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News Articles >> August Issue of Diabetes Care Documents ..
August Issue of Diabetes Care Documents Avandia Risks: Critics Assail FDA Panel
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| August 1, 2007. By Anne Borden |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Indianapolis, IN: Yet another study has associated heart problems with the diabetes drug Avandia. The study, published in the August edition of the clinical journal Diabetes Care, comes hot on the heels of a scandal at the FDA over a July 30 decision to allow the controversial drug to stay on the market.
1 out of 50 Users May Be at Risk
For the new study, researchers analyzed more than 78,000 patients taking Avandia and a similar diabetes drug (Actos). Based on their findings, the researchers estimate that a staggering one in 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure.
"This means that the diabetes drugs could cause thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services," said Yoon Loke, a clinical pharmacologist at UEA's School of Medicine, Health Policy and Practice, as reported in PharmaTimes.
Sonal Singh of Wake Forest University, who also co-authored the Diabetes Care study, expressed his concern for future patients: "These drugs are taken by more than seven million diabetic patients in the US alone, suggesting that several thousand could be harmed," he said.
Risk Factors: Surprising Results
The study's authors also reviewed 200 case studies of patients with heart failure related to the drugs, to determine risk factors. They found that typical risk factors - high dosage, poor cardiovascular health and advanced age - were not the sole determinants of risk.
For example, researchers found that the heart problems developed even in patients taking low doses, and that around 25 percent of cases occurred in people under the age of 60 without a history of cardiovascular disease.
"Most patients in the studies did not have heart failure prior to starting on treatment with these drugs," said Loke. "There doesn't seem to be a group of patients who are safe from these side effects." Based on the group's findings, Loke advises federal health agencies to "re-evaluate" their decision to recommend the drugs.
FDA Panel: Flouting the Hippocratic Oath?
A US Food and Drug Administration (FDA) advisory committee voted yesterday 22 to 1 to allow Avandia to remain on the market.
Yet, in a 20-3 vote, that same panel agreed that Avandia was tied to "increased ischemic risk" such as heart attacks. While some panel members suggested a strong "black box" warning on Avandia, they stopped short of a definitive rejection of the drug.
"Congress is looking into allegations of conflict-of-interest at the FDA," notes a longtime healthcare advocate. "Situations like this just demonstrate why it's time for an overhaul of the review process [at the FDA]."
But the controversy is perhaps best summed by the outrage of a widow, who told Pharmalot yesterday that in her opinion the panel engaged in "sophomoric political games of debating a drug that should have been adequately studied before it was brought to market.
"Why don't you [doctors] get out of your sandboxes and follow your oath to do no harm?"
Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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