Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.
OBJECTIVE
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.
Centre Hospitalier Universitaire, Poitiers, France.
Guillaume
G
Montastruc
Sylvie
S
Favreliere
Agnès
A
Sommet
Atul
A
Pathak
Maryse
M
Lapeyre-Mestre
Marie-Christine
MC
Perault-Pochat
Jean-Louis
JL
Montastruc
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D018943:Anthracyclines / Q000009:adverse effects; D002311:Cardiomyopathy, Dilated / Q000139:chemically induced*; D016208:Databases, Factual / Q000706:statistics & numerical data; D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017891:Pharmacoepidemiology; D055815:Young Adult
D018943:Anthracyclines