Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

J Wang¹, T Johnson², L Sahin², M S Tassinari², P O Anderson³, T E Baker⁴, C Bucci-Rechtweg⁵, G J Burckart⁶, C D Chambers⁷, T W Hale⁴, D Johnson-Lyles², R M Nelson⁸, C Nguyen⁹, D Pica-Branco², Z Ren¹⁰, H Sachs², J Sauberan¹¹, A Zajicek¹⁰, S Ito¹², L P Yao²

Affiliations

¹ Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
³ Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, California, USA.
⁴ Infantrisk Center, Texas Tech University Health Sciences Center Amarillo, Amarillo, Texas, USA.
⁵ Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey, USA.
⁶ Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁷ School of Medicine, University of California San Diego, La Jolla, California, USA.
⁸ Office of Pediatric Therapeutics, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁹ Division of Bone, Reproductive, and Urologic Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁰ Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Health, Bethesda, Maryland, USA.
¹¹ Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.
¹² Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, Hospital For Sick Children, Toronto, Ontario, Canada.

PMID: 28510297
PMCID: PMC5591026
DOI: 10.1002/cpt.676

Review

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

J Wang et al. Clin Pharmacol Ther. 2017 Jun.

. 2017 Jun;101(6):736-744.

doi: 10.1002/cpt.676.

Authors

Affiliations

¹ Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
³ Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, California, USA.
⁴ Infantrisk Center, Texas Tech University Health Sciences Center Amarillo, Amarillo, Texas, USA.
⁵ Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey, USA.
⁶ Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁷ School of Medicine, University of California San Diego, La Jolla, California, USA.
⁸ Office of Pediatric Therapeutics, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁹ Division of Bone, Reproductive, and Urologic Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁰ Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Health, Bethesda, Maryland, USA.
¹¹ Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.
¹² Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, Hospital For Sick Children, Toronto, Ontario, Canada.

PMID: 28510297
PMCID: PMC5591026
DOI: 10.1002/cpt.676

Abstract

This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.

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Conflict of interest statement

CONFLICT OF INTEREST

The authors have no conflicts of interest relevant to this article to disclose.

References

1. Bronaugh RL, Stewart RF, Congdon ER, Giles AL., Jr Methods for in vitro percutaneous absorption studies I Comparison with in vivo results. Toxicol Appl Pharmacol. 1982;62:474–480. - PubMed
1. Sachs HC. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013;132:e796–809. - PubMed
1. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernandez-Diaz S. Medication use during pregnancy, with particular focus on prescription drugs: 1976–2008. Am J Obstet Gynecol. 2011;205:51e1–8. - PMC - PubMed
1. Mazer-Amirshahi M, Samiee-Zafarghandy S, Gray G, van den Anker JN. Trends in pregnancy labeling and data quality for US-approved pharmaceuticals. Am J Obstet Gynecol. 2014;211:690e1–11. - PubMed
1. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Child Adolesc Psychiatr Clin N Am. 2015;24:1–20. - PubMed

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Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

Affiliations

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical