MILK – PMX Africa

Systematic Review: Maternal-to-Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

11 February 2026

Read the full paper here Abstract: This review evaluates the available pharmacokinetic data on the plasma-to-breastmilk transfer of first- and second-line T2DM drugs against available clinical guideline recommendations. A list of drug therapies for treating T2DM was generated from national and international clinical guidelines. A systematic search of research articles reporting human plasma and breastmilk drug concentrations was conducted in Scopus, PubMed, Google Scholar, and LactMed® in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies evaluating breastmilk drug transfer in T2DM, with fully accessible abstract and main text reported in English, were included. Study quality was evaluated using the ClinPK checklist. Authors evaluated clinical guideline recommendations on the use of T2DM drugs in lactation and the basis upon which such recommendations were made. Only 5 out of 20 drugs (metformin, glyburide, glipizide, tolbutamide, and semaglutide) have clinical data on plasma-to-breastmilk transfer. Metformin and tolbutamide were detectable in maternal plasma and breastmilk. Half (51.7%) of guideline recommendations provide explicit guidance. Only 4.4% of recommendations were based on clinical evidence. Over half (57.8%) of recommendations were accessible online, and most guideline recommendations (78%) were against the use of antiglycemic agents while breastfeeding. The scarce clinical evidence to guide T2DM drug therapy during breastfeeding available has several design and methodological limitations. Published recommendations remain largely inconsistent, thus perpetuating uncertainty in the use of T2DM drug therapies in lactation. Addressing knowledge gaps is critical in developing clinical consensus to optimize T2DM drug therapy among breastfeeding mothers.

Review Paper: Treating Pregnant and Lactating Women: Insights from Clinical Pharmacology

26 January 2026

Read the full paper here Abstract: Pregnant and lactating women have historically been excluded from clinical trials, limiting data on drug pharmacokinetics, safety, and efficacy in these populations. Recent legislative frameworks have catalyzed efforts to include these populations in research. Quantitative pharmacology approaches such as PBPK support optimized trial designs, safer dosing regimens, and ethical research frameworks. Emerging technologies further enhance insights drug exposures in mother-infant dyads

Research Paper: Population pharmacokinetics of levofloxacin in breastmilk in patients with rifampicin-resistant tuberculosis

23 December 2025

Read the full paper here Abstract: Levofloxacin is a widely used antibiotic included in rifampicin-resistant tuberculosis (RR-TB) treatment. Data describing levofloxacin concentrations in breastmilk and infant exposure are limited. We analysed data from two South African studies of breastfeeding women receiving levofloxacin (750–1000 mg daily) for RR-TB. Plasma and breastmilk samples were collected over eight hours, ≥5 weeks postpartum. A single plasma sample was obtained from breastfed infants. Twenty women contributed paired plasma-breastmilk samples, 15 plasma concentrations from breastfed infants were available. Using nonlinear mixed-effects modelling, levofloxacin equilibrated rapidly between plasma and breastmilk (7.50 min half-life; 95% CI: 3.89–11.5), with a breastmilk: plasma ratio of 1.46 (95% CI: 1.40–1.52). The relative infant dose through breastfeeding was 6–8% of the recommended 15–20 mg/kg/day adult and paediatric dose, confirmed by low (but detectable) concentrations in some infants. It is unclear whether these low infant concentrations may be prophylactic or instead contribute to the development of drug resistance.

Research Paper: Prevalence, safety evidence, and determinants of medicine use during breastfeeding among women in Kampala, Uganda

23 August 2025

Read the full paper here Abstract: We conducted a cross-sectional study among 294 breastfeeding women aged 18 years and older with infants aged 12 months and below, attending six healthcare clinics in Kampala between September 2023 and January 2024. Using a structured questionnaire, we collected data on medicine use and breastfeeding practices.

Perspective: Clinical lactation studies. Acting on key recommendations over the last decade

26 February 2025

Read the full paper here Abstract: Including lactating women in clinical trials is imperative to generate relevant drug exposure and safety data needed to advise on clinical use of drugs in this understudied population. Recent changes in perspectives, regulatory guidance, and international networks which outline pragmatic approaches for advancing the conduct of clinical lactation studies are discussed.

[Research Paper] Culturally appropriate terminologies in health research: a participatory study with pregnant and breastfeeding mothers in Uganda

23 January 2025

Read this paper here The findings highlight the importance of using culturally sensitive language in health research to improve engagement and participation. By adopting community-preferred terms, researchers can avoid confusion and stigma. We offer guidance for future research, advocating for community-driven inclusive language in research involving pregnant and breastfeeding women. Background: The language used in research and health programs is crucial in influencing participation and ensuring the acceptability of programs and the adoption of research outcomes. The use of alienating language may present a barrier for research participants hence the need to identify accurate, respectful, relevant, and acceptable terms for respective study populations. The study explored commonly used terminologies during research involving pregnant and lactating mothers using public engagement and participatory approaches in Uganda.

