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Reproductive Safety of Second-Generation Antipsychotics: Updated Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics
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Overview
What do data from a pregnancy registry demonstrate about the risk of major malformations among infants exposed to second-generation antipsychotics during the first trimester?
Read the whole article at psychiatrist.com here:
Reproductive Safety of Second-Generation Antipsychotics: Updated Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics
© Copyright 2021 Physicians Postgraduate Press, Inc.
Target Audience
Psychiatrists
Learning Objectives
Use current evidence to weigh risks of atypical antipsychotic prescription in pregnant women
CME Background
Articles are selected for credit designation based on an assessment of the educational needs of CME participants, with the purpose of providing readers with a curriculum of CME articles on a variety of topics throughout each volume. Activities are planned using a process that links identified needs with desired results.
CME Objective
After studying this article, you should be able to:
- Use current evidence to weigh risks of atypical antipsychotic prescription in pregnant women
Statement of Need and Purpose
Practitioners frequently prescribe psychotropic medications, including atypical antipsychotics, to pregnant women. Therefore, they need education on the latest data on the risks of these medications to fetal and infant health to help them balance possible risks with the overall health of pregnant patients and their infants.
Release, Expiration, and Review Dates
This educational activity was published in August 2021 and is eligible for AMA PRA Category 1 Credit™ through August 31, 2023. The latest review of this material was July 2021.
Disclosure of Off-Label Usage
The authors have determined that, to the best of their knowledge, no investigational information about pharmaceutical agents or device therapies that is outside US Food and Drug Administration–approved labeling has been presented in this activity.
Funding/Support
Current Sponsors of the NPRAA: Alkermes, Inc. (2016–Present); Johnson & Johnson/Jannsen Pharmaceuticals, Inc (2019–present); Otsuka America Pharmaceutical, Inc (2008–Present); Sunovion Pharmaceuticals, Inc (2011–Present), SAGE Therapeutics (2019–Present); Teva Pharmaceuticals (2018–Present); Aurobindo Pharma (2020–Present). Past Sponsors of the NPRAA: Forest/Actavis Pharmaceuticals (2016–2018); AstraZeneca Pharmaceuticals (2009–2014, declined to sponsor: 2014–Present); Ortho-McNeil-Janssen Pharmaceuticals, Inc (2009–2014, declined to sponsor: 2015–Present); Pfizer Inc (2009–2011, declined to sponsor: 2012–Present).
Role of the Sponsor
The sponsors of the NPRAA are pharmaceutical manufactures of medications of interest. In exchange for their support, sponsors receive safety reporting information and draft versions of manuscripts for comment at a minimum of 30 days before submission for comment.
Previous presentation
The current submission includes information published in Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Information encompassed in this submission was presented in a poster titled The National Pregnancy Registry for Psychiatric Medications: Effects of Fetal Exposure to Atypical Antipsychotics on Risk for Major Malformations at the American Society of Clinical Psychopharmacology annual meeting (virtual) May 29–30, 2020.
Acknowledgments
The authors thank and recognize Peter Gaccione, MA, for his contributions to data management and for his statistical programing for the National Pregnancy Registry. Mr Gaccione has nothing to disclose.
Faculty Affiliation
Adele C. Viguera, MD, MPH*
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston; Harvard Medical School, Boston, Massachusetts; and Cleveland Clinic, Cleveland Clinic Neurological Institute, Cleveland, Ohio
Marlene P. Freeman, MD
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston, and Harvard Medical School, Boston, Massachusetts
Lina Góez-Mogollón, MD, MSc
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston
Alexandra Z. Sosinsky, MS
Harvard T.H. Chan School of Public Health, Boston, Massachusetts
Sara A. McElheny, BA
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston
Taylor R. Church, BS
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston
Amanda V. Young, BA
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston
Phoebe S. Caplin, BA
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston
David Chitayat, MD
Mount Sinai Hospital, Prenatal Diagnosis and Medical Genetics Program, Toronto, Ontario, Canada
Sonia Hernández-Díaz, MPH, DrPH
Harvard T.H. Chan School of Public Health, Boston, Massachusetts
Lee S. Cohen, MD
Massachusetts General Hospital, Ammon-Pinizzotto Center for Women’s Mental Health, Boston, and Harvard Medical School, Boston, Massachusetts
*Corresponding author: Adele C. Viguera, MD, Cleveland Clinic, Cleveland Clinic Neurological Institute, 9500 Euclid Ave, Desk P 58, Cleveland, OH 44195 (VIGUERA@ccf.org).
