Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Several drugs and chemotherapies seem to have an impact on the myocardium and are responsible of myocarditis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by myocarditis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
Study Type
OBSERVATIONAL
Enrollment
6,000
Drugs susceptible to induce myocarditis
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, France
Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs.
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Causality assessment of reported myocarditis events according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the myocarditis depending on the category of drug
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the other related adverse events concomitant to the myocarditis induced by drugs
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the population of patients having myocarditis adverse event
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
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Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019