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Safety of antimalarial drugs exposure during early pregnancy

Authors Tagbor H, Antwi G, Dogbe J

Received 10 February 2014

Accepted for publication 29 March 2014

Published 19 June 2014 Volume 2014:5 Pages 23—33


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 5

Video abstract presented by Harry Tagbor

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Harry Tagbor,1 Gifty Antwi,1 Joslin Dogbe2

1Department of Community Health, 2Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

Introduction: Inadequately controlled malaria infection in pregnancy is associated with poor maternal and fetal outcomes. However, there are important questions about drug safety for mothers with malaria and their fetuses as, currently, there is limited safety data on many of the medications used. The objective of this review is to determine from published evidence the safety of antimalarial drugs exposure during early pregnancy, focusing on abortions, stillbirths, and congenital abnormalities.
Methods: We searched PubMed, Embase, Cochrane Library, and Malaria in Pregnancy databases from their inception to June 2013, inclusive, for reports published in English only. Data were extracted on exposure to antimalarial drugs during early pregnancy and adverse pregnancy outcomes including congenital abnormalities, stillbirth, and miscarriage.
Results: Twenty-two publications including one abstract with a total of 6,333 early pregnancy exposures to antimalarial agents used for treatment and/or prevention of malaria in pregnancy met the inclusion criteria. More than 40% of the pregnancies were exposed to mefloquine, about 10% to artemisinin based regimens and, 15.2% and 14.7% were exposed to chloroquine and quinine, respectively. A total of 1,199 adverse outcomes including abortions, stillbirths, and congenital abnormalities were reported. The reported absolute risks of adverse outcomes were similar for all the antimalarial exposures, but, in two publications, increased risk of stillbirths was linked to mefloquine exposure. Extensive heterogeneity and variability in the way in which authors assessed, recorded, and reported safety data precluded formal meta-analysis.
Conclusion: The absolute estimates of risks obtained in the included studies are difficult to interpret and the clinical significance of any association of adverse outcomes reported with antimalarial exposure in early pregnancy is uncertain. Well planned, executed, and analyzed studies are needed to confirm whether there is increased risk for adverse fetal outcomes attributable to exposure of first trimester pregnancies to antimalarials compared to relevant controls.

Keywords: malaria in pregnancy, first trimester, antimalarials, adverse outcomes, mefloquine, congenital abnormalities

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