FDA Advisors advise continued access to Avandia   (July 30, 2007)

The FDA Advisory Committee (AdComm for short) met today, July 30, 2007, and reviewed the safety data on rosiglitazone (Avandia). Despite dire warnings from one FDA staffer who advised pulling it from the market, the AdComm voted to allow it to remain on the market.

The FDA published draft questions that were to be proposed to the AdComm:

Do the available data support a conclusion that Avandia increases cardiac ischemic risk in type 2 diabetes mellitus?

• If yes, is there evidence that this risk is greater than other available therapies for the treatment of type 2 diabetes mellitus?
  

Does the overall risk-benefit profile of Avandia support its continued marketing in the U.S. (VOTE requested)?

• If yes, please comment on what FDA should do to maximize the risk-benefit considerations (e.g., limit to certain patients, incorporate a boxed warning....)
  

Members of the AdComm 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.

Now what?

Well, first of all, remember that this was a nonbinding recommendation to the FDA from experts, so in theory the FDA might conceivably overrule the recommendations, and yank the drug. But I expect they probably won't.

Secondly, expect to hear that GSK, the manufacturer of Avandia, will be doing more studies.

Third, expect to hear that the label will be so heavily-laden with safety statements that few physicians will start new patients on it, and will use Actos (a related drug that wasn't under such intense scrutiny today) or other classes of diabetes drugs instead.

Next, expect to see advertising everywhere on the internet, newspapers, and television from the bottom-dwelling, scum-sucking vampires called trial lawyers as they attempt to grab a honeypot of money from GSK for causing harm to so many innocent people (!).

Finally, 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).