Medications and Lactation: What PNPs Need to Know

Jennifer M. Marks, BS; Diane L. Spatz, PhD, RNC


J Pediatr Health Care. 2003;17(6) 

In This Article

Where to Seek Appropriate Information

Health care professionals overwhelmingly refer to the Physician's Desk Reference (PDR) to guide their medication recommendations for lactating mothers (2002). While the PDR is a fine reference if one is seeking information about the properties of a particular pharmaceutical (e.g., molecular weight, pH, protein-binding, etc.), it is considered a poor source of information about the potential effects of the medication on a lactating mother or her breastfeeding infant (Auerbach, 1999). What health care professionals fail to recognize is that the PDR is fundamentally a compilation of medication package inserts. In the interest of preventing a lawsuit against a pharmaceutical company, the standard recommendations for virtually all drugs is the inclusion of language forbidding their use by pregnant or lactating women (Auerbach, 1999). This caution is rarely based on medical research that has shown that the medication enters breast milk in clinically relevant amounts (Hale, 2002). Rather, manufacturers are required to state that a specific drug or compound is not recommended during lactation unless they have carried out extensive studies on lactating women and their breastfed infants (Lawrence, 1997). Thus, other sources are more applicable if one is interested in making evidence-based recommendations based on clinical studies and observations.

The American Academy of Pediatrics (AAP) Committee on Drugs issues an updated statement every 5 to 6 years in which information about the transfer of drugs into breast milk that is important to PNPs is reviewed (AAP, 1997). While this document is easily obtained, the list does have some problems. First, the AAP list is not exhaustive (Lawrence, 1997). Second, the list is compiled based on literature citations that may address single case reports or small studies of infants (AAP, 1997). Therefore, the generalizability to other mother-infant breastfeeding dyads is limited. Third, the list lacks a differentiation of whether the infant is a newborn who is premature or full-term, or is an older infant (Banta-Wright, 1997). Fourth, specific data on the drug properties and other factors (e.g., maternal factors, infant factors) used to determine the AAP's recommendations on medications are not mentioned. Fifth, the statement is only updated every 5 to 6 years, despite the plethora of new medications that reach the market eachyear. Finally, data on comparisons within drug classes (Banta-Wright, 1997) and recommendations about alternate medications available to practitioners and patients are not included in the AAP Committee on Drugs list.

In accordance with evidence-based research, the most comprehensive medication guide for breastfeeding mothers, endorsed by lactation experts across the country, is Medications and Mother's Milk (Hale, 2002). This manual of lactational pharmacology is a detailed reference book that compiles relevant published research literature and the AAP recommendations (Box). The text is updated bi-annually and any changes or additions that occur between published editions are updated on the book's affiliated website ( It is considered an essential resource for making case-by-case decisions about drug therapy based on the potential risks and benefits to both the lactating mother and her breastfeeding infant (Auerbach, 1999). Furthermore, Hale reports only information that is documented in relevant published literature. Thus, Hale's Medications and Mother's Milk adequately addresses the pertinent issues affecting medications and lactation through research-based data, allowing health care providers to obtain specific evidence-based research from one comprehensive source.

Many communities have drug information centers with hotlines that disseminate information on issues related to lactation and drug therapy. The goal of the drug information centers is to present accurate and unbiased information on patient-related problems with drug therapy. A comprehensive list of drug information centers is available in an annual pharmacists' reference titled The Drug Topics Red Book (2002). Some drug information sources available as resources to health care professionals are listed in the Table .


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