Evidence map›Paper›PMID 25797654›Full record

SynthesisReproductive toxicology (Elmsford, N.Y.)2015

First trimester exposure to topiramate and the risk of oral clefts in the offspring: A systematic review and meta-analysis.

Abdulaziz M S Alsaad, Shahnaz Akthar Chaudhry, Gideon Koren

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Reproductive toxicology (Elmsford, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
12.6field-weighted citation impact, top 2% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Risk Management of Valproate and Other Teratogenic Anticonvulsants in the Era of Proliferating Use.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  4. Article
  5. Approach to Obesity Treatment in Primary Care: A Review.JAMA internal medicine · 2024 · on this map
    Review
  6. Prenatal dispositions and genetic analysis of monozygotic female twins with suprasellar cysts and hydrocephalus: A case report.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Article
  7. Article
  8. Review
  9. Medicines for headache before and during pregnancy: a retrospective cohort study (ATENA study).Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Article
  10. Review
  11. Article
  12. Article
  13. [Environmental factors of non-syndromic cleft lip and palate].Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2019
    Article
  14. Article
  15. Article
  16. Review
  17. Teratogenic Effects of Topiramate in a Zebrafish Model.International journal of molecular sciences · 2017
    Article
  18. Review
  19. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 1 institution in 2 countries.

Abdulaziz M S AlsaadThe Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON M5S 3M2, Canada; Department of Pharmacology & Toxicology, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Shahnaz Akthar ChaudhryThe Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada.
Gideon KorenThe Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON M5S 3M2, Canada. Electronic address: gkoren@sickkids.ca.
University of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Topiramate (TPM) is an increasingly used drug during childbearing ages for treatment of epilepsy, migraine, and appetite suppression as well as for off-label indications such as sleep and psychiatric disorders. Presently, while some reports suggested an increased risk of oral cleft (OC), these reports are balanced by studies that could not confirm such association. We conducted a meta-analysis of all studies reporting on women exposed to TPM during pregnancy. Of the 2327 publications reviewed, 6 articles met the inclusion criteria including 3420 patients and 1,204,981 controls. The odd ratio (OR) of OC after the first trimester exposure to TPM exposure was 6.26 (95% confidence interval: 3.13-12.51; P = 0.00001). This study provides strong evidence that TPM is associated with an increased risk of OC in infants exposed to TPM during embryogenesis and should lead to a careful review of TPM use in women of reproductive ages.

Indexed as

Prenatal Exposure Delayed EffectsAnticonvulsantsAnti-Obesity AgentsCleft PalateFemaleFructoseHumansPregnancyPregnancy Trimester, FirstRiskTopiramateAnticonvulsantsAnti-Obesity AgentsFructoseTopiramateEpilepsyInfantsOral cleftPregnancyTeratogenicityTopamaxTopiramate

Identifiers

PMID25797654
OpenAlexW2040118150

What OpenQuestion 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 OpenQuestion graph.