Evidence map›Paper›PMID 28513059›Full record

SynthesisBritish journal of clinical pharmacology2017

Fluoxetine and congenital malformations: a systematic review and meta-analysis of cohort studies.

Shan-Yan Gao, Qi-Jun Wu, Tie-Ning Zhang, Zi-Qi Shen, Cai-Xia Liu, Xin Xu, Chao Ji, Yu-Hong Zhao

Open access · bronzeAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 12 pooled it
7.2field-weighted citation impact, top 3% 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

27 citing papers in PubMed, 12 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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  20. Down syndrome.Nature reviews. Disease primers · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Shan-Yan GaoDepartment of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, China.
Qi-Jun WuDepartment of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, China.
Tie-Ning ZhangDepartment of Paediatrics, Shengjing Hospital of China Medical University, Shenyang, China.
Zi-Qi ShenDepartment of Obstetrics and Gynaecology, Shengjing Hospital of China Medical University, Shenyang, China.
Cai-Xia LiuDepartment of Obstetrics and Gynaecology, Shengjing Hospital of China Medical University, Shenyang, China.
Xin XuDepartment of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, China.
Chao JiDepartment of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, China.
Yu-Hong ZhaoDepartment of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, China.ORCID http://orcid.org/0000-0001-9208-1685
China Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the safety of fluoxetine use during pregnancy, and to better understand the relationship between maternal fluoxetine use during the first trimester and congenital malformations in infants.

methodsPubMed and Web of Science databases were systematically searched from inception to 21 March 2016. Additional studies were identified in a manual search of the reference lists. Two reviewers independently extracted data. A third reviewer checked the data. Estimates were pooled using a random-effects model to calculate the summarized relative ratios (RR) and 95% confidence intervals (CI).

resultsAmong 1918 initially identified articles, 16 cohort studies were included. The offspring of pregnant women exposed to fluoxetine during the first trimester had a statistically increased risk of major malformations (RR = 1.18, 95% CI = 1.08-1.29), cardiovascular malformations (RR = 1.36, 95% CI = 1.17-1.59), septal defects (RR = 1.38, 95% CI = 1.19-1.61), and non-septal defects (RR = 1.39, 95% CI = 1.12-1.73) with low heterogeneity in infants. There were no significant observations of other system-specific malformations in the nervous system, eye, urogenital system, digestive system, respiratory system, or musculoskeletal system, respectively. There was no indication of publication bias.

conclusionsThe results of this meta-analysis indicate maternal fluoxetine use is associated with a slightly increased risk of cardiovascular malformations in infants. Health care providers and pregnant women must weigh the risk-benefit potential of these drugs when making decisions about whether to treat with fluoxetine during pregnancy.

Indexed as

Abnormalities, Drug-InducedAntidepressive Agents, Second-GenerationDepressionFemaleFluoxetineHeart Septal DefectsHumansIncidenceInfantPregnancyPregnancy ComplicationsPregnancy Trimester, FirstPublication BiasAntidepressive Agents, Second-GenerationFluoxetineantidepressantsbirth defectscardiovasculardepressionmeta-analysis

Identifiers

PMID28513059
PMCPMC5595931
OpenAlexW2615214477

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.