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

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Public health initiatives, including the Health Resources and Services Administration Women's Preventive Services Guidelines, have brought renewed focus on the health benefits of breastfeeding and the need for comprehensive efforts to increase the rate of breastfeeding in the US.1 In the US, ∼10% of reproductive‐age women become pregnant each year, leading to more than 6 million pregnancies and more than 4 million deliveries annually.2 Women take an average of three medications during their entire pregnancy, and four medications during lactation.3 When a lactating woman takes a drug and the drug is present in her milk, the infant is exposed to both the benefits afforded by milk as well as the potential risks from a drug that is not intended to treat a condition in the infant.
Despite significant efforts to improve drug labeling for medication use during lactation, there remains a paucity of human data in these understudied populations.4 Lactating women and their healthcare providers often make decisions about drug treatment and about continuation of breastfeeding during therapy in the absence of quality human data in product labeling. In order for that decision to be evidence‐based, needed information would include at a minimum the amount of drug in human milk, the effect of the drug on milk production, and an understanding of the risks of the drug on the breastfed infant based on expected levels of exposure.
The US Food and Drug Administration (FDA) has recognized that data from clinical lactation studies, along with all other available data (e.g., drug physicochemical characteristics, mechanisms of medication entry into breast milk, and important infant factors) could be leveraged to inform the safety of a drug when used during lactation.5 Thus, in November 2007, the Pediatric Advisory Committee (PAC) meeting discussed issues related to the 2005 US FDA draft Guidance for Industry: Clinical Lactation Study – Study Design, Data Analysis, and Recommendations for Labeling. The PAC members agreed that information from clinical lactation studies would be useful to practitioners and breastfeeding women when making risk/benefit decisions regarding medication use during breastfeeding. The Committee also discussed 1) different types of study designs to collect specific lactation data and drug characteristics that might fit with each type of study; 2) the challenging issues of when and how to conduct clinical lactation studies; and 3) how to assess the influence of drugs and therapeutic biological products on lactation.
In this report, we provide a summary of the workshop entitled “Evaluation of the Safety of Drugs and Biological Products Used During Lactation” held on April 27–28, 2016, in Silver Spring, MD. The workshop was sponsored by the Division of Pediatric and Maternal Health, Office of Drug Evaluation IV at the FDA.
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