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Cited by 57Pregnancy and Medication ImpactPharmacological Effects and Toxicity StudiesPharmacovigilance and Adverse Drug Reactions

Pregnancy and Fetal Outcomes After Exposure to Mefloquine in the Pre- and Periconception Period and During Pregnancy

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Schlagenhauf, P., Blumentals, W. A., Suter, P., Regep, L., Vital-Durand, G., Schaerer, M. T., Boutros, M. S., Rhein, H.-G. +1 more·2012·Clinical Infectious Diseases
DOI 10.1093/cid/cis215PMC PMC3348951
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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.

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  • Data available indicate that ACTs are relatively safe for the foetus when taken after the first trimester of pregnancy.

    “Data available indicate that ACTs are relatively safe for the foetus when taken after the first trimester of pregnancy.”

    From Malaria in pregnancy. (2013) · cites this paper as [130]

    The Methods and Discussion examine fetal outcomes after exposure to mefloquine, not artemisinin-based combination therapies (ACTs). A Discussion passage calls mefloquine a potential partner drug in future artemisinin combination treatments, but our copy does not assess whether ACTs are safe for the fetus after the first trimester (searched: ACTs and artemisinin combination treatments). (LLM, conf=0.78)

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Research works printed but not linked: 25

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Authors
Schlagenhauf, P., Blumentals, W. A., Suter, P., Regep, L., Vital-Durand, G., Schaerer, M. T., Boutros, M. S., Rhein, H.-G., & Adamcova, M.
Affiliations
  • University of Zurich (CH)
  • F. Hoffmann-La Roche AG (CH)
ORCID
Schlagenhauf, P.
Venue
Clinical Infectious Diseases
Publisher
Oxford University Press (OUP)
Published
2012-04-10
Volume
54
Issue
11
Pages
e124-e131
ISSN
  • 1058-4838 (ISSN-L)
  • 1537-6591
DOI
10.1093/cid/cis215
PMC
PMC3348951
OpenAlex
W2113485405
Cited by
57
References
1
Citations by year
2025: 1 · 2024: 1 · 2023: 1 · 2020: 2 · 2019: 4 · 2018: 8 · 2017: 3 · 2016: 5 · 2015: 5 · 2014: 14 · 2013: 8 · 2012: 5
FWCI
9.89
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Clinical Infectious Diseases (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
  • reroDoc Digital Library (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
  • Zurich Open Repository and Archive (University of Zurich)
Funders
  • GlaxoSmithKline
  • F. Hoffmann-La Roche
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
mefloquine, pregnancy, fetal outcomes, congenital malformations, fetal death, abortion, malaria chemoprophylaxis, drug safety, paternal exposure, periconception period, first trimester
MeSH terms
Abnormalities, Drug-Induced, Abortion, Spontaneous, Adolescent, Adult, Antimalarials, Female, Humans, Infant, Newborn, Malaria, Middle Aged, Pregnancy, Pregnancy Complications, Infectious, Mefloquine, Prevalence, Chemoprevention, Young Adult

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