Systematic analysis of drug-associated myocarditis reported in the World Health Organization pharmacovigilance database
Lee S. Nguyen (),
Leslie T. Cooper,
Mathieu Kerneis,
Christian Funck-Brentano,
Johanne Silvain,
Nicolas Brechot,
Guillaume Hekimian,
Enrico Ammirati,
Badr M’Barek,
Alban Redheuil,
Estelle Gandjbakhch,
Kevin Bihan,
Bénédicte Lebrun-Vignes,
Stephane Ederhy,
Charles Dolladille,
Javid J. Moslehi and
Joe-Elie Salem ()
Additional contact information
Lee S. Nguyen: CMC Ambroise Paré, Research & Innovation (RICAP)
Leslie T. Cooper: Mayo Clinic
Mathieu Kerneis: Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166
Christian Funck-Brentano: Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital
Johanne Silvain: Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166
Nicolas Brechot: AP-HP, Sorbonne Université, Pitié-Salpêtrière
Guillaume Hekimian: AP-HP, Sorbonne Université, Pitié-Salpêtrière
Enrico Ammirati: Niguarda Hospital
Badr M’Barek: CMC Ambroise Paré, Research & Innovation (RICAP)
Alban Redheuil: AP-HP, Sorbonne Université, Pitié-Salpêtrière
Estelle Gandjbakhch: Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166
Kevin Bihan: Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital
Bénédicte Lebrun-Vignes: Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital
Stephane Ederhy: AP-HP, Sorbonne Université, Pitié-Salpêtrière
Charles Dolladille: CHU de Caen
Javid J. Moslehi: Vanderbilt University Medical Center
Joe-Elie Salem: Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital
Nature Communications, 2022, vol. 13, issue 1, 1-10
Abstract:
Abstract While multiple pharmacological drugs have been associated with myocarditis, temporal trends and overall mortality have not been reported. Here we report the spectrum and main features of 5108 reports of drug-induced myocarditis, in a worldwide pharmacovigilance analysis, comprising more than 21 million individual-case-safety reports from 1967 to 2020. Significant association between myocarditis and a suspected drug is assessed using disproportionality analyses, which use Bayesian information component estimates. Overall, we identify 62 drugs associated with myocarditis, 41 of which are categorized into 5 main pharmacological classes: antipsychotics (n = 3108 reports), salicylates (n = 340), antineoplastic-cytotoxics (n = 190), antineoplastic-immunotherapies (n = 538), and vaccines (n = 790). Thirty-eight (61.3%) drugs were not previously reported associated with myocarditis. Antipsychotic was the first (1979) and most reported class (n = 3018). In 2019, the two most reported classes were antipsychotics (54.7%) and immunotherapies (29.5%). Time-to-onset between treatment start and myocarditis is 15 [interquartile range: 10; 23] days. Subsequent mortality is 10.3% and differs between drug classes with immunotherapies the highest, 32.5% and salicylates the lowest, 2.6%. These elements highlight the diversity of presentations of myocarditis depending on drug class, and show the emerging role of antineoplastic drugs in the field of drug-induced myocarditis.
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-021-27631-8
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DOI: 10.1038/s41467-021-27631-8
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