Safety data from controlled clinical trials has shown a significant increase in the risk of heart attack and heart-related deaths in patients that are taking Avandia (rosiglitazone) for type 2 diabetes.
However, there is other published and non published data from long term clinical trials that contradict the evidence about the risk of heart attack in patients currently taking Avandia.
While the FDA is not recommending patients stop taking Avandia, they are suggesting they contact their doctor to discuss their current treatment.
The FDA is unsure whether the other approved medications in the same class for treating type 2 diabetes has less, the same or even greater risks. Switching to other therapies also confers its own risks. For this reason, the FDA is providing this safety alert to prescribers so they can make informed treatment decisions.