Cause Mapping is a Root Cause Analysis method that captures basic cause-and-effect relationships supported with evidence.
Increased risk of heart attacks, stroke death
Two thirds of diabetics die of heart problems;
Masked test results increase risk of heart disease
Problem Solving • Incident Investigation • Root Cause Analysis
Drug originally licensed with warning about risks for patients with heart failure
Making medical decisions is difficult - even with all the information. When information about health risks determined during clinical trials is kept from the public,
Rosiglitazone (found in Avandia, Avandamet
Second-line treatment for Type 2 Diabetes
"Patients trust drug companies with their health and their lives."
-Senator Max Baucus
Impact to the Goals
Increased occurrence of heart attack, stroke,
Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did
not have success with front line treatments in 1999, studies have shown that users of this drug
(included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart
disease in users. This is of particular concern because most Type 2 diabetics die from heart
Reduced sales ($2.5 billion in 2006, <$408
disease. It is estimated that 60,000 to 200,000 people have suffered from heart disease due to
A black box warning was placed on these drugs, but not until November 2007. The European
Property, Equip, Mtls
Medicines Agency recommended that the drug be suspended from European markets in 2010,
and the drug was withdrawn from New Zealand markets in 2011. What took so long?
The patient safety goal is impacted because of the increased occurrence of stroke,
Heart problems in 66,000 to 200,000 people (One person suffers heart problems for every
heart attack, and death. The compliance goal is impacted because - according the
Senate Finance Committee - trial results that would have indicated the increased
FDA approves Avandia for controlling diabetes
risk for cardiovascular disease were not publicly released in a timely manner.
Manufacturer study reveals heart problems
Reduced sales as a result of the risk are estimated to be more than $2 billion (an
impact to the organizational goal) and lawsuits (an impact to the patient services
Manufacturer releases meta-analysis to the FDA
- Add detail as information becomes available.
goal) are projected to cost more than $1 billion.
Lancet study shoes Avandia can prevent diabetesNew England Journal of Medicine publishes analysis
Although the actual mechanism that is causing the increased risk of cardiovascular
showing drug increases risk of heart attacks by 43%
disease is unknown, the cause of the increased occurrence of heart attack, stroke
and death is due to the prescribing of the drug rosiglitazone. Although rosiglitazone
NEJM publishes study by manufacturer showing drug does
has been found to be an effective second-line treatment for Type 2 diabetes, it is
unlikely that doctors would have prescribed it as readily had they known about the
increased risk of heart disease. Instead, they were likely swayed by a multi-million
House of Representatives meets to consider whether the
dollar advertising campaign, while test results that showed increased cardiovascular
FDA should continue to allow Avandia to be sold
FDA advisory committee concludes increased risk of heart
disease but that drug should remain on market
Black box warning placed on drug at request of FDA
British Medical Journal study released discussing adverse
Senate Finance Committee accuses manufacturer of holding
Studies in Journal of the American Medical Association and
Archives of Internal Medicine show that drug increases risk
FDA convenes another advisory committee meeting vote
Senate Finance Committee releases findings that
manufacturer failed to publish studies that found serious health risks in a timely manner
European Medicines Agency recommended that the drug be
Drug withdrawn from New Zealand market after Medsafe
concluded that the risks outweigh the benefits
Avandia may only be sold with a prescription from a certified
doctor through mail order to specified pharmacies in U.S.
For a free copy of our Root Cause Analysis Template in
Microsoft Excel, used to create this page, visit our web site.
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FILE: Trauma Handbook/ stress ulcer prophylaxis UCSD MEDICAL CENTER ADULT AND PEDIATRIC GUIDELINES FOR USE OF STRESS ULCER PROPHYLAXIS* *Developed by the Stress Ulcer Prophylaxis Process Action Team Based on clinical studies, the indications for stress ulcer prophylaxis will be graded according to the following scale: Convincing evidence, indicated Some evidence, probably ind