FDA Avandia Hearing Update – Committee Votes Increased Risk of CV events, No Increase in Mortality
After almost two days of rigorous debate, the time for the FDA vote on the fate of Avandia is upon us.
The 33 member FDA advisory committee on rosiglitizone has voted that despite causing increase risk in cardiovascular events Avandia does not increase risk of death.
On the Question of Avendia (rosiglitazone) increases risk of ischemic CV events in patients with type II diabetes:
|
|
Increases Risk |
Does Not Increase Risk |
Data Inconclusive |
|
Avandia vs other glycemic agents (non TZD’s)
|
18 |
6 |
9 |
|
CV Events Avandia vs Actos |
21 |
4 |
8 |
On the question of Avandia (rosiglitazone) increases the risk of mortality in patients with type II diabetes:
|
|
Increases Mortality |
Does Not Increase Mortality |
Data Inconclusive |
|
Avandia vs other glycemic agents (Non TZD’s)
|
0 |
20 |
12 |
|
CV Events Avandia vs Actos |
7 |
12 |
14 |
Given the lack of evidence that rosiglitizone increases the risk of cardiovascular death, it is highly unlikely that FDA advisory committee will vote in favor of pulling Avandia from the market.