Avandia Overview
New Avandia Research shows link to heart attacks
Avandia maker GlaxoSmithKline now agrees to pay 460 million to resolve a majority of the pending lawsuits against the manufacturer. The lawsuits allege that Avandia can cause heart attacks and strokes.
Doctor Steven E. Nissen, a Cleveland Clinic cardiologist, did a study of more than 35,500 patients found that Avandia significantly raises the chances of a heart attack.
Avandia Increases the Risk of Heart Attack
In one of the new analysis, Nissen and a colleague pooled data from 56 studies involving 35,531 patients, including 19,509 who took Avandia. In a paper released online by the Archives of Internal Medicine, the researchers concluded the drug increased the risk for heart attacks from 28 percent to 39 percent. The pair calculated that the drug would cause one heart attack among every 37 to 52 patients who used it for five years.
The second study was a federal analysis of more than 227,500 Medicare patients and found the drug boosts the risk for strokes, heart failure and death.”There’s no reason to keep this drug on the market,” said Steven E. Nissen, a Cleveland Clinic cardiologist who conducted one of the analyses and has long criticized the drug. “This is a harmful drug.”
Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, released a committee report based on a two year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients.
Americans should know the Health Risks of Avandia
“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” Baucus said. “We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines.”Full publication at: http://finance.senate.gov/press/Gpress/2010/prg022010.pdf
The first study and overall analysis of scientific evidence released in 2007 found rosiglitazone (Avandia) increased the risk of cardiovascular disease and heart attack, which led many doctors and patients to discontinue use of the drug.
Of the diabetes patients in this new study, 89 percent were using combination therapy before discontinuing use of rosiglitazone. After discontinuation, 33 percent of patients were on combination therapy. Another 13 percent of patients weren’t prescribed any diabetes medications.
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