Update - March 17, 2011 - Cellino & Barnes is no longer accepting new Avandia Cases.
Update - Sept. 26, 2010 -
FDA significantly restricts access to the diabetes drug Avandia
The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.
These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Update - Feb. 26, 2010
Visit FDA website
- Avandia is back in the news because of its possible link to heart problems.
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Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, released a committee report based on a two year inquiry of the diabetes drug Avandia.
The senators asked the FDA to explain what steps they have taken to protect patients in an ongoing Avandia clinical study. They further questioned why the study has been allowed to continue, considering the fact that the FDA estimates the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.
"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust," Baucus said. "We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines."
The committee report explores when GlaxoSmithKline became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.
Lawyers Helping Avandia Clients
If you or a loved one has suffered a heart injury as a result of taking Avandia, contact us online or call us at 800-621-2020.
In May 2007, the Food and Drug Administration (FDA) issued a safety alert on diabetes drug Avandia after studies found a potentially significant increased rate of heart-related deaths among patients taking the diabetes drug.
Avandia was approved in 1999 for treatment of type 2 diabetes. Since the drug was approved, FDA has monitored heart-related side effects. Some of these side effects included edema and congestive heart failure. In 2006, the most recent labeling change for Avandia for the first time added a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.
The New England Journal of Medicine reports studies showing up to a 43% increase in heart attacks and other heart problems in people using Avandia.
In November 2007, the FDA added a boxed warning to the Avandia label. The warning alerts patients and doctors that the drug may increase a patient's risk of heart attack and angina heart-related chest pain.
Patients who are taking Avandia, particularly those who have underlying heart conditions, should contact their doctor about this new information to determine the proper course of treatment.
If you have suffered an injury after taking Avandia, contact Cellino & Barnes at 1-800-621-2020 or contact us.