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News Articles >> Avandia: Yet Another Nail in the Coffin
Avandia: Yet Another Nail in the Coffin
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| December 12, 2007. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Toronto, ON: A Canadian study, released yesterday, suggests that for every 100 people taking diabetes drug Avandia over a four-year period—five will die, four will suffer a heart attack and three more will experience heart failure.
In response, the US Food and Drug Administration (FDA) is standing pat.
The study, originating at the Institute for Clinical Evaluation Sciences in Toronto, was published December 11th in the Journal of the American Medical Association (JAMA). According to the study's lead author Dr. Lorraine L. Lipsombe, who is affiliated with the independent nonprofit group with a mandate to evaluate treatments, the drug use and health outcomes of 159,000 people aged 65 and older currently treated for Type 2 diabetes were evaluated. Of those patients, rostered with the government-run health care system in the province of Ontario 2,268 individuals were on Avandia therapy.
It has been suggested that such a retrospective observational study carries less weight than a controlled clinical trial. Nonetheless, the findings mirror the conclusions originating with Dr. Steven E. Nissen's meta analysis that was published in the New England Journal of Medicine (NEJM) last May. The latter study, which succeeded in galvanizing public opinion with regard to Avandia, suggested a 42 per cent increased risk of heart attack amongst those patients taking Avandia.
The Toronto study concludes that Avandia users had a 60 per cent increased risk for heart failure, a 40 per cent increased risk for heart attack and a 30 per cent increased risk of death, when compared with individuals taking other forms of oral diabetes medication.
Dr. Nissen, of the Cleveland Clinic, said Tuesday that this latest study could foster resolve within the FDA to further intensify the scrutiny surrounding Avandia, and motivate the agency to act.
In spite of mounting concern over Avandia the FDA has stubbornly maintained that the drug should remain on the market, but finally tagged Avandia with a black box warning for heart failure after publication of Nissen's meta-analysis study in May, and the emergence of details that revealed doubts about Avandia as far back as 1999. One of the FDA's own safety officers called for a black box warning for Avandia in the spring of 2006, but she was rebuffed by senior administration, and she eventually left the agency. The FDA ordered a second black-box warning to Avandia for risk of heart attack—a much more serious condition than heart failure—this fall.
For now, the FDA is prepared to do little else. In a statement released yesterday in response to the Toronto study, the agency stands by its earlier position that evidence against Avandia was inconclusive.
"This new study we have just seen today does not change F.D.A.'s recommendations. The information F.D.A. provided for the most recent labeling change remains accurate — the data are inconclusive and we have added a boxed warning to the labeling to ensure that health care professionals and patients are aware of this potential risk and can take this into account as they make individual prescribing decisions."
Not surprisingly, Avandia maker GlaxoSmithKline claimed that the Canadian study was flawed, in that patients within the Ontario health program were typically individuals who had not responded to other treatments, and faced a higher baseline of cardiovascular disease.
Since Avandia hit the headlines in May, sales have plummeted. Once a $3.4 billion global blockbuster, performance has faltered as doctors switch their patients to diabetes drugs that carry less risk. In recent days two major drug formularies announced that Avandia would no longer be on their rosters, and it was just revealed that Avandia is linked to osteoporosis by contributing to bone loss.
The FDA has been under the microscope within the context of its role as regulator, and its record of response where Avandia is concerned.
In view of this latest study, which on its own may be construed as a lightweight but reflects the findings of more scientific analysis, it will be interesting to see what the FDA does next.
Or doesn't...
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