website: www.womensmentalhealth.org/pregnancyregistry

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