Alert: More Studies Point To T2 Diabetes Drug Avandia RiskTuesday, June 29, 2010
Alert: More Studies Point To T2 Diabetes Drug Avandia Risk
By Mike Boyle
Two new studies are offering strong new evidence that the widely used type 2 diabetes drug Avandia (rosiglitazone) – manufactured by GlaxoSmithKline (GSK) – increases the risk of heart problems and strokes, bringing up, again, questions about the drug`s safety.
In the first new study, which included more than 35,500 people, researchers found that Avandia significantly raised the chances of a heart attack. The second study, a federal analysis of more than 227,500 Medicare patients – and the largest such study to date - concluded that the drug boosts the risk for strokes, heart failure and death.
According to the researchers who led the analyses and several drug-safety advocates, these new research studies, released on June 28, are expected to prompt the U.S. Food and Drug Administration (FDA) to remove the drug from the market. That decision could come next month when the FDA will hold a special joint meeting of two of its advisory panels to reevaluate Avandia`s status.
Speaking to the Washington Post, Steven E. Nissen, a Cleveland Clinic cardiologist who conducted one of the analyses and has long criticized the drug, said, "There`s no reason to keep this drug on the market. This is a harmful drug."
In a statement, GSK, stood by the medication, saying, "Taken together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death." The company pointed to several other studies that have found no evidence the drug is unsafe. The studies that found no risk were better designed and therefore more reliable, the company says.
This past February a staff report from the Senate Committee on Finance questioned the Avandia`s safety and challenged both regulators and the drug maker`s behavior in handling the matter.
In their report, the senators suggested that GSK was aware of the increased cardiac risk but chose not to disclose it. Their report also showed that the FDA itself estimated the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. FDA officials have previously called the clinical trial "unethical and exploitative" of patients. However, other trial investigators see no ethical issues with the trial.
Representative Rosa DeLauro (D-Connecticut), who chairs the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, said in a June 28 statement, "Coupled with the previous findings, these new studies appear to confirm that Avandia is dangerous and should be pulled from the market. The evidence now seems to be overwhelming that taking Avandia significantly increases a patients` risk of a heart attack, even when compared to a similar prescription drug. This information will make it even more difficult for the FDA to justify keeping this dangerous drug on the market."
The American Heart Association weighed in on the rosiglitazone (generic name for Avandia) debate in a June 29 press release, saying:
" ...the reports deserves serious consideration, and patients with diabetes who are 65 years of age or older and being treated with rosiglitazone should discuss the findings with their prescribing physician. . .
"For patients with diabetes, the most serious consequences are heart disease and stroke, and the risk of suffering from them is significantly increased when diabetes is present. As in most situations, patients should not change or stop medications without consulting their healthcare provider."
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Originally posted June 29, 2010.