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Clin Infect Dis. 2012 Jun;54(11):e124-31. doi: 10.1093/cid/cis215. Epub 2012 Apr 10.

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

Author information

1
Division of Epidemiology and Communicable Diseases, University of Zurich Centre for Travel Medicine, Institute for Social and Preventive Medicine, Zurich, Switzerland. pat@ifspm.uzh.ch

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.

PMID:
22495078
PMCID:
PMC3348951
DOI:
10.1093/cid/cis215
[Indexed for MEDLINE]
Free PMC Article

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