ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
Primaquine Pharmacokinetics in Lactating Women and Breastfed Infant Exposures.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01780753 (A Study of the Pharmacokinetics of Primaquine in Lactating Women and Breastfed Infants for the Radical Treatment of Uncomplicated Maternal P. Vivax), which is not on this map. Cited by 27 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study of the Pharmacokinetics of Primaquine in Lactating Women and Breastfed Infants for the Radical Treatment of Uncomplicated Maternal P. Vivax
Who cites it
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases.PLoS neglected tropical diseases · 2023Pooled it
- Tafenoquine: a toxicity overview.Expert opinion on drug safety · 2021Pooled it
- Primaquine at alternative dosing schedules for preventing relapse in people with Plasmodium vivax malaria.The Cochrane database of systematic reviews · 2019Pooled it
- Population pharmacokinetics of primaquine and its metabolites in African males.Malaria journal · 2024Trial
- Cohort Profile: the SMRU Refugee and Migrant Pregnancy Study in Western Thailand and Eastern Myanmar.Wellcome open research · 2026Article
- Tafenoquine lactation pharmacokinetics: a pilot study.Malaria journal · 2025Article
- Malaria: past, present, and future.Signal transduction and targeted therapy · 2025Review
- PBPK-Led Assessment of Antimalarial Drug Concentrations in Breastmilk: A Strategy for Optimal Use of Prediction Methods to Guide Decision Making in an Understudied Population.CPT: pharmacometrics & systems pharmacology · 2025Article
- A tutorial on physiologically based pharmacokinetic approaches in lactation research.CPT: pharmacometrics & systems pharmacology · 2024Article
- Addressing health equity for breastfeeding women: primaquine for Plasmodium vivax radical cure.Malaria journal · 2024Review
- Population pharmacokinetic modelling of primaquine exposures in lactating women and breastfed infants.Nature communications · 2024Article
- Supplementing clinical lactation studies with PBPK modeling to inform drug therapy in lactating mothers: Prediction of primaquine exposure as a case example.CPT: pharmacometrics & systems pharmacology · 2024Article
- Factors hindering coverage of targeted mass treatment with primaquine in a malarious township of northern Myanmar in 2019-2020.Scientific reports · 2023Article
- Plasmodium vivax in Children: Hidden Burden and Conspicuous Challenges, a Narrative Review.Infectious diseases and therapy · 2023Review
- Plasmodium vivax: the potential obstacles it presents to malaria elimination and eradication.Tropical diseases, travel medicine and vaccines · 2022Review
- Is it time for Africa to adopt primaquine in the era of malaria control and elimination?Tropical medicine and health · 2022Review
- Reference spectrophotometric values for glucose-6-phosphate dehydrogenase activity in two-to six-month-old infants on the Thailand-Myanmar border.Wellcome open research · 2022Article
- Current investigations on clinical pharmacology and therapeutics of Glucose-6-phosphate dehydrogenase deficiency.Pharmacology & therapeutics · 2021Review
- The prevention and treatment of Plasmodium vivax malaria.PLoS medicine · 2021Article
- Transplacental Transfer of Primaquine and Neurobehavioral Development of Prenatally Exposed Rats.Journal of toxicology · 2021Article
Corrections and comments
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Authors and funding
13 authors at 4 institutions in 2 countries.
Funding
Abstract
Background: Primaquine is the only drug providing radical cure of Plasmodium vivax malaria. It is not recommended for breastfeeding women as it causes hemolysis in glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals, and breast milk excretion and thus infant exposure are not known. Methods: Healthy G6PD-normal breastfeeding women with previous P. vivax infection and their healthy G6PD-normal infants between 28 days and 2 years old were enrolled. Mothers took primaquine 0.5 mg/kg/day for 14 days. Primaquine and carboxyprimaquine concentrations were measured in maternal venous plasma, capillary plasma, and breast milk samples and infant capillary plasma samples taken on days 0, 3, 7, and 13. Results: In 20 mother-infant pairs, primaquine concentrations were below measurement thresholds in all but 1 infant capillary plasma sample (that contained primaquine 2.6 ng/mL), and carboxyprimaquine was likewise unmeasurable in the majority of infant samples (maximum value 25.8 ng/mL). The estimated primaquine dose received by infants, based on measured breast milk levels, was 2.98 µg/kg/day (ie, ~0.6% of a hypothetical infant daily dose of 0.5 mg/kg). There was no evidence of drug-related hemolysis in the infants. Maternal levels were comparable to levels in nonlactating patients, and adverse events in mothers were mild. Conclusions: The concentrations of primaquine in breast milk are very low and therefore very unlikely to cause adverse effects in the breastfeeding infant. Primaquine should not be withheld from mothers breastfeeding infants or young children. More information is needed in neonates. Clinical Trials Registration: NCT01780753.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.