2014
DOI: 10.1186/1475-2875-13-197
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Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort

Abstract: BackgroundThere is limited data available regarding safety profile of artemisinins in early pregnancy. They are, therefore, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. The study assessed birth outcome among pregnant women inadvertently exposed to artemether-lumefantrine (AL) during first trimester in comparison to those of women exposed to other anti-malarial drugs or no drug at all during the same period of pregnan… Show more

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Cited by 33 publications
(50 citation statements)
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References 19 publications
(25 reference statements)
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“…Although preclinical safety signals were seen in many experimental species, no overt increase in birth defects or early abortions have been seen with artemisinin use in humans. To establish that there was not a twofold increase in the risk of such an event, an analysis of some 800 reported inadvertent ACT exposures in first-trimester pregnancy was needed [39, 94, 95]. For any new medicine, it would usually be at least a decade after launch before such data were available, underlying the need for more investment in the post-registration safety monitoring in disease-endemic countries.…”
Section: Selecting Medicines For Use In Pregnancy and Small Childrenmentioning
confidence: 99%
“…Although preclinical safety signals were seen in many experimental species, no overt increase in birth defects or early abortions have been seen with artemisinin use in humans. To establish that there was not a twofold increase in the risk of such an event, an analysis of some 800 reported inadvertent ACT exposures in first-trimester pregnancy was needed [39, 94, 95]. For any new medicine, it would usually be at least a decade after launch before such data were available, underlying the need for more investment in the post-registration safety monitoring in disease-endemic countries.…”
Section: Selecting Medicines For Use In Pregnancy and Small Childrenmentioning
confidence: 99%
“…The studies were included from 11 East African countries. Nineteen studies were from Tanzania [33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51]…”
Section: Study Characteristicsmentioning
confidence: 99%
“…These include extreme maternal age (<20 and >35 years), obesity, parity, history of miscarriage, history of preterm delivery, period on titis history of abortion, low social economic status and alcohol use, living in rural areas, use of herbal medicine, maternal anaemia, diabetes mellitus, shoulder dystocia, hypertension, premature rupture of membrane (PROM), untreated bacterial vaginosis, human immune deficiency virus infection (HIV) and Escherichia coli infection [3,[4][5][6][7][8][9][10][11][12][13][14][15][16][17][18].…”
Section: Introductionmentioning
confidence: 99%