Evidence mapPaperPMID 27878468Full record

SynthesisDrug safety2017

The Risk of Adverse Pregnancy Outcome After First Trimester Exposure to H1 Antihistamines: A Systematic Review and Meta-Analysis.

Fatma Etwel, Lauren H Faught, Michael J Rieder, Gideon Koren

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. The impact and management of hyperemesis gravidarum: Current and future perspectives.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Review
  5. International survey of treatment practices for atopic dermatitis in pregnant and breastfeeding women: Physician perspectives.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Article
  6. Article
  7. How do you Zzz during pregnancy? A brief review of Z-drug use and management of insomnia during pregnancy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Review
  8. Observational
  9. Observational
  10. [Ophthalmic agents during pregnancy].Die Ophthalmologie · 2024
    Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Frontiers in cell and developmental biology · 2023
    Article
  16. Urticaria in Pregnancy and Lactation.Frontiers in allergy · 2022
    Review
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Fatma EtwelDepartment of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, Health Sciences Addition Room 222, London, ON, N6A 5C1, Canada.
Lauren H FaughtDepartment of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, Health Sciences Addition Room 222, London, ON, N6A 5C1, Canada.
Michael J RiederDepartment of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, Health Sciences Addition Room 222, London, ON, N6A 5C1, Canada.
Gideon KorenDepartment of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, Health Sciences Addition Room 222, London, ON, N6A 5C1, Canada. gidiup_2000@yahoo.com.
Western University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionH1 antihistamines are used for the treatment of nausea and vomiting during pregnancy as well as the symptomatic relief of asthma, urticaria, allergy, and the common cold. Although they are overall felt to be safe during pregnancy, recently several studies have challenged this assumption, as millions of women are exposed to them in the first trimester.

methodsFollowing the guidelines of PRISMA, a systematic review was performed to retrieve all published articles involving H1-antihistamine exposure during pregnancy. Electronic databases including PubMed and EMBASE were searched for possibly relevant articles published in any language up to December 2015.

resultsAfter removing duplicate publications, and excluding animal studies and studies on drug effectiveness, 342 articles were reviewed in detail and 37 studies fulfilled the inclusion criteria for the meta-analysis. In cohort studies, the risk of major malformation in the offspring of women exposed to H1 antihistamines was not higher than that of the control population (OR 1.07; 95% CI 0.98-1.16). The Q-statistic for heterogeneity of effects was not significant (p > 0.05, I

conclusionsBased on our meta-analyses, which included a large number of studies, H1 antihistamines are not associated with an increased risk of major malformation or other adverse fetal outcomes. This study provides important information to both pregnant women and their healthcare providers regarding the safety and risk of H1 antihistamine use during this sensitive time.

Indexed as

Pregnancy OutcomeAbnormalities, Drug-InducedFemaleHistamine H1 AntagonistsHumansPregnancyPregnancy ComplicationsPregnancy Trimester, FirstRiskHistamine H1 Antagonists

Identifiers

PMID27878468
OpenAlexW2553006099

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.