Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review.

INTRODUCTION: Information on the impact of medicines on breastfeeding and the breastfed infant remains scarce. The aims of this review were to identify databases and cohorts holding this information, and pinpoint current information and research deficits. METHOD: We searched 12 electronic databases, including PubMed/ Medline and Scopus, using a combination of controlled vocabulary (MeSH terms) and free text terms. We included studies reporting data from databases with information on breastfeeding, medicines exposure, and infant outcomes. We excluded studies not reporting all three parameters. Two reviewers independently selected papers and extracted data using a standardised spreadsheet. Risk of bias was assessed. Recruited cohorts with relevant information were tabulated separately. Discrepancies were resolved by discussion. RESULTS: From 752 unique records, 69 studies were identified for full review. Eleven papers reported analyses from ten established databases with information on maternal prescription or non-prescription drugs, breastfeeding and infant outcomes. Twenty-four cohort studies were also identified. No studies reported educational or long-term developmental outcomes. The data are too sparse to warrant any firm conclusions, beyond the need for more data. The overall picture hints at 1) unquantifiable, but probably rare, serious harms to infants exposed to medicines via breastmilk, 2) unknown long-term harms, and 3) a more insidious but more pervasive harm in terms of reduced breastfeeding rates following medicines exposure in late pregnancy and peri-partum. IMPLICATIONS: Analyses of databases reporting on the full population are needed to quantify any adverse effects of medicines and identify dyads at risk of harm from prescribed medicines while breastfeeding. This information is essential to ensure 1) infants are monitored appropriately for any adverse drug reactions 2) inform breastfeeding patients using long-term medicines as to whether the benefits of breastfeeding outweigh exposure to medicines via breastmilk and 3) target additional support to breastfeeding patients whose medicines may affect breastfeeding. The protocol is registered with the Registry of Systematic Reviews, no.994.

Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert.

BACKGROUND: The pharmacoepidemiology of the long-term benefits and harms of medicines in pregnancy and breastfeeding has received little attention. The impact of maternal medicines on children is increasingly recognised as a source of avoidable harm. The focus of attention has expanded from congenital anomalies to include less visible, but equally important, outcomes, including cognition, neurodevelopmental disorders, educational performance, and childhood ill-health. Breastfeeding, whether as a source of medicine exposure, a mitigator of adverse effects or as an outcome, has been all but ignored in pharmacoepidemiology and pharmacovigilance: a significant 'blind spot'. WHOLE-POPULATION DATA ON BREASTFEEDING: WHY WE NEED THEM: Optimal child development and maternal health necessitate breastfeeding, yet little information exists to guide families regarding the safety of medicine use during lactation. Breastfeeding initiation or success may be altered by medicine use, and breastfeeding may obscure the true relationship between medicine exposure during pregnancy and developmental outcomes. Absent or poorly standardised recording of breastfeeding in most population databases hampers analysis and understanding of the complex relationships between medicine, pregnancy, breastfeeding and infant and maternal health. The purpose of this paper is to present the arguments for breastfeeding to be included alongside medicine use and neurodevelopmental outcomes in whole-population database investigations of the harms and benefits of medicines during pregnancy, the puerperium and postnatal period. We review: 1) the current situation, 2) how these complexities might be accommodated in pharmacoepidemiological models, using antidepressants and antiepileptics as examples; 3) the challenges in obtaining comprehensive data. CONCLUSIONS: The scarcity of whole-population data and the complexities of the inter-relationships between breastfeeding, medicines, co-exposures and infant outcomes are significant barriers to full characterisation of the benefits and harms of medicines during pregnancy and breastfeeding. This makes it difficult to answer the questions: 'is it safe to breastfeed whilst taking this medicine', and 'will this medicine interfere with breastfeeding and/ or infants' development'?

Differences in the emotional and practical experiences of exclusively breastfeeding and combination feeding mothers.

The majority of research examining the barriers to breastfeeding focuses on the physical challenges faced by mothers rather than the risks of encountering negative emotional and practical feeding experiences. We aimed to quantify the emotional and practical experiences of the overall sample of breastfeeding mothers and identify the differences in the emotional and practical experiences of exclusively breastfeeding mothers and combination feeding mothers, by feeding type and intention. Eight hundred forty-five mothers with infants up to 26 weeks of age and who had initiated breastfeeding were recruited through relevant social media via advertisements providing a link to an online survey. Predictors of emotional experiences included guilt, stigma, satisfaction with feeding method, and the need to defend themselves due to infant feeding choices. Practical predictors included perceived support from health professionals, main sources of infant feeding information, and respect from their everyday environment, workplace, and when breastfeeding in public. Current feeding type and prenatal feeding intention. In the overall sample, 15% of the mothers reported feeling guilty, 38% stigmatized, and 55% felt the need to defend their feeding choice. Binary logit models revealed that guilt and dissatisfaction were directly associated with feeding type, being higher when supplementing with formula. No associations with feeding intention were identified. This study demonstrates a link between current breastfeeding promotion strategies and the emotional state of breastfeeding mothers who supplement with formula to any extent. To minimize the negative impact on maternal well-being, it is important that future recommendations recognize the challenges that exclusive breastfeeding brings and provide a more balanced and realistic target for mothers.

The emotional and practical experiences of formula-feeding mothers.

The majority of infant-feeding research is focused on identifying mother's reasons for the cessation of breastfeeding. The experience of mothers who choose to use formula is largely overlooked in quantitative designs. This study aimed to describe the emotional and practical experiences of mothers who formula feed in any quantity, and examine whether these experiences would vary among different cohorts of formula-feeding mothers according to prenatal feeding intention and postnatal feeding method. A total of 890 mothers of infants up to 26 weeks of age, who were currently formula feeding in any quantity, were recruited through relevant international social media sites via advertisements providing a link to an online survey. Predictors of emotional experiences included guilt, stigma, satisfaction, and defense as a result of their infant feeding choices. Practical predictor variables included support received from health professionals, respect displayed by their everyday environment, and main sources of infant feeding information. Descriptive findings from the overall sample highlighted a worryingly high percentage of mother's experienced negative emotions as a result of their decision to use formula. Multinomial logit models revealed that negative emotions such as guilt, dissatisfaction, and stigma were directly associated with feeding intention and method. The evidence suggests that the current approach to infant-feeding promotion and support may be paradoxically related to significant issues with emotional well-being. These findings support criticisms of how infant-feeding recommendations are framed by health care professionals and policy makers, and highlight a need to address formula feeding in a more balanced, woman-centered manner.