Avandia News
Should the FDA Require Cardiovascular Studies for Diabetes Medications?
-About.com
07/10/2008- The FDA is considering the possibility that required cardiovascular studies should be added to the approval process for diabetes drugs. There does seem to be a correlation between cardiovascular risks and diabetes medications. The meta-study on Avandia showed a possible risk of serious cardiovascular events, even though it was ultimately found to be inconclusive.
The portion of the ACCORD study which was testing the benefits of tight control of diabetes was halted due to increased cardiac related deaths.
Diabetes is a double-edged sword. When blood sugar is uncontrolled, all kinds of complications can arise, including cardiovascular complications, such as heart disease, and risk of strokes. But it also seems that some medications and therapies might also increase the risk.
The FDA says that, "conclusive evidence of a reduced risk of macrovascular complications in type 2 diabetes has not yet been established for any of the currently available antidiabetic medications, including insulin."
On the other hand, there might be enough evidence to warrant studying the cardiovascular safety of diabetes drugs.
The FDA at a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee meeting, July 1-2, 2008, stated, "Type 2 diabetes affects millions of people in the United States, causing considerable morbidity and mortality.
Cardiovascular disease accounts for most deaths among people with diabetes. Therefore, the question of cardiovascular assessment of drugs and biologics developed for the treatment of type 2 diabetes is of high public health importance."
If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Avandia's side effects, a possible Avandia class action lawsuit, or any other type of Avandia litigation.
