Canada's Adverse Drug Reaction Database uses data collected from 1965, and contains information from all adverse drug reaction (ADR) reports currently held in Health Canada's CADRIS database. For more on the database, and how CBC News acquired it, go to Canada's Adverse Drug Reaction Database.

CBC News Online ran two queries through the database related to statins. The first — the pie chart and table immediately below — was for reported deaths where a statin was suspected to cause the adverse drug reaction. The second query was for reported serious adverse drug reactions in which a statin was suspected.

Please note that the figures represent reported adverse drug reactions. It does not mean there is a direct causal link. One must also consider that drugs have been on the market for different lengths of time. As well, one must consider that patients may be on numerous medications and have varying degrees of illness.

For further details on the reported adverse reactions behind the figures below, such as dose duration and other drugs involved, use Canada's Adverse Drug Reaction Database.

In addition, Health Canada says "a greater number of reports associated with any one drug should not be interpreted as necessarily indicative of a greater safety risk of one drug over another. A valid comprehensive assessment of drug adverse event reports by Health Canada requires a full scientific analysis."

Disclaimer: This information is intended solely to give the reader convenient access to drug information compiled by Health Canada. It should be read subject to Health Canada's Caveats and Limitations (set out below). It is not a substitute for professional medical advice. If you have a medical concern, consult a qualified health professional.

Reported deaths where statin was reported as contributory

Drug name	Count of report Id
LIPITOR	24
ZOCOR	6
BAYCOL	6
PRAVACHOL	2
MEVACOR	2
LESCOL	2
SIMVASTATIN	1
LOVASTATIN	1
CERIVASTATIN	1
APO-LOVASTATIN	1
TOTAL	46
Source: Canadian Adverse Drug Reaction Information System database from Health Canada

Query Two

Reported ADRs where statin was expected

Drug name	Count of report Id
LIPITOR	535
BAYCOL	178
ZOCOR	124
MEVACOR	61
PRAVACHOL	53
CRESTOR	45
LESCOL	20
SIMVASTATIN	20
PRAVASTATIN SODIUM	14
CERIVASTATIN	12
GEN-SIMVASTATIN	8
APO-LOVASTATIN	7
LOVASTATIN	7
APO-SIMVASTATIN	4
LIN-PRAVASTATIN	4
APO-PRAVASTATIN	3
TOTAL	1095
Source: Canadian Adverse Drug Reaction Information System database from Health Canada Note: While there the query returned a total of 1095 statins reported, there were a total of 1082 unique incidents. Several incidents involved more than one statin.

Health Canada's caveats and limitations

Health Canada's Caveats And Limitations: Please note that there may be reports that have been received but not yet processed and entered into the database. New or additional information may be available at a later date.

The Canadian Adverse Drug Reaction Monitoring Programme (CADRMP) maintains a database of suspected adverse reactions to marketed therapeutic products reported to the program directly by health care professionals, consumers or through the pharmaceutical manufacturer. The CADRMP database only contains reports of reactions that have occurred in Canada with Canadian marketed products. Any information related to the reporter and patient identifiers is kept confidential as per 19(1) of the Access to Information Act.

The caveat below applies to all information provided by the Marketed Health Products Safety Effectiveness and Information Division. This caveat appears at the bottom of each page of the search request [in the Canadian Adverse Drug Reaction Information System] to assist with interpretation of the data.

CAVEAT: The vast majority of reports on which this summary is based are submitted by health practitioners and to a lesser extent laypersons. Each report represents the suspicion, opinion or observation of the individual reporter. Cause and effect relationships have not been established in the vast majority of reports submitted. The information contained in these reports to the Health Products & Food Branch is raw information and has not been scientifically or otherwise verified as to cause and effect relationship by Health Products & Food Branch scientists. Only a small proportion of suspected adverse reactions are reported to the program, consequently this information must not be used to estimate the incidence of adverse reactions. Reports submitted by Market Authorization Holders are included in this summary.

A serious adverse drug reaction is defined as: A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above, may also be considered serious.

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