Avandia Fact Released in Preparation for FDA Hearing
As I mentioned last week, there will be an FDA Advisory Committee (AdComm) meeting this week to discuss the safety of the diabetes drug Avandia (rosiglitazone). The FDA has now published background material in preparation for the meeting, which includes a list of questions that the Advisory Committee will be asked to answer. To me, the key question is the following: "Based on the available data, which of the following regulatory actions do you recommend FDA pursue regarding rosiglitazone?" The options the Advisory Committee members are given are:
"A. Allow continued marketing and revise the current label to remove the boxed warning and other warnings regarding an increased risk of ischemic CV events, or
B. Allow continued marketing and make no changes to the current label, or
C. Allow continued marketing and revise the current label to add additional warnings (e.g., contraindications for certain patient populations, recommendation for second-line use in patients intolerant of or uncontrolled on other anti-diabetic agents); or
D. Allow continued marketing, revise the current label to add additional warnings, and add additional restrictions on use (such as restricting prescribing to certain physicians or requiring special physician and patient education)
E. Withdrawal from the U.S. market."
If indeed the AdComm feels the data about Avandia's risk of heart disease is of great concern, they may well choose to vote for E: to recommend that Avandia be withdrawn from the market. I think that's a reasonable possibility, and if so, the media will be swarming all over the place with headlines that suggest "FDA to withdraw diabetes drug" (even though the FDA is not obliged to automatically follow the recommendations of their Advisory Committees, that's a short and splashy headline that's bound to occur).
So, there's an obvious question for folks who are presently taking Avandia to help control their diabetes: should I stay on it?
My answer is "yes, but..."
If you are on Avandia, have no history of heart disease or stroke, and have no risk factors such as hypertension or smoking, and if it is clear that Avandia is helping to control your glucose levels, there's no rush to change from Avandia to any other diabetes medication. Even if the Advisory Committee votes to remove the drug, the FDA will take a while for its bureaucracy to evaluate everything from the AdComm and make a final decision. Your doctor and you can decide whether to switch to the other drug in the same class as Avandia (Actos, AKA pioglitazone) or perhaps try treating your diabetes without glitazones.
If you are on Avandia, have no history of heart disease, and it is not helping to control your glucose levels, you probably should be switching to another diabetes medication or adding insulin therapy. There are numerous other oral diabetes drugs that could be tried, and insulin always works (maybe it's time for you to start insulin therapy!) - you should discuss all the options with your diabetes team.
If you are on Avandia, and have a history of heart disease or stroke, you should already have advised to switch from Avandia to another diabetes treatment. Hints about Avandia's increased risk has been out there for over two years, and there are now several studies that imply that staying on this drug is increasing your risk of more heart problems. You should talk to your physician about switching as soon as convenient - and I wouldn't wait for your next appointment if it's many months away.
Finally, if you are on Avandia, and the AdComm advises taking Avandia off the market, do not stop taking it just because of the adverse publicity. Talk things over with your diabetes team about what options you have.