[Research Paper] Population pharmacokinetic modeling of paired plasma–breast milk lamivudine data for estimation of infant exposure in breastfeeding mother–infant pairs

14 November 2024

Read the entire paper here Abstract: Around 1.2 million women living with HIV give birth annually, majority of whom will breastfeed their infants while receiving antiretroviral therapy (ART). Lamivudine, a component of first‐line ART regimens crosses from maternal plasma to breast milk, with measurable concentrations in some breastfed infants. Wide variability in plasma‐to‐breast milk transfer has been reported within‐ or across studies, probably due to differences in sampling framework. This work sought to characterize the milk‐to‐plasma transfer of lamivudine, quantify inter‐patient variability and associated factors, and predict exposure of a breastfed infant. We explored data from an observational pharmacokinetic study that included 35 Ugandan mothers and their infants. Mothers received lamivudine doses of 150 mg twice daily or 300 mg once daily as part of their antiretroviral regimen. Pharmacokinetic sampling was undertaken across two visits approximately 8 weeks apart, providing 248 maternal plasma, 256 breast milk‐, and 151 infant blood concentrations, measured across a 24‐h sampling interval. A one‐compartmental model best described the plasma disposition of lamivudine, with first‐order absorption, interindividual variability on clearance and volume of distribution, and a proportional residual error model. A lag in time of plasma‐to‐breast milk drug accumulation was described using an effect compartment model with a milk‐to‐plasma ratio of 1.77. An estimated daily infant dose of 179.3 μg/kg (range: 125.8, 282.3) closely predicted the observed infant steady‐state concentrations and translated into 3.34% (2.13, 7.20) and 3.35% (1.10, 7.15) of the standard daily maternal dose in visits 1 and 2, respectively. The established modeling framework can be extended to

[Research Paper] Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women

13 November 2024

Read the paper here Optimal dosing in pregnant and lactating women requires an understanding of the pharmacokinetics in the mother, fetus, and breastfed infant. Physiologically-based pharmacokinetic (PBPK) modeling can be used to simulate untested scenarios. A PBPK model for the antiretroviral dolutegravir was verified using reported exposures in non-pregnant healthy volunteers, pregnant women, and the umbilical cord, lactating mothers, and breastfed neonates. Abstract Optimal dosing in pregnant and lactating women requires an understanding of the pharmacokinetics in the mother, fetus, and breastfed infant. Physiologically‐based pharmacokinetic (PBPK) modeling can be used to simulate untested scenarios and hence supplement clinical data to support dosing decisions. A PBPK model for the antiretroviral dolutegravir (mainly metabolized by UGT1A1) was verified using reported exposures in non‐pregnant healthy volunteers, pregnant women, and the umbilical cord, lactating mothers, and breastfed neonates. The model was then applied to predict the impact of UGT1A1 phenotypes in extensive (EM), poor (PM), and ultra‐rapid metabolizers (UM). The predicted dolutegravir maternal plasma and umbilical cord AUC in UGT1A1 PMs was 1.6‐fold higher than in EMs. The predicted dolutegravir maternal plasma and umbilical cord AUC in UGT1A1 UMs mothers was 1.3‐fold lower than in EMs. The predicted mean systemic and umbilical vein concentrations were in excess of the dolutegravir IC90 at 17, 28, and 40 gestational weeks, regardless of UGT1A1 phenotype, indicating that the standard dose of dolutegravir (50 mg q.d., fed state) is generally appropriate in late pregnancy, across UGT1A1 phenotypes. Applying the model in breastfed infants, a 1.5‐, 1.7‐, and 2.2‐fold higher exposure

Research Paper: Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother-infant pairs

13 November 2024

Read this commentary here The objectives of this interim analysis were to define the transfer of rifampicin to a breastfed infant and to determine the area under the concentration-time curve of rifampicin in maternal plasma, breastmilk and infant plasma. Performing this interim analysis enabled us to substantiate whether prior assumptions we made on several study design issues including patient sample size and pharmacokinetic sampling times held and whether we needed to amend our protocol or not. Abstract Pharmacokinetic studies are important for understanding drug disposition in the human body. However, pregnant and lactating women are often excluded from primary pharmacokinetic studies and as such there is often limited dosing information regarding drug use in pregnant and/or lactating women. The objectives of this interim analysis were to define the transfer of rifampicin to a breastfed infant and to determine the area under the concentration–time curve of rifampicin in maternal plasma, breastmilk and infant plasma. Performing this interim analysis enabled us to substantiate whether prior assumptions we made on several study design issues including patient sample size and pharmacokinetic sampling times held and whether we needed to amend our protocol or not. We enrolled lactating mothers on treatment for tuberculosis with their breastfeeding infants (below 12 months of age), performed intensive pharmacokinetic sampling (0–24 h post‐dose) on plasma samples from both the mother, infant(s) and breastmilk samples from the mother on two separate occasions (once during the initiation phase and another during the continuation phase of tuberculosis treatment). The initial study design, including sampling

[Commentary] Recruitment of pregnant and breastfeeding women in pharmacokinetic studies: strategies, opportunities, barriers, and recommendations

17 October 2024

Pregnant and breastfeeding women are often under-represented in clinical research, including pharmacokinetic studies, due to ethical and logistical challenges. This paper examines strategies to improve the recruitment and retention of this demographic in pharmacokinetic research, drawing on experiences from five studies conducted at the Infectious Diseases Institute, Makerere University, Uganda.

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Systematic Review: Maternal-to-Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

Review Paper: Treating Pregnant and Lactating Women: Insights from Clinical Pharmacology

Research Paper: Population pharmacokinetics of levofloxacin in breastmilk in patients with rifampicin-resistant tuberculosis

Research Paper: Prevalence, safety evidence, and determinants of medicine use during breastfeeding among women in Kampala, Uganda

Perspective: Clinical lactation studies. Acting on key recommendations over the last decade

[Research Paper] Culturally appropriate terminologies in health research: a participatory study with pregnant and breastfeeding mothers in Uganda

[Research Paper] Population pharmacokinetic modeling of paired plasma–breast milk lamivudine data for estimation of infant exposure in breastfeeding mother–infant pairs

[Research Paper] Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women

Research Paper: Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother-infant pairs

[Commentary] Recruitment of pregnant and breastfeeding women in pharmacokinetic studies: strategies, opportunities, barriers, and recommendations

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