FDA Avandia Hearing Update – Committee Votes to Keep Avandia on the Market but with Restrictions
The FDA advisory panel on Avandia voted in favor of keeping Avandia (rosiglitizone) on the market the vote breaks down as follows.
On the question based on available data, which of the following regulatory actions do you recommend the FDA pursue regarding of rosiglitazone?
|
|
Allow Continued Marketing and Revised Current Labeling |
Allow Continued Marketing with Changes in Label and Adding Restrictions to Use |
Allow Continued Marketing with No Changes |
Withdraw from Market |
Abstain |
|
Marketing Avandia |
7 |
10 |
3 |
12 |
1 |
If rosiglitazone remains on the U.S. market, do you recommend that the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial continue in order to provide further data on the comparative CV safety of rosiglitazone, pioglitazone and standard of care management of type II diabetes:
|
|
Continue with the Trial |
Discontinue the trial |
Abstain |
|
TIDE Trial |
20 |
10 |
2 |