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Book Review: Medications and Mothers' Milk, 12th Edition

by Thomas W. Hale, PhD
Hale Publishing, 2006
Reviewed by Nancy Clendenon
Richmond VA USA
From: LEAVEN, Vol. 43 No. 1, January-February-March 2007, p. 13

As a La Leche League Leader, there are many books that I find helpful, but there are only a few that I consider absolutely essential. Dr. Thomas Hale's 12th edition of Medications and Mothers' Milk is one of the indispensable tools that should be read by all LLL Leaders.

Hale, a clinical pharmacologist and professor at Texas Tech University School of Medicine (USA), is recognized as one of the foremost authorities on the use of medications by breastfeeding mothers. Medications and Mothers' Milk brings together a vast amount of up-to-date information about more than 800 medications, herbs, vaccines, and other substances that may pass into human milk, including more than 70 new drugs not covered in the previous edition published in 2004. (Hale's Web page on Texas Tech University's Web site contains a breastfeeding and medications forum where one can post questions not answered in the book. See

Hale's book contains entries on individual medications, both prescription and over-the-counter. He details information about uses, forms that are available, trade and generic names, and lactation risk. As a Leader, I will read aloud this information to give a mother a general sense of what is known about the medication, and then I will offer to copy and send her the complete entry to take with her to an appointment with her health care provider.

Because of legal liability, most drug manufacturers recommend in their package inserts that their drug not be used by breastfeeding mothers, but these recommendations often do not take into account what is known about the physicochemical (physical and chemical) properties that affect how the drug transfers into human milk and to the infant. Hale's book fills a much-needed gap by providing that information. Hale specifically states: "Most drugs are quite safe in breastfeeding mothers" and that "the risk of not breastfeeding and instead using infant formula is much higher for the infant."

Dr. Hale assigns a Lactation Risk Category to each drug, similar to the better-known Pregnancy Risk Categories that are assigned by pharmaceutical manufacturers. His categories range from a designation of L1—suggesting a drug is "safest" based upon controlled studies in breastfeeding women or because it has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant—to L5, indicating a drug should not be used by breastfeeding mothers because "there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant."

Hale notes that special consideration should be given to newborns and premature infants. Some medications that might be more of concern in a younger infant could be much less worrisome in an older nursling, who will be better able to metabolize substances and because milk would be a lesser percentage of baby's nutrition.

Hale's work contains a great deal of new or expanded, well-organized material. In addition to revising drug entries and adding information about drugs that are newly released or studied since the last edition of his book, some notable new features are a comprehensive list of over-the-counter cold and flu remedies and topical corticosteroids, with brief notes about any potential concerns for the nursing baby or nursing mother. He also added an appendix on using radiopharmaceutical products for both diagnostic procedures and disease treatment in breastfeeding mothers, with current recommendations on if or how long nursing must be withheld. Hale also includes an appendix of information on cancer chemotherapeutic agents and a list of herbal drugs that he does not consider safe during lactation.

Behind all of Dr. Hale's research is a profound respect for the immunologic and nutritional benefits of breastfeeding, consistent with the LLL concept that human milk is the superior infant food. He notes that 90-99 percent of women who breastfeed will receive a medication during the first week postpartum, and many will be prescribed a medication or will select a medication or herb on their own at some point during their breastfeeding experience. In Dr. Hale's own words, "The risks of formula feeding are significant and should not be trivialized."

His research and life's work have done a great deal to promote and protect breastfeeding as the norm for infant feeding. Having been in situations myself as a nursing mother where I have been given incomplete or erroneous information from a health care provider about needing to stop breastfeeding so that I could treat an illness, I have a strident wish that every pediatrician's office and family practice office have a copy of this extremely affordable reference work and that all professionals in these practices would be familiar with the range of information it contains.

Medications and Mothers' Milk is an affordable, concise resource that, as a Leader, I find myself reaching for often during helping calls, and as a breastfeeding mother using it for my own health care needs.

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