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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myocarditis induced by drugs and chemotherapies | Case reported in the World Health Organization (WHO) of myocarditis of patient treated by a drug, with a chronology compatible with the drug toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug inducing myocarditis | Drug | Drugs susceptible to induce myocarditis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs. | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Causality assessment of reported myocarditis events according to the WHO system | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 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) | 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 | 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 | 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 | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 |