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

Abstract

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.

Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION

“…By accounting for all the items listed above, researchers increase the likelihood that the only remaining plausible explanation for harm identified is the prescribed medicine. We made no recommendation in relation to breastfeeding, because no studies reported drug utilization during or preceding breastfeeding: very few databases hold data on breastfeeding [ 29 ].…”