Financial Disclosure
All individuals in a position to influence the content of this activity were asked to complete a statement regarding all relevant personal financial relationships between themselves or their spouse/partner and any commercial interest. The CME Institute has resolved any conflicts of interest that were identified. In the past year, Marlene P. Freeman, MD, Editor in Chief of The Journal of Clinical Psychiatry, has received research funding from JayMac and Sage; has been a member of the advisory boards for Otsuka, Alkermes, and Sunovion; has been a member of the Independent Data Safety and Monitoring Committee for Janssen; has been a member of the Steering Committee for Educational Activities for Medscape; and, as a Massachusetts General Hospital (MGH) employee, works with the MGH National Pregnancy Registry, which is sponsored by Teva, Alkermes, Otsuka, Actavis, and Sunovion, and works with the MGH Clinical Trials Network and Institute, which receives research funding from multiple pharmaceutical companies and the National Institute of Mental Health. No member of the CME Institute staff reported any relevant personal financial relationships.
Dr Viguera: Research Support: National Pregnancy Registry for Atypical Antipsychotics (NRPAA): Alkermes Biopharmaceuticals; Aurobindo Pharma; Janssen Pharmaceutica; Otsuka Pharmaceuticals; Sunovion Pharmaceuticals, Inc.; Teva Pharmaceuticals; SAGE Therapeutics, Inc. Other Research Support: None; Advisory/Consulting: Up-to-Date; Speaking/Honoraria: None; Royalty/patent, other income: None. Dr Freeman: NRPAA: Alkermes, Aurobindo, Janssen, Otsuka, Sunovion, Teva, SAGE Therapeutics. Other research support: JayMac Pharmaceuticals, SAGE Therapeutics. As an employee of MGH, Dr Freeman works with the MGH CTNI, which has had research funding from multiple pharmaceutical companies and National Institute of Mental Health. Advisory/Consulting: Advisory Boards: Eliem, Sage. Independent Data Safety and Monitoring Committee: Janssen (Johnson & Johnson), Novartis. Steering Committee for Educational Activities: Medscape. Educational activities: WebMD. Dr Hernández-Díaz: Consulting fees (e.g. advisory boards): Roche and UCB, and her institution received funding from Takeda for unrelated project; epidemiologist for the North American Antiepileptic Drugs pregnancy registry and advisor for the Antipsychotics Pregnancy Registry, which are funded by multiple companies. The Pharmacoepidemiology Program at the Harvard T.H. Chan School of Public Health is partially supported by training grants from Pfizer, UCB, Bayer, and Asisa. Dr Cohen: NRPAA: Alkermes, Aurobindo, Janssen, Otsuka, Sunovion, Teva, SAGEage Therapeutics. Other Research Support: Brain & Behavior Research Foundation; JayMac Pharmaceuticals; National Institute on Aging; National Institutes of Health; National Institute of Mental Health; SAGE Therapeutics; Takeda/Lundbeck. Advisory/Consulting: Alkermes (through MGH Clinical Trials Network Initiative); JDS Therapeutics; Praxis Precision Medicines (through MGH Clinical Trials Network Initiative). Mss Góez-Mogollón, Sosinsky, McElheny, Church, Young, Caplin, and Mr Chitayat have nothing to disclose.
Accreditation Statement
The CME Institute of Physicians Postgraduate Press, Inc., is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Credit Designation
The CME Institute of Physicians Postgraduate Press, Inc., designates this journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Note: The American Nurses Credentialing Center (ANCC) and the American Academy of Physician Assistants (AAPA) accept certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.
Available Credit
- 1.00 AMA PRA Category 1 Credit™
- 1.00 Participation