FDA Votes to Restrict Avandia Due to Risks
Jon L Gelman is investigating cases involving individuals who have suffered a heart attack, ischemic stroke or other cardiac condition while taking Avandia for diabetes. Avandia is a drug 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.
Avandia, like other thiazolidinediones, can cause fluid retention which may lead to heart failure. Injuries associated with Avandia use can include:
· congestive heart failure or heart damage
· deep vein thrombosis
· heart attack
· hemorrhagic stroke
· increased incidence of bone fractures in females
· ischemic stroke
· sudden cardiac death
If you or a loved one may have experienced any of the above symptoms while taking Avandia, you may contact Jon L. Gelman by email or call 1 973-696-7900.
Drug History and Serious Adverse Reactions
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.
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."
The US Senate released a report on February 20, 2010 revealing that GlaxoSmithKline had knowledge that possible heart attack risks were caused by diabetes drug Avandia many years before it was made public. The report concluded that, the company, “… had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.”
On July 13, 2010 a federal medical advisory panel, by majority vote, recommended that Avandia should either be withdrawn from the market or have severe restrictions imposed for its continued sale.