Authors

  1. Spatz, Diane L. PhD, RN-BC, FAAN

Article Content

I have served as the only PhD-prepared nurse as part of a planning committee for a conference held at the National Academies of Sciences, Engineering, and Medicine (NASEM, 2022) in June 2022. The meeting was a follow-up to the Congressional Taskforce on Research Specific to Pregnant Women and Lactating Women (PRGLAC) and had a goal of developing actionable changes to ensure inclusion of lactating people and pregnant people in research and best practices for doing so. In addition to health care professionals, federal agencies, community advocacy groups, and pharmaceutical company representatives were active and engaged in the 2-day meeting. This is notable because we currently have no medication approved by the Food and Drug Administration (FDA) to treat low milk supply in the United States. Since the start of PRGLAC, I have been advocating for pharmaceutical companies to consider bringing a product to market to treat low milk supply.

 

In 2020, about 3.6 million people gave birth in the United States with over 80% initiating breastfeeding, thus representing almost 3 million people. Despite the increase in breastfeeding initiation rates, our exclusive human milk rates at 6 months are suboptimal (Centers for Disease Control and Prevention, 2021). One of the major concerns of lactating people is perceived insufficient milk supply or actual insufficient milk supply (Wood et al., 2021). In a recent study about perceived insufficient milk supply, parents reported concerns about infant crying and fussing, feeding frequently, and difficulty with latching (Wood et al., 2021). All are common concerns of new parents and may indicate milk supply could be compromised. The first hour, first 3 to 5 days, and first 2 weeks are all critical for activating prolactin receptor sites in the breast and for coming to volume. If the lactating person does not come to volume during the critical window, milk supply could be suboptimal for the rest of their lactation journey with no FDA-approved treatment option.

 

There is a medication that is used in other countries globally (Domperidone) that significantly increases milk supply with no side effects for infants (Grzeskowiak, 2014). The FDA issued a warning against this product because of case reports of fatal cardiac arrhythmias when the medication was administered intravenously to cancer patients (Grzeskowiak, 2014). For treatment of milk supply, the medication is given orally at a much lower dosage to healthy lactating people (Grzeskowiak, 2014). With the current state of formula shortages in the United States, it seems evident that we need an FDA-approved medication to treat low milk supply.

 

There is a registered clinical trial developed by Ferring pharmaceutical company to evaluate a medication to treat low milk supply but only in mothers of preterm infants (ClinicalTrials.gov). However, even with this trial, it would be years until a product came to market in the United States leaving women who experience low milk supply with no effective medication treatment options. At the NASEM meeting, I urged representatives of the FDA to consider prioritizing the treatment of milk supply and consider looking into what strategies could be developed to help more women sooner based on options available globally. Nurses can be effective advocates for women's health when they have the opportunity to serve on national committees.

 

References

 

Centers for Disease Control and Prevention. (2021). Breastfeeding report card, 2020. Retrieved June 17, 2022, from Breastfeeding Report Card | Breastfeeding | CDC [Context Link]

 

ClinicalTrials.gov. Merotocin in mothers with inadequate milk production and infants delivered prematurely. Retrieved June 17, 2022, from Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely - Full Text View - ClinicalTrials.gov

 

Grzeskowiak L. (2014). Use of domperidone to increase breast milk supply: Are women really dying to breastfeed? Journal of Human Lactation, 30(4), 498-499. https://doi.org/10.1177/0890334414552525[Context Link]

 

National Academies of Sciences, Engineering, and Medicine. (2022). Inclusions of pregnant and lactating persons in clinical trials-A workshop. Retrieved June 17, 2022, from Inclusion of Pregnant and Lactating Persons in Clinical Trials A Workshop | National Academies [Context Link]

 

Wood N. K., Odom-Maryon T., Smart D. A. (2021). Factors associated with perceived insufficient milk in the first three months of breastfeeding. MCN. The American Journal of Maternal Child Nursing, 46(4), 223-229. https://doi.org/10.1097/NMC.0000000000000723[Context Link]