FDA Warning On Diabetes Drug Rosiglitazone

There has been concerns about the safety of diabetic drugs containing rosiglitazone.

Rosiglitazone is a thiazolidinedione antidiabetic agent used in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Majority members of the advisory committee set up by the FDA found a significant cause for concern because of increase in ischemic cardiovascular events with rosiglitazone relative to pioglitazone.

In clinical trials conducted by the FDA in 2007 it was found that rosiglitazone increases the risk of myocardial infarction and  death from cardiovascular causes. Studies conducted by the FDA suggest that the use of rosiglitazone increases the risk of heart attack by 43% as compared to those not taking the same medication.

Based on this study some have noted that the FDA should give more information to the clinicians regarding the use of rosiglitazone and not impose additional restrictions on its use. Others have argued that the drug should be banned from the market.

The FDA is restricting the use of rosiglitazone by asking the sponsors of the drug to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of rosiglitazone outweigh its risks. When the REMS for rosiglitazone will be implemented, the drug will be available to patients only if they are unable to achieve glycemic control with the help of other diabetic medications. If the patients presently using rosiglitazone appear to be benefiting from it and they acknowledge that they understand the risk factors then they can continue using rosiglitazone. The FDA anticipates that implementation of REMS will significantly limit the use of rosiglitazone.

The FDA has undertaken this step on basis of the assessment of all available data on the cardiovascular ischemic risk factors of rosiglitazone.

The benefits of rosiglitazone include reduction in short-term complications of hyperglycemia. It decreases the rate of progression of retinopathy and kidney diseases. But against these benefits, there are several cardiovascular risk factors.

The only other drug in this group is pioglitazone. Certain patients with severe type 2 diabetes may not tolerate pioglitazone. In some patients the disease may not be controlled by other medications. If such patients are ready to accept the concern of cardiovascular risk factors of rosiglitazone in exchange of the benefits of glycemic control then the health care professionals can use rosiglitazone for glycemic control. Long term use of pioglitazone increases the risk of bladder cancer so some patients with a history of bladder cancer may not want to take pioglitazone for a long duration. With only two drugs available in the thiazolidinedione group certain flexibility in the usage of rosiglitazone has to be maintained.

The case of rosiglitazone suggests the need to evaluate the safety of medicines that are administered for a long term.