Evidence map›Paper›PMID 35354621›Full record

ArticleBMJ open2022

Nervous system drugs taken by future fathers and birth defects in offspring: a prospective registry-based cohort study.

Maarten Wensink, Ying Lu, Lu Tian, Tina Kold Jensen, Niels Erik Skakkebæk, Rune Lindahl-Jacobsen, Michael Eisenberg

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.7field-weighted citation impact, top 11% 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

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Managing anxiety-related disorders from pregnancy to parenthood.Archives of gynecology and obstetrics · 2026
    Review
  2. Article
  3. Review
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

7 authors at 3 institutions in 2 countries.

Maarten WensinkDepartment of Epidemiology, Biostatistics and Biodemography, University of Southern Denmark, Odense, Denmark mwensink@health.sdu.dk.ORCID 0000-0001-6518-1015
Ying LuDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Lu TianDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Tina Kold JensenDepartment of Environmental Medicine, University of Southern Denmark, Odense, Denmark.
Niels Erik SkakkebækDepartment of Growth and Reproduction, Juliane Marie Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Rune Lindahl-JacobsenDepartment of Epidemiology, Biostatistics and Biodemography, University of Southern Denmark, Odense, Denmark.
Michael EisenbergMale Reproductive Medicine and Surgery, Department of Urology, Stanford University School of Medicine, Stanford, California, USA.
Stanford University · USUniversity of Southern Denmark · DKCopenhagen University Hospital · DK

Funding

Paternal medications and congenital malformations in offspringR21HD096468 · NICHD · STANFORD UNIVERSITY · PI EISENBERG, MICHAEL L · 2018 to 2019
$386k
NICHD NIH HHS R21 HD096468
6 · The paper itself

Abstract

objectivesTo evaluate the association of paternal intake of antipsychotics, anxiolytics, hypnotics and sedatives, antidepressants, selective serotonin reuptake inhibitors (SSRIs) and (benzo)diazepines during the development of fertilising sperm with birth defects in offspring.

designProspective registry-based cohort study.

settingTotal Danish birth cohort 1997-2016 using Danish national registries.

participantsAll 1 201 119 Danish liveborn singletons born 1997-2016 were eligible, 39 803 (3.3%) of whom had at least one major birth defect. EXPOSURE: Offspring were considered exposed if their father had filled at least one prescription in the relevant drug category during development of fertilising sperm (the 3 months prior to conception). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was the diagnosis, in the first year of life, of at least one major birth defect as categorised in the EUROCAT guidelines. Secondary outcome was the diagnosis, in the first year of life, of at least one major birth defect in any of the EUROCAT subcategories. Adjusted ORs (AORs) were calculated, along with their 95% CIs, adjusted for year, education, smoking status and age of the mother, and education, disposable income and age of the father.

resultsThis study found weak or null associations between birth defects and selected drugs. Specifically, antidepressants (17 827 exposed births) gave 3.5% birth defects (AOR 0.97 (0.89 to 1.05)). Diazepines, oxazepines, thiazepines and oxepines (as antipsychotics, 1633 offspring) gave 4.7% birth defects (AOR 1.22 (0.97 to 1.54)), attenuated to 1.13 when excluding by mothers' prescriptions. The study was well powered assuming 100% therapy adherence, while assuming 50% therapy adherence, the study remained well powered for the largest groups (SSRIs and antidepressants overall).

conclusionsAntipsychotics, anxiolytics, hypnotics and sedatives, antidepressants, SSRIs and benzodiazepine-derived anxiolytics, when taken by the father during development of fertilising sperm, are generally safe with regard to birth defects.

Indexed as

FathersSelective Serotonin Reuptake InhibitorsCohort StudiesFemaleHumansMaleNervous SystemRegistriesSelective Serotonin Reuptake Inhibitorsepidemiologyneurologypreventive medicinepublic healthreproductive medicine

Identifiers

PMID35354621
PMCPMC8968542
OpenAlexW4220880420

What OpenQuestion holds

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LicenceCC BY-NC
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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.