CC BY-NC-ND 4.0 · Am J Perinatol 2017; 34(08): 826-832
DOI: 10.1055/s-0037-1598070
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Improving Safe and Effective Use of Drugs in Pregnancy and Lactation: Workshop Summary

Laura E. Riley
1  Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
Alison G. Cahill
2  Department of Obstetrics and Gynecology, Washington University, St. Louis, Missouri
Richard Beigi
3  Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh Medical Center, Magee-Women's Hospital, Pittsburgh, Pennsylvania
Renate Savich
4  Division of Newborn Medicine and Neonatal Intensive Care Unit, University of Mississippi Medical Center, Jackson, Mississippi
George Saade
5  Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, Texas
› Author Affiliations
Further Information

Publication History

07 November 2016

27 December 2016

Publication Date:
31 January 2017 (online)


In February 2015, given high rates of use of medications by pregnant women and the relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine (SMFM), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics (AAP) convened a group of experts to review the “current” state of the clinical care and science regarding medication use during the perinatal period. The expert panel chose select medications to demonstrate what existing safety and efficacy data may be available for clinicians and patients when making decisions about use in pregnancy or lactation. Furthermore, these example medications also provided opportunities to highlight where data are lacking, thus forming a list of research gaps. Last, after reviewing the existing vaccine safety surveillance system as well as the legislative history surrounding the use of drugs for pediatric diseases, the expert panel made specific recommendations concerning policy efforts to stimulate more research and regulatory attention on drugs for pregnant and lactating women.


Workshop occurred at the Annual Meeting of the Society for Maternal-Fetal Medicine in February 2015 in San Diego, California.

Expert panelists:

Richard Beigi, MD, MSc—Magee-Women's Hospital of UPMC

David Burchfield, MD—COFN/AAP

Cheryl Broussard, PhD—CDC

Alison Cahill, MD—Washington University School of Medicine

Steve Caritis, MD—Magee-Women's Hospital of UPMC

Christina Chambers, MD—UC San Diego School of Medicine

Shannon M. Clark, MD—University of Texas Medical Branch

Michael Cohen-Wolkoweiz, MD—Duke University Medical Center

Maged Milad Costantine, MD—University of Texas Medical Branch

Jonathan Davis, MD—Floating Hospital for Children at Tufts Medical Center

Maisa Feghali, MD—University of Pittsburgh

Michael F. Greene, MD—Massachusetts General Hospital

Thomas W. Hale, RPh, PhD—Texas Tech University Health Sciences Center

Susan McCune, MD, MA Ed—FDA

Mirjana Nesin, MD—DMID/NIAID/NIH

Tonse Raju, MD—NIH

Sonja Rasmussen, MD—CDC

Adelaide Robb, MD—Children's National Medical Center

George Saade, MD—University of Texas Medical Branch

Melissa S. Tassinari, PhD, DABT—FDA

Barbara Wesley, MD, MPH—FDA

Amina White, PhD—NIH, Department of Bioethics

Chris Zahn, MD—ACOG

Anne Zajicek, MD, PharmD, FAAP—NICHD