Drugs in lactation

Abstract

Although most medications can be taken safely during breastfeeding, potential risks of infant toxicity do exist because all medications will be excreted into the breast milk to some extent. The amount of medication excreted in the milk depends mainly on (i) within-drug variation, such as dosing; (ii) between-drug variation including chemical characteristics of the medication; and (iii) host factors, such as maternal pharmacokinetics (PK), including variations of pregnancy-associated changes and their post-partum recovery. Neonatal drug exposure is usually assessed by calculating an expected total infant daily dose through breast milk and comparing it to the normal therapeutic dose. However, clinical PK studies in this population are challenging to conduct. Recently, research methods using population PK analyses and physiologically-based PK modeling and simulation techniques have been recognized as a complementary approach to the conventional PK studies in this field. These efforts are important for rational risk assessment balancing the toxicity risk against the benefits of human milk. Health benefits of lactation for both mother and child are significant and a decision to withhold from this should not be taken lightly. In case limited information is present, additional expertise from pharmacists or clinical pharmacologist with expertise in this area should be sought.

Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease

“…All ADRs were readily identified by the pediatricians evaluating these children, many of which participated in this study. The overall observed incidence of ADRs in adults in our cohort (60%) is in agreement with the rate previously described in adults [37,13].…”

“…MP ratios are, in fact, not generally the preferred estimator of potential for infant drug exposure if other, better; indicators of degree of exposure risk are available such as RID. There is an abundance of examples in the literature of drugs that have high MP ratios but negligible infant exposures due to very low milk concentrations [37]. In the case of NF, the median MP ratio of 16 suggests a significant accumulation of NF in breastmilk.…”

The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications

“…Lactation is another critical consideration for using investigational products in pregnant women who are research participants. For pregnant women close to term, there is need to assess safety of investigational products during lactation [31]. While most medications can be taken safely during breastfeeding, the potential risks of infant toxicity do exist because all medications (to some extent) are excreted into breast milk [31].…”

“…For pregnant women close to term, there is need to assess safety of investigational products during lactation [31]. While most medications can be taken safely during breastfeeding, the potential risks of infant toxicity do exist because all medications (to some extent) are excreted into breast milk [31]. The extent to which secretion occur depends on within-drug variation (such as dosing), between-drug variation (such as chemical characteristics of the medication) and host factors (such as gestational age, maternal pharmacokinetics during pregnancy or puerperium and drug binding and metabolism) [31].…”

“…While most medications can be taken safely during breastfeeding, the potential risks of infant toxicity do exist because all medications (to some extent) are excreted into breast milk [31]. The extent to which secretion occur depends on within-drug variation (such as dosing), between-drug variation (such as chemical characteristics of the medication) and host factors (such as gestational age, maternal pharmacokinetics during pregnancy or puerperium and drug binding and metabolism) [31]. It is important for rational risk assessment to balance the toxicity risk from breast milk secretion against the potential benefits (of the research) and lactation, as the health potential benefits of both mother and child are significant.…”