Avandia lawyers at Motley Rice actively litigated Avandia lawsuits involving individuals with diabetes who may have suffered a heart attack, ischemic stroke or other cardiac condition while taking the drug.
Avandia® is used to treat patients suffering from type 2 diabetes, also referred to as adult onset diabetes. Manufactured by GlaxoSmithKline, Avandia is a member of a relatively new class of diabetes medication called thiazolidinediones. Because Avandia may increase the risk of heart attack, the majority of a federal medical advisory panel recommended on Wednesday, July 14, 2010, that the FDA should either withdraw Avandia from the market or severely restrict sales.
Contact an Avandia Lawyer
Motley Rice is no longer accepting Avandia cases. If you have questions about the Avandia Litigation, contact Avandia lawyers Kimberly Barone Baden by email or by calling 1.800.768.4026. Motley Rice member attorney Fred Thompson is also a member of the Avandia litigation Plaintiffs' Steering Committee.
Avandia Side Effects
Avandia, like other thiazolidinediones, can cause fluid retention which may lead to heart failure. Potential Avandia side effects can include:
- congestive heart failure or heart damage
- heart blockages or cardiovascular ischemia
- heart attack
- hemorrhagic stroke
- ischemic stroke
- sudden cardiac death
Avandia History and Potential Dangers
Avandia seeks to treat type 2 diabetes by decreasing insulin resistance to help the body control its blood sugar level, thus decreasing the body's need for additional insulin. Thiazolidinediones, including Avandia, have been linked to liver and cardiovascular complications.
Avandia was approved by the FDA and introduced to the U.S. market on April 4, 2000. Current Avandia labels warn of the increased risk of congestive heart failure and serious liver problems. The first drug classified as a thiazolidinedione, Rezulin, was removed from the U.S. market on March 21, 2000 after more than 60 people died from liver failure.
In May 2007, the New England Journal of Medicine published an analysis linking Avandia to increased risk of heart attacks. The meta-analysis reviewed 42 studies and found patients taking Avandia® to be at a 43% higher risk of heart attack or other cardiovascular-related risk.
Avandia FDA Alert
The FDA issued a May 21, 2007, alert about safety data from clinical trials that showed a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. The FDA advised patients to discuss treatment options with their doctor if they are taking Avandia and have underlying heart disease or are at high risk of heart attack. Additionally, prominent scientists have raised concerns about Avandia, specifically whether the drug's safety should have been more extensively tested before being offered to patients. "The FDA rushed to approve Avandia, " said Dr. Nissen, a renowned cardiologist at the Cleveland Clinic, at the June 2007 annual meeting for the American Diabetes Association. "In my view that was a regulatory mistake. A strong safety signal of excess cardiovascular events was ignored."
FDA Restrictions on Avandia
On Wednesday, July 14, 2010, following two days of extensive investigation and discussion, the majority of a federal medical advisory panel recommended that Avandia have sales restricted and additional label warnings added or be completely withdrawn from the market because the drug may increase risks associated with heart attacks. The Avandia restrictions were placed, in part, due to panel members' skepticism involving the integrity of studies sponsored by GlaxoSmithKline. The FDA is considering regulatory options.