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Cited by 68Malaria Research and ControlPregnancy and Medication ImpactGlobal Maternal and Child Health

Safety of artemether-lumefantrine in pregnant women with malaria: results of a prospective cohort study in Zambia

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Manyando, Christine, Mkandawire, Rhoda, Puma, Lwipa, Sinkala, Moses, Mpabalwani, Evans, Njunju, Eric, Gomes, Melba, Ribeiro, Isabela +6 more·2010·Malaria Journal
DOI 10.1186/1475-2875-9-249PMC PMC2944339
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Abstract

BACKGROUND: Safety data regarding exposure to artemisinin-based combination therapy in pregnancy are limited. This prospective cohort study conducted in Zambia evaluated the safety of artemether-lumefantrine (AL) in pregnant women with malaria. METHODS: Pregnant women attending antenatal clinics were assigned to groups based on the drug used to treat their most recent malaria episode (AL vs. sulphadoxine-pyrimethamine, SP). Safety was assessed using standard and pregnancy-specific parameters. Post-delivery follow-up was six weeks for mothers and 12 months for live births. Primary outcome was perinatal mortality (stillbirth or neonatal death within seven days after birth). RESULTS: Data from 1,001 pregnant women (AL n = 495; SP n = 506) and 933 newborns (AL n = 466; SP n = 467) showed: perinatal mortality (AL 4.2%; SP 5.0%), comprised of early neonatal mortality (each group 2.3%), stillbirths (AL 1.9%; SP 2.7%); preterm deliveries (AL 14.1%; SP 17.4% of foetuses); and gestational age-adjusted low birth weight (AL 9.0%; SP 7.7%). Infant birth defect incidence was 1.8% AL and 1.6% SP, excluding umbilical hernia. Abortions prior to antenatal care could not be determined: abortion occurred in 4.5% of women treated with AL during their first trimester; none were reported in the 133 women exposed to SP and/or quinine during their first trimester. Overall development (including neurological assessment) was similar in both groups. CONCLUSIONS: These data suggest that exposure to AL in pregnancy, including first trimester, is not associated with particular safety risks in terms of perinatal mortality, malformations, or developmental impairment. However, more data are required on AL use during the first trimester.

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  • Artemisinin derivatives were relatively safe (n=1937) in the first trimester of pregnancy.

    “Artemisinin derivatives were relatively safe (n=1937) in the first trimester of pregnancy42,118–119 and the cumulative failure rate reported in only one study was 6.6% across all trimesters (n=461).118”

    From Malaria in pregnancy. (2013) · cites this paper as [119]

    The Abstract Conclusions say that first-trimester exposure to artemether-lumefantrine was not associated with particular safety risks, while cautioning that more data are needed. The Discussion reports 156 first-trimester-exposed women, not 1,937, and the study concerns artemether-lumefantrine rather than artemisinin derivatives generally. Page numbers are not available in our copy. (LLM, conf=0.87)

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  • No major adverse event was observed in 377 women with known pregnancy outcome and exposed to artemisinins in the first trimester.

    “No major adverse event was observed in 377 women with known pregnancy outcome and exposed to artemisinins in the first trimester.42,119–121”

    From Malaria in pregnancy. (2013) · cites this paper as [119]

    The Discussion reports 156 women exposed to artemether-lumefantrine in the first trimester, not 377, and says the reported birth defects, excluding trisomy, were not considered major. The Results section on first-trimester exposure reports six abortions among 159 exposed foetuses, so this paper does not support an unqualified claim that no major adverse event was observed. (LLM, conf=0.87)

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Research works printed but not linked: 1

  1. Clark RL Kumemura M Makori Nakata Y Bernard F Harrell A White TEK Arima A Artesunate: developmental toxicity in monkeys Birth Defects Res 2006 76 329 [Abstract] 18702116

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Authors
Manyando, C., Mkandawire, R., Puma, L., Sinkala, M., Mpabalwani, E., Njunju, E., Gomes, M., Ribeiro, I., Walter, V., Virtanen, M., Schlienger, R., Cousin, M., Chipimo, M., & Sullivan, F. M.
Affiliations
  • Tropical Diseases Research Centre (ZM)
  • Ministry of Health (ZM)
  • University Teaching Hospital (ZM)
  • World Health Organization (CH)
  • Novartis (Switzerland) (CH)
  • United Nations Children's Fund (US)
  • University of London (GB)
Corresponding author
Manyando, Christine
ORCID
Venue
Malaria Journal
Publisher
Springer Science and Business Media LLC
Published
2010-09-01
Volume
9
Issue
1
Pages
249-249
ISSN
1475-2875 (ISSN-L)
DOI
10.1186/1475-2875-9-249
PMC
PMC2944339
OpenAlex
W2164779304
Cited by
67
References
37
Citations by year
2025: 1 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 6 · 2019: 1 · 2018: 3 · 2017: 7 · 2016: 4 · 2015: 7 · 2014: 13 · 2013: 5 · 2012: 8
FWCI
6.36
Type
journal article
Language
en
Open access
Licence
Locations
  • Malaria Journal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Greater South Information System
Funders
Novartis Pharma
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
Keywords
artemether-lumefantrine, sulfadoxine-pyrimethamine, malaria in pregnancy, antimalarial drug safety, perinatal mortality, stillbirth, neonatal death, low birth weight, preterm birth, congenital malformations, first trimester exposure, quinine, Zambia
MeSH terms
Artemether, Lumefantrine Drug Combination, Adolescent, Adult, Antimalarials, Drug Combinations, Ethanolamines, Female, Fluorenes, Humans, Infant, Newborn, Malaria, Male, Pregnancy, Pregnancy Complications, Infectious, Prospective Studies, Zambia, Cohort Studies, Survival Analysis, Artemisinins, Perinatal Mortality, Young Adult

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