Drugs and dilated cardiomyopathies: a case/noncase study in the French PharmacoVigilance Database

Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Dilated cardiomyopathy is a frequent disease, responsible for 40–50% of cases of heart failure. • Several aetiologies have been reported: idiopathic, familial/genetic, viral and/or immune but also toxic agents (alcohol, cobalt, carbon monoxide, lead, cocaine, mercury or drugs). • Among drugs, anthracyclines are well known to induce such an adverse drug reaction. WHAT THIS STUDY ADDS • This study describes an association with already suspected drugs (anthracyclines, antiretrovirals). • It also found a signal with other drugs (antipsychotics, lithium, antidepressants, retinoids). • This pharmacovigilance signal should be confirmed by further prospective studies. AIMS To evaluate putative associations between drugs and dilated cardiomyopathy. METHODS We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. RESULTS Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were ‘suspect’. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. CONCLUSIONS The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database

“…Thus, the case/noncase method is a very useful method for assessing and detecting associations between a specific adverse drug effect and exposure to drugs in real conditions of use, because it is simple and quick and the data used are already available. Several studies have been recently published using this method on this database applying to different fields of drug safety [3,8] but also to pharmacodependence [9].…”

A Review of Pharmacoepidemiologic Studies of Antipsychotic Use in Children and Adolescents

“…Among the remaining papers, 6 were not eligible because they did not use populationbased samples, 2 papers were concerned with neurobiology and (or) pathophysiology, and 7 were pharmacovigilance reports. [10][11][12][13][14][15][16] The remaining 26 papers were concerned with topics not relevant to the review. Finally, one additional paper that was published after completion of the review was included because it reported Canadian data.…”

Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database

“…Less frequently, it could be related to some toxic agents or drugs. A case-noncase study using the French PharmacoVigilance database was able to describe an association with some already suspected drugs (such as anthracyclines and antiretrovirals), but also with other drugs (antipsychotics, lithium, antidepressants and retinoids) less known to induce such an ADR [9]. This finding represents a pharmacovigilance signal which needs to be investigated by future prospective studies.…”