Labeling

As with pregnancy, the newly proposed physician labeling rule [29] describes "Lactation" as a special population; lactating women are considered a subpopulation with altered physiology. When available, information from clinical lactation studies is often included in product labeling. Information from these studies may need to be cross-referenced to other labeling sections as well. Simply indicating that "drug is present in breast milk" or reporting the M/P without the contextual setting are not very helpful for patients or prescribers. Labeling should provide clinically meaningful information to assist health care providers and their patients make decisions about drug use in lactation.

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