Evidence map›Paper›PMID 28831528›Full record

ArticleEuropean journal of clinical pharmacology2017

Association between infection and severe drug adverse reactions: an analysis using data from the Japanese Adverse Drug Event Report database.

Takuya Imatoh, Kimie Sai, Chisato Fukazawa, Yasushi Hinomura, Ryosuke Nakamura, Yoshimi Okamoto-Uchida, Katsunori Segawa, Yoshiro Saito

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Article in European 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

  1. Review
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4 · The record

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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

8 authors.

Takuya ImatohDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan. imatoh@nihs.go.jp.ORCID http://orcid.org/0000-0002-8160-7335
Kimie SaiDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
Chisato FukazawaJapan Pharmaceutical Information Center, Shibuya 2-12-15, Shibuya-ku, Tokyo, 150-0002, Japan.
Yasushi HinomuraJapan Pharmaceutical Information Center, Shibuya 2-12-15, Shibuya-ku, Tokyo, 150-0002, Japan.
Ryosuke NakamuraDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
Yoshimi Okamoto-UchidaDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
Katsunori SegawaDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.
Yoshiro SaitoDivision of Medicinal Safety Science, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, Tokyo, 158-8501, Japan.

Funding

Japan Society for the Promotion of Science 16K08433
6 · The paper itself

Abstract

purposeIt has been reported recently that immune reactions are involved in the pathogenesis of certain types of adverse drug reactions (ADRs). We aimed to determine the associations between infections and drug-induced interstitial lung disease (DILD), rhabdomyolysis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), or drug-induced liver injury (DILI) using a spontaneous adverse drug event reporting database in Japan.

methodsThe reported cases were classified into three categories (anti-infectious drug group, concomitant infection group, and non-infection group) based on the presence of anti-infectious drugs (either as primary suspected drug or concomitant drug) and infectious disease. We assessed the association between four severe ADRs and the presence and seriousness of infection using logistic regression analysis.

resultsWe identified 177,649 cases reported in the study period (2009-2013). Logistic regression analysis showed significant positive associations between infection status and onset of SJS/TEN or DILI (SJS/TEN: anti-infectious drug group: odds ratio (OR) 2.04, 95% CI [1.85-2.24], concomitant infection group: OR 2.44, 95% CI [2.21-2.69], DILI: anti-infectious drug group: OR 1.27, 95% CI [1.09-1.49], concomitant infection group: OR 1.25, 95% CI [1.04-1.49]), compared to the non-infection group. By contrast, there were negative or no associations between infection and DILD or rhabdomyolysis. A significantly positive association between infection and SJS/TEN seriousness (OR 1.48, 95% CI [1.10-1.98]) was observed.

conclusionsThis study suggested that infection plays an important role in the development of SJS/TEN and DILI. For the patients with infection and/ or anti-infectious drugs, careful monitoring for severe ADRs, especially SJS/TEN, might be needed.

Indexed as

Databases, FactualDrug-Related Side Effects and Adverse ReactionsHumansInfectionsJapanDrug-induced interstitial lung diseaseDrug-induced liver injuryInfectionRhabdomyolysisStevens-Johnson syndromeToxic epidermal necrolysis

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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.