Evaluation of the Safety of Drugs and Biological Products Used During Lactation

April 27-28, 2016

Marsha Walker, RN, IBCLC


The purpose of this 2-day workshop was to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop reviewed current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop discussed and considered novel approaches to improve the quality and quantity of data to inform about potential risks of medication use during lactation and raised awareness and engaged stakeholders about communication of safety information related to maternal use of medications during lactation.   Day 1 of the workshop focused on review and discussion of current approaches for the collection of data, a review and discussion of gaps in our present knowledge and a discussion of strategies to communicate safety information related to maternal use of medications during lactation.  Day 2 of the workshop was a discussion of the Day 1 information with a focus on consideration of novel approaches to improve the quality and quantity of data available to assess the safety of medications used during lactation. All of the slides from each presentation as well as the agenda and a description of all of the panelists can be found at http://www.fda.gov/Drugs/NewsEvents/ucm486761.htm.


Panelists included Philip Anderson who founded and writes LactMed, Theresa Baker from Tom Hale’s Infant Risk Center, a number of pharmacologists, people from the National Library of Medicine, several from the FDA, some from pharmaceutical companies, and some from companies that run the clinical studies of new medications. Ruth Lawrence started off the meeting with a review of the importance of breastfeeding to both mothers and infants. Many of the talks included how these studies are conducted but their methodology often does not look at the adverse effects of the drug on the mechanics of breastfeeding by the infant. The FDA recently changed the requirements to the content and format for prescription drug labeling to better assist prescribing clinicians in assessing the risk versus the benefit of the drug and to better counsel nursing mothers who need to take the medication. This new labeling requirement is called the Pregnancy and Lactation Labeling Rule (PLLR) which can be found at https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241.pdf. The PLLR has removed the pregnancy letter categories (A, B, C, D, and X). The revised labeling will include more information on whether medication gets into breast milk, and—based on how much of it is present—how it can possibly affect the infant. Companies will have to remove the pregnancy letter categories from the labeling for all prescription drugs and biological products and, for many of them, revise the labeling with updated information. This is a large undertaking that will take several years. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm Much of the discussion revolved around how to secure information about drug levels in breastmilk and the effect on the nursing infant.


My talk and request to the FDA and the pharmaceutical representatives included a plea to study not only drug transfer into breastmilk but also a drug’s effect on sucking, hypotonia, sedation, etc—i.e. what we could expect to see clinically in a breastfed infant whose mother had taken the drug. I asked for the definition of “adverse outcome” or “side effects” to include the effects on the breastfeeding itself, not just how much of the drug the infant was exposed to. I also asked that the effects of the drug on milk production and milk components be studied. I reminded the group that mothers are often taking other supplements that they do not consider as medication such as herbals for improving milk production. I thought that this should also be factored in when doing their drug studies.These are what would be of interest to lactation consultants.

There will be a paper written by the FDA summarizing the meeting and we will have the opportunity to add comments to it. This will hopefully make sure that our comments are heard.