Header

UZH-Logo

Maintenance Infos

Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy


Schlagenhauf, Patricia; Blumentals, William A; Suter, Pia; Regep, Loredana; Vital-Durand, Gabriel; Schaerer, Martin T; Boutros, Margarita Suarez; Rhein, Hans-Georg; Adamcova, Miriam (2012). Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy. Clinical Infectious Diseases, 54(11):e124-e131.

Abstract

Background: Pregnant women who travel to malarious areas and their clinicians need data on the safety of malaria chemoprophylaxis.
Methods: The effect of exposure to mefloquine on pregnancy and offspring outcomes was evaluated using the F. Hoffmann-La Roche global drug safety database for the time frame 31 January 1986 through 26 October 2010. We investigated pregnancy and fetal outcomes in maternal, paternal, and both-parent exposure cases with a focus on congenital malformations and fetal loss. The main outcome measures were birth defect prevalence and types of malformations.
Results: A total of 2506 cases of mefloquine exposure during pregnancy or in the pre- and periconception period were evaluated. Most cases were maternal prospective (outcome of the pregnancy unknown at the time of reporting; n = 2246 [89.6%]) followed by maternal retrospective cases (outcome of the pregnancy known at the time of reporting; n = 227 [9.0%]), with small numbers of paternal and both-parent exposure cases. Of the total 2246 mefloquine maternal prospective exposures (95.2%), 2139 occurred before conception and/or during the first trimester. Of 1383 maternal prospective cases with known outcome, 978 (70.7%) resulted in delivery, 405 (29.3%) resulted in abortion (112 spontaneous, 293 therapeutic), and 43 resulted in birth defects, corresponding to a birth defect prevalence of 4.39% (43 of 978). Prospective cases overall showed no specific pattern of birth malformations.
Conclusions: The drug safety database analysis of mefloquine exposure in pregnancy showed that the birth defect prevalence and fetal loss in maternal, prospectively monitored cases were comparable to background rates.

Abstract

Background: Pregnant women who travel to malarious areas and their clinicians need data on the safety of malaria chemoprophylaxis.
Methods: The effect of exposure to mefloquine on pregnancy and offspring outcomes was evaluated using the F. Hoffmann-La Roche global drug safety database for the time frame 31 January 1986 through 26 October 2010. We investigated pregnancy and fetal outcomes in maternal, paternal, and both-parent exposure cases with a focus on congenital malformations and fetal loss. The main outcome measures were birth defect prevalence and types of malformations.
Results: A total of 2506 cases of mefloquine exposure during pregnancy or in the pre- and periconception period were evaluated. Most cases were maternal prospective (outcome of the pregnancy unknown at the time of reporting; n = 2246 [89.6%]) followed by maternal retrospective cases (outcome of the pregnancy known at the time of reporting; n = 227 [9.0%]), with small numbers of paternal and both-parent exposure cases. Of the total 2246 mefloquine maternal prospective exposures (95.2%), 2139 occurred before conception and/or during the first trimester. Of 1383 maternal prospective cases with known outcome, 978 (70.7%) resulted in delivery, 405 (29.3%) resulted in abortion (112 spontaneous, 293 therapeutic), and 43 resulted in birth defects, corresponding to a birth defect prevalence of 4.39% (43 of 978). Prospective cases overall showed no specific pattern of birth malformations.
Conclusions: The drug safety database analysis of mefloquine exposure in pregnancy showed that the birth defect prevalence and fetal loss in maternal, prospectively monitored cases were comparable to background rates.

Statistics

Citations

28 citations in Web of Science®
30 citations in Scopus®
Google Scholar™

Altmetrics

Downloads

92 downloads since deposited on 15 Oct 2012
14 downloads since 12 months
Detailed statistics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Epidemiology, Biostatistics and Prevention Institute (EBPI)
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:15 Oct 2012 11:55
Last Modified:06 Sep 2017 05:04
Publisher:University of Chicago Press
ISSN:1058-4838
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1093/cid/cis215
PubMed ID:22495078

Download

Download PDF  'Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy'.
Preview
Content: Published Version
Filetype: PDF
Size: 112kB
View at publisher