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20-12 Vote to Strengthen Avandia Warning, but Many Panelists Want Ban

In a recent ruling, members of an FDA advisory panel voted to require the diabetes drug, Avandia to carry more severe label warnings and perhaps require patient education. However, 12 of the panel's 33 members advised the FDA to take the drug off the market. Several other panel members said they nearly voted the same way.

Only three panelists voted to leave Avandia on the market with its current label. Many panelists who voted not to ban Avandia said they did so because of worries that a small number of patients may need the drug if other treatments fail.

Ten of the panelists want Avandia maker GlaxoSmithKline to develop patient and doctor education programs to raise awareness of the drug's risks. Avandia and Actos, the other approved drug in the same class, both increase risk of heart failure.

But there is growing but inconclusive evidence that Avandia also increases the risk of heart attack, fracture, infection, and high cholesterol.

"The evidence is much less convincing than we would like it to be ... but there is meaningful evidence of Avandia harm, and I have not heard meaningful evidence of benefit that cannot be obtained by another drug. The public would be best served by not having the drug available," said panelist Richard Platt, MD, chair of population medicine at Harvard University.

"I absolutely could not vote for withdrawal," said panelist Arthur J. Moss, MD, professor of cardiology at the University of Rochester, N.Y. "I wanted to send a message to the FDA because a proper trial should have been done in 1993 when they first had an investigational new drug application [for Avandia], and that trial still needs to be done.

Panelists Want Ban

The panel also voted 19-11 to continue with a clinical trial, nicknamed TIDE, comparing Avandia to Actos. Critics of the study say the trial is unethical, as it is basically asking patients to take Avandia to see if it harms them. But most panelists, frustrated by two days of inconclusive study presentations, want to see some answers -- even if it takes years.

Oddly, panel members who voted to ban Avandia voted to continue the TIDE trial. One such panelist was Marvin Konstam, MD, professor of cardiology at Tufts University, Boston.

"The panel vote was to leave the drug on the market, and so we will need this study," Konstam said. "You need to inform the patient enrolled in the trial that the only reason Avandia is in the study is to see if it harms you. That is a problem." ۞

Are you taking this drug? Be informed about the dangers to your health.

Be sure to listen to Dr. David C. Kolbaba's "rant" about Avandia in our HealthQuest Radio broadcast, "Dr. K Has An Anger Issue". According to a February 2010 Senate report, 83,000 heart attacks occurred in an 8 year period due to use of this prescription drug. Dr. K addresses the debate over this controversial diabetes medication and its health ramifications such as damage, toxicity and death. Visit our Hot Topics section under Breaking News for our commentary regarding the Senate Report on Avandia.

With over 28 years of clinical experience, Dr. Kolbaba can help bring you to higher health and longevity. Visit "Our Office for more information about our HealthQuest Clinic. Connect with us by calling our HealthQuest Radio Hotline at 1-800-794-1855 anytime.

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