Avandia-Is It A Killer?
The FDA recently issued a statement that says, for now rosiglitazone (Avandia) is staying on the market. When the results of the studies are completed, most likely some time later this year, they will be made public. News reports disclosed a confidential report on rosiglitazone being investigated by a U.S. Senate committee. According to a NY Times report, rosiglitazone has been linked to 304 deaths in just the third quarter of 2009 alone.
A study released by the New England Journal of Medicine as far back as 3 years ago linked Avandia, to an increased risk of heart disease. Well respected Dr. Steven Nissen, of the Cleveland Clinic, was lead author of the study. At the time of the study rosiglitazone was one of the most frequently prescribed diabetes drugs. The United States Food and Drug Administration reported to the public the possible association between rosiglitazone and increased cardiovascular risk in 2007, in safety alert 1. The FDA also sought advice from impartial experts at the July 30th, 2007 joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety as well as the Risk Management Advisory Committees.
Avandia is manufactured by the British pharmaceutical giant Glaxo Smith Kline with annual sales of approx $2.5 billion in sales before the reports of adverse effects became public, sales have since declined.
The Journal Questions Rationale Of Rosiglitazone
Although the results of Nissen’s study were troubling, they were also convincing enough for the New England Journal of Medicine, in an accompanying editorial, to conclude that “the rationale for prescribing rosiglitazone at this time is unclear.” The editorial made it clear that the cardiovascular risks outweighed any benefits of the drugs in the treatment of diabetes.
When an individual has type 2 diabetes their body does not respond correctly to naturally produced insulin. Because of the type 2 diabetes, they develop resistance to insulin. Fat, liver and muscle cells do not respond as they do in someone without the disease. The disease prevents sugar from entering the cells and being stored as energy. When sugar cannot enter the cells correctly, it builds up in the blood and causes a condition called hyperglycemia.
Type 2 Diabetes-1.5 Million New Cases A Year
More than 1.5 million new cases of type 2 diabetes are diagnosed each year in the U.S. alone. Avandia is one of the most prescribed treatments for type 2diabetes with over 60 million prescriptions written since 1999.
Rosiglitazone(Avandia) is an anti-diabetic drug, it is an insulin sensitizer, it binds to receptors in fat cells and makes the cells more receptive to insulin. In a quote from the FDA’s announcement, the “FDA recommends that healthcare professionals follow the recommendations on the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop.”
Contact A Personal Injury Attorney
The recent study represents the only new information from a completed randomized, controlled clinical trial of rosiglitazone that has been received by the FDA since 2007.
If you or a loved one has suffered adversely after taking Anandia, Avandamet, or Avandaryl, you don’t have to suffer any longer, contact a personal injury attorney at The Law Offices of Nadrich & Cohen, we can help you.