Ethical Issues in Use of Medications During Lactation

During pregnancy and lactation, medications given to mothers to treat medical conditions have the potential to impact the health and development of the fetus or infant. Women are often advised to protect their breastfed infant by avoiding the medication or not feeding the infant the affected milk. Although the decision to expose the fetus to a medication during pregnancy may be considered unavoidable, and therefore ethically defensible, exposing an infant to medication through human milk creates a unique ethical dilemma given that many stakeholders consider infant formula to be a reasonable alternative. Pharmaceutical companies may consider that testing their medications among women who are pregnant or breastfeeding is too risky, preferring to take the alternative approach of advising that parents who are pregnant or breastfeeding should not use their product. This approach of risk avoidance has directly contributed to a lack of evidence pertaining to the safety and efficacy of many medications during pregnancy and lactation and resulted in clinicians prescribing medications to this population “off-label.” The purpose of this article is to address ethical issues that should be considered in the development of evidence as well as decision making about medication use in breastfeeding women when viewed from a public health perspective