Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort.

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Serval ID
serval:BIB_BB36626BAE4A
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort.
Journal
Malaria Journal
Author(s)
Mosha D., Mazuguni F., Mrema S., Sevene E., Abdulla S., Genton B.
ISSN
1475-2875 (Electronic)
ISSN-L
1475-2875
Publication state
Published
Issued date
2014
Peer-reviewed
Oui
Volume
13
Number
1
Pages
197
Language
english
Notes
Publication types: Journal Article Publication Status: epublish PDF : Research
Abstract
BACKGROUND: There 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 pregnancy.
METHODS: Pregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery.
RESULTS: 2167 pregnant women were recruited and 1783 (82.3%) completed the study until delivery. 319 (17.9%) used anti-malarials in first trimester, of whom 172 (53.9%) used (AL), 78 (24.4%) quinine, 66 (20.7%) sulphadoxine-pyrimethamine (SP) and 11 (3.4%) amodiaquine. Quinine exposure in first trimester was associated with an increased risk of miscarriage/stillbirth (OR 2.5; 1.3-5.1) and premature birth (OR 2.6; 1.3-5.3) as opposed to AL with (OR 1.4; 0.8-2.5) for miscarriage/stillbirth and (OR 0.9; 0.5-1.8) for preterm birth. Congenital anomalies were identified in 4 exposure groups namely AL only (1/164[0.6%]), quinine only (1/70[1.4%]), SP (2/66[3.0%]), and non-anti-malarial exposure group (19/1464[1.3%]).
CONCLUSION: Exposure to AL in first trimester was more common than to any other anti-malarial drugs. Quinine exposure was associated with adverse pregnancy outcomes which was not the case following other anti-malarial intake. Since AL and quinine were used according to their availability rather than to disease severity, it is likely that the effect observed was related to the drug and not to the disease itself. Even with this caveat, a change of policy from quinine to AL for the treatment of uncomplicated malaria during the whole pregnancy period could be already envisaged.
Pubmed
Web of science
Open Access
Yes
Create date
20/06/2014 17:27
Last modification date
20/08/2019 15:29
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