Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations

The availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, the FDA published a revised draft guidance, "Clinical Lactation Studies: Considerations for Study Design," to provide pharmaceutical companies and investigators with information about how and when to conduct lactation studies. Clinical pharmacology information derived from lactation studies is important in determining the presence of medications in breast milk and counseling lactating individuals regarding the potential of medication exposure in the breast milk and its attendant risks to the breastfed infant. Examples of Pregnancy and Lactation Labeling Rule labeling changes that resulted from dedicated clinical lactation studies for certain neuropsychiatric medications are described in this publication. These medications are discussed because neuropsychiatric conditions commonly affect women of reproductive potential, including lactating individuals. As the FDA guidance and these studies illustrate, bioanalytical method validation, study design, and data analysis considerations are essential for obtaining quality lactation data. Well-designed clinical lactation studies play an important role in informing product labeling that ultimately is useful to health care providers in making prescribing decisions with lactating individuals.