The American Academy of Pediatrics (AAP) policy statement on breast-feeding recommends that women breast-feed their infants exclusively for at least the first six months of life and suggests trying to breast-feed for the first 12 months of life.1 One of the many objectives of Healthy People 2010 is to have 75% of mothers initiating breast-feeding, 50% of mothers breast-feeding for the first six months, and 25% of mothers breast-feeding for the first 12 months. According to the 2005 National Immunization Survey, only five states have achieved all three of these objectives, with 21 states achieving the goal of mothers initiating breast-feeding. As health care professionals encourage more women to breast-feed, medication use while breast-feeding will increase. It is important for pharmacists to understand the effects of OTCmedications in women who are breast-feeding in order to make appropriate recommendations.
Transfer of Drugs into Breast Milk
Most medications will transfer into breast milk; however, the degree of transfer depends on several factors. Drugs may transfer into milk if they attain high concentrations in maternal plasma, have a low molecular weight (<500 Da), are low in protein binding, and are lipid soluble. During the first week of breast-feeding, when colostrum is produced, there are large gaps between the alveolar cells that enhance the passage of drugs into milk. However, the quantity of milk produced at this time is low (<30 to 100 mL/day), so the absolute dose transferred is minimal. After the first week, the presence of prolactin closes the gaps, reducing the entry of most maternal drugs and other substances into the milk compartment.
Safety Data and Breast-feeding
Unlike pregnancy, which has established FDA categories for medications, breast-feeding lacks standardized risk categories. Most of the data on medications and breast-feeding are from scientific literature. More information on lactation risk categories can be found in Tables 1 and 2.
Given the lack of safety standardization, other recommendations for using medications while breast-feeding include choosing drugs with short half-lives, high protein binding, low oral bioavailability, or high molecular weight. Other options to decrease infant exposure to the drug are taking the medication immediately after breast-feeding and avoiding long-acting formulations. Additionally, a clinician should choose a medication with published safety data rather than a newly introduced medication.
Analgesics
Many OTC options for analgesics are available. Acetaminophen is routinely used for fever and pain in infants, and levels excreted into breast milk are expected to be less than the dose given to infants.
Of the NSAIDs, ibuprofen is considered the drug of choice for breast-feeding women and is used routinely in infants. While ibuprofen is excreted into breast milk, the concentration and subsequent transfer to the infant are very low.
Naproxen should be used cautiously in breast-feeding women due to its long half-life. One case report documented prolonged bleeding, anemia, and thrombocytopenia in a 7-day-old infant whose mother was taking naproxen while breast-feeding.
Aspirin is excreted into breast milk in low concentrations. It has a slower excretion from breast milk than from plasma. The risk of Reye's syndrome due to aspirin in breast milk is unknown. Alternative therapeutic options are recommended; if aspirin is taken, the mother should avoid breast-feeding for one to two hours after the dose.
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