May 18, 2020

The inclusion of pregnant and lactating women in clinical trials has been a topic of ethical discussion in research for decades. Because these women are currently excluded from studies, there is little data on which to base the safety of promising new drugs like remdesivir, which has recently demonstrated effectiveness against COVID-19 in human trials.

The lack of such data creates a dilemma that many health care providers are now facing: whether to advise lactating women to stop breastfeeding in order to administer a potentially life-saving drug or risk potential adverse effects of the drug on the child.

Dr. Alison Stuebe

Dr. Alison Stuebe

In a new commentary published today in Breastfeeding Medicine, Alison Stuebe, MD, MSc, professor of maternal and child health and distinguished scholar in infant and young child feeding at the Carolina Global Breastfeeding Institute at the UNC Gillings School of Global Public Health, concludes that suspending breastfeeding for mothers undergoing treatment with remdesivir could be detrimental. When mothers infected with COVID-19 stop breastfeeding, the child is denied critical nutrients in human milk, as well as antibodies that could protect the child from acquiring the virus.

Since pregnant and lactating women are not included in clinical trials – including the remdesivir trials – little is known about whether these drugs transfer into breast milk and reach the child’s circulation.

“Although many medications are present in human milk, levels are typically quite low, and the breastfeeding child consumes a fraction of a therapeutic dose,” Stuebe states in the commentary.

The dearth of research about drug effects in these women means health care providers will often advise new mothers to discontinue breastfeeding “just to be safe.” But requiring a mother with COVID-19 to stop breastfeeding in order to treat her with potential-life saving therapy may be the least safe option for her child.

“Excluding pregnant and lactating women from clinical trials forces clinicians and families to make critical decisions without evidence,” Stuebe says. “Rather than protecting women and children from research, we need to change the paradigm and protect them through research.”

Read the full commentary online.


Contact the UNC Gillings School of Global Public Health communications team at sphcomm@unc.edu.

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