Significant Updates in Hale's 2025-2026 Edition: Enhancing Drug Safety for Breastfeeding Mothers

It seems the release of new drugs continues to increase each year, although the data published for breastfeeding mothers are still minimal. Each year there are so many new FDA-approved medications that it is difficult to choose which to add. As usual, we chose those that a breastfeeding mother would most likely use.

This new 2024-2025 edition has many significant updates including:

More than 66 new drugs, even though we don’t know if and how much many transfer into human milk. We evaluated the relative risk of each drug and provided a lactation risk category for each new drug.

Our laboratories have been publishing many new breastfeeding drug studies. We added these new studies to the book, even if the data are unpublished.

New data include drugs for weight loss (like Ozempic), heart failure (like Entresto and lisinopril), anxiety and postpartum depression (like busprione and zuranolone), nausea (like ondansetron), and COVID-19 (like Paxlovid).

LRC’s (Lactation Risk Categories) for HIV medications have been revised considering new guidelines which now support breastfeeding mothers with undetectable viral loads who are on antiretroviral treatment.

Each year more than 3 million mothers visit the InfantRisk website seeking information about drugs and pregnancy and breastfeeding. So many breastfeeding mothers have volunteered for our drug studies that we simply can’t collect information from all of them. But from these wonderful volunteers come the many new studies from our laboratories.

Thanks to all the lactation consultants and healthcare professionals that have helped us recruit patients for our studies. We will continue to pour out new studies that help moms continue breastfeeding their wonderful infants.

Thomas W. Hale & Kaytlin Krutsch