August 27, 2013
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FDA proposes new guidelines for breast-feeding, drug use

Some mothers are inappropriately advised to discontinue breast-feeding or take certain medications, according to recent study findings.

“Lactating women can be exposed to medications or other therapeutics either on a limited or long-term basis, depending on the need to treat acute or chronic conditions,” according to background information for the report published in Pediatrics. “Many women are advised to discontinue nursing or avoid taking necessary medication because of concerns about possible adverse effects in their infants.”

According to researchers, many factors must be considered when decided whether the benefit of breast-feeding outweighs the risk of exposure to therapeutic agents via human milk, including: “the need for the drug by the mother, the potential effects of the drug on milk production, the amount of drug excreted into human milk, the extent of oral absorption by the breast-feeding infant, and potential adverse effects on the breast-feeding infant.”

The FDA proposed new labeling changes in 2008 that will affect the pregnancy and lactation sections. The new section, “Lactation,” will include risk summaries, clinical considerations and data. The risk summary will include what is known about the drug excretion into the breast milk and potential effects on the infant. Clinical considerations will include methods to minimize exposure and monitoring for any expected adverse effects. The data section will include existing data that gives evidence for the other sections.

One database, LactMed, includes information on drug levels in human milk and infant serum. Possible adverse effects on the infant, lactation and alternative drugs are all listed in the database.

“Although most drugs and therapeutic agents do not pose a risk to the mother or nursing infant, careful consideration of the individual risk/benefit ratio is necessary for certain agents, particularly those that are concentrated in human milk or result in exposures in the infant that may be clinically significant on the bases of relative infant dose or detectable serum concentrations,” researchers wrote. “Caution is also advised for drugs and agents with unproven benefits, with long half-lives that may lead to drug accumulation, or with known toxicity to the mother or infant.”

Disclosure: The researchers report no relevant financial disclosures.