Avandia and Cardiomyopathy

This page shows results related to Avandia and Cardiomyopathy from the FDA Adverse Event Reporting System (AERS).

Adverse Event

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Avandia and Cardiomyopathy

Age

>60 Years	215
50-59 Years	172
40-49 Years	95
30-39 Years	16
20-29 Years	2

Gender

Male: 63%
Female: 36%
Gender Unknown: 1%

Outcome

What were the most common outcomes of those reporting Cardiomyopathy?

Hospitalization	619
Death	132
Other	63
Disability	27
Life Threatening	6

Reporter

Who most commonly reported Cardiomyopathy?

Consumer	244
Other	177
Lawyer	114
Pharmacist	89
Physician	76

Therapy

Of those reporting Cardiomyopathy, why were they taking Avandia?

Diabetes Mellitus	334
Type 2 Diabetes Mellitus	84
Drug Use For Unknown Indication	10
Type 1 Diabetes Mellitus	1

Other Medications

Which medications reported to the FDA are most commonly associated with Cardiomyopathy?

Vioxx	881
Avandia	681
Digoxin	545
Zometa	462
Aredia	281
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Clozaril	226
Fosamax	217
Cyclophosphamide	205
Avandamet	168
Remicade	154
Herceptin	153
Avonex	148
Fluorouracil	132
Humira	107
Seroquel	103
Clozapine	99
Heparin Sodium Injection	97
Dianeal	95
Avastin	95
Doxorubicin Hcl	94
Enbrel	87
Novantrone	86
Velcade	82
Adriamycin Pfs	76
Epirubicin	75
Bevacizumab	73
Gleevec	72
Etoposide	66
Desoxyn	62
Revlimid	60
Crestor	58
Celebrex	56
Dexamethasone	55
Zyprexa	55
Rebif	54
Methotrexate	50
Rituximab	49
Betaseron	48
Sutent	48
Nplate	47
Combivir	47
Forteo	46
Lipitor	44
Cytarabine	43
Docetaxel	43
Carboplatin	42
Risperdal	42
Paclitaxel	42
Exjade	42
Cymbalta	42
Fabrazyme	41

Is the adverse drug reaction you’re experiencing actually due to the drug you took?

The Naranjo Scale is a questionnaire for determining the likelihood of whether an adverse drug reaction is actually due to the drug or caused by other factors. Probability is assigned via a score termed definite, probable, possible or doubtful.^*

	YES	NO	UNKOWN
Are there previous conclusive reports on this reaction?
Did the adverse event appear after the suspected drug was administered?
Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?
Did the adverse reaction reappear when the drug was readministered?
Are there alternative causes (other than the drug) that could on their own have caused the reaction?
Did the reaction reappear when a placebo was given?
Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?
Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?
Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
Was the adverse event confirmed by any objective evidence?

Probability of an Adverse Event

Doubtful

Possible

Probable

Definite

^*Naranjo, et al. "A method for estimating the probability of adverse drug reactions." Clin Pharmacol Ther. 1981 Aug;30(2):239-45.

To learn more about all adverse events for Avandia, view the complete Avandia adverse event report.

Scientific Publications on Cardiomyopathy

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