Avandia (rosiglitazone), which is used to treat type 2 diabetes, has already been banned in Europe. It is still available in the United States, but continues to sink in reliability as it is associated with high risk of serious heart ailments including congestive heart failure, heart attack and death compared with a similar drug also used to combat diabetes, pioglitazone (Actos).
Both drugs are thiazolidinediones, first introduced in the late 1990s, that help to control blood sugar levels in patients with type 2 diabetes.
Update June 7th 2013 – On June 6th, 2013, an FDA advisory panel voted to loosen the restrictions on Avandia (rosiglitazone), which have been in force since 2010.
In 2010, the European Medicines Agency suspended the use of rosiglitazone, but in the United States it is still available on a restricted basis. Therefore, a team of researchers in the UK set out to compare the cardiovascular effects of the two drugs among patients with type 2 diabetes. Both drugs attribute to increase heart problem risk, but how much?
The study’s authors conclude:
“Our findings have important implications. Rosiglitazone is still available on a restricted basis in the United States and Canada. However, for patients who need thiazolidinedione treatment, continued use of rosiglitazone may lead to excess heart attacks, heart failure and mortality, compared with pioglitazone.”
Given that there are about 3.8 million prescriptions for rosiglitazone dispensed annually in the United States, the effect on public health may be considerable. Compared with pioglitazone, rosiglitazone was associated with a significant increased risk of heart attack (16%), congestive heart failure (23%), and mortality (14%).
Victor Montori and Nilay Shah from the Mayo Clinic adds:
“The rosiglitazone story says much about how healthcare has become less about promoting patients’ interests, alleviating illness, promoting function and independence, and curing disease, and much more about promoting other interests, including those of the drug industry.”
Back in September of 2010, Diabetes UK announced:
“People currently taking all forms of the recently suspended drug Avandia (Rosiglitazone) have until 21 October to be reviewed and transferred onto an alternative treatment.”
In New Zealand, rosiglitazone was to be withdrawn from the market before April 29, 2011 after concern about its make an elevated risk of cardiovascular events.
On July 30, 2007 an Advisory Committee of the Food and Drug Administration concluded the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events (including heart attacks) than a placebo, but data from several long term, prospective clinical trials showed when rosiglitazone was compared to metformin, or sulfonylurea, there was no difference in the risk of heart attack.
These data, coupled with the meta-analysis, prompted the FDA to state the data on the association between rosiglitazone and myocardial ischemia were inconclusive. The meta-analysis was not supported by an interim analysis of the trial designed to evaluate this, and several other reports have failed to conclude the controversy.
On July 19, 2010 the nonprofit group Physicians Committee for Responsible Medicine (PCRM) announced they were suing the FDA for failing to notify patients of dietary substitutes for diabetes drugs. The lawsuit, filed in the U.S. District Court for the District of Columbia, is currently underway.
A team from the Duke Clinical Research Institute (DCRI) reported in the American Heart Journal (June 2013) that Avandia is not linked to a higher heart attack risk compared to metformin/sulfonylurea. The DCRI team re-assessed the original findings of RECORD.
Written by Sy Kraft, B.A.