Posted: 07-08-10 Categories:
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Avandia safety risks FDA staff report, data to be released July 9, 2010

The FDA’s staff report on Avandia and supporting data will be made public tomorrow. An Avandia recall may not be far behind.

An FDA staff report on Avandia safety risks is expected to be released tomorrow.  The future of the diabetes drug hangs in the balance.   Critics claim Avandia heart risks outweigh its benefits and long have demanded an Avandia recall.  Several scientific studies, including two released last week, have linked the drug to higher heart risks than other diabetes drugs.

GlaxoSmithKline defends its blockbuster drug.  Worldwide sales of Avandia last year totaled about $800 million.  Glaxo claims its drug is safe.

“Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia, and together they show that this medicine does not increase the overall risk of heart attack, stroke or death,” said GSK vice president for clinical development, Murray Stewart.  “We also know that Avandia lowers glucose levels in both the short- and long-term and is the only oral anti-diabetic medicine that has been shown to sustain blood-sugar control for up to five years.”

Dr. Steven Nissen disagrees.   “There are no unique benefits for this drug that are not provided by other diabetes medications,” he said.  “I want the FDA to order the company to withdraw the drug. The evidence is there, and it’s been there a long time. It’s a matter of having the political will to do it.”

In 2007, the highly respected Cleveland Clinic heart expert published his analysis of the Avandia research data from clinical trials involving 35,000 diabetes patients.  Dr. Nissen concluded that, in addition to increasing the risk of heart failure, Avandia increased the risk of heart attack by 43%.

Last week, a review of 227,000 Medicare patients was published.  It found that the use of Avandia increases the risk of heart attack and stroke by 17%.

The Food and Drug Administration’s staff report and supporting data will be released to the pubic as part of the FDA’s reconsideration of Avandia’s safety and efficacy.  The report and data are being used by a FDA advisory panel meeting scheduled for July 13th and 14th.   The FDA advisory committee will meet to evaluate the cardiovascular safety of Avandia and research linking the drug to increased risks of heart attack, stroke and congestive heart failure.

The FDA advisory panel may vote to recommend an Avandia recall, a new or revised warning label, a voluntary withdrawal from the market, or no new FDA action at all.  The recommendation of the committee usually is followed by the FDA.

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