Avandia (rosiglitazone) FDA Investigation

Dr. Bill Quick Health Pro
  • Avandia has come under attack again; this time, it's from the United States Congress. The majority of the report from the Senate Finance Committee is available on-line, and the full report will apparently be available soon (a link is given, but it's not working today).


    What is Avandia? Avandia (rosiglitazone) is a pill for type 2 diabetes (T2D); it is in the same class of drugs as Actos (pioglitazone). These two drugs are widely used as second-line agents to treat T2D if metformin or sulfonylureas don't do the trick of lowering A1C sufficiently. Avandia has been known to have cardiac safety issues for years.

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    According to the new Congressional report, "Committee investigators reviewed over 250,000 pages of documents provided by GSK, the FDA, the University of North Carolina, and others. Anonymous whistleblowers who contacted Senator Grassley's investigators provided hundreds of other pages. For well over a year, Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA and anonymous whistleblowers." There are some pretty damning statements in the report, such as "GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk." If you like conspiracy theories, you can learn juicy nuggets, such as the FDA internal discussions about killing the drug, and learn that  memos from GSK were written that were hidden from public view.


    Sure, but so what? Of course there would be proponents (and opponents) of removing the drug, and of course the manufacturer would have internal memos that never came to public attention. The press is now having a field day, picking on both GSK and the FDA, and I expect the trial lawyers will resume their "BAD-DRUG" advertisements.

    But the cardiac risk issues that I am reading about today, I wrote about previously. There's nothing new that I can see, except that the FDA has called for yet another Advisory Committee review of Avandia's safety. Here's what I have previously written about Avandia:

    (1) In a series of predictions for what might happen in the field of diabetes in 2009, I sarcastically predicted that "Avandia (rosiglitazone) will be voluntarily taken off the market. Avandia has had cardiac safety problems resulting in label changes and it is becoming less-and-less profitable for the manufacturer. In an unexpected fit of ethics, the manufacturer would make it clear that they consider ethics more important than satisfying their shareholders. FDA officials, newspaper editors, and financial analysts worldwide will be utterly amazed." But that didn't happen.

    (2) And more seriously, in July 2007 I wrote, in an essay titled FDA Advisors advise continued access to Avandia: "Members of the [FDA Advisory Committee] voted 22-1 in favor of keeping Avandia on the market in the U.S.; they also voted 20-3 that there is sufficient data to show that Avandia increases the risk of cardiac ischemia. Some panel members said the drug should remain on the market with restrictions, especially for patients who are also taking insulin. Some panelists said the drug's label should include a so-called "black-box" warning, the most severe the FDA can require, to clearly state that risk. Some suggested the label caution against using the drug together with insulin because doing so may elevate heart risks. The experts also asked that the drug be studied further."

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    My advice from 2007 still stands today:

    If you're taking Avandia: you've probably already spoken to your physician about whether to continue it or not. But no matter what, don't precipitously discontinue the drug because of news reports today - be sure that you and your physician agree on an alternate program (Actos or another pill, or starting insulin, or if you've been doing very well, maybe stopping the Avandia and aggressively continuing your meal plan and exercise program).

Published On: February 21, 2010