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Seroquel Lawsuits: The Problem with Off-Label Use of Seroquel

Seroquel (generic quetiapine fumarate), is an antipsychotic medication manufactured by AstraZeneca. The FDA approved the drug in 1997 to treat schizophrenia, but additional off-label uses to treat anxiety, obsessive-compulsive disorders, dementia, and autism are where the big money is for AstraZeneca. And big money it is. Seroquel had $3.4 billion in sales in 2006 alone. 88 countries approved Seroquel to treat schizophrenia, 79 countries approved it to treat bipolar mania, and in 11 countries including the U.S. approved it to treat bipolar depression. Last week AstraZeneca sought approval for its more recent creation, Seroquel XR (quetiapine fumarate) both in the treatment of manic episodes and the treatment of depressive episodes associated with bipolar disorder.

It may well be that Seroquel is efficacious in treating these symptoms. But there are increasing reports about the increased risk of diabetes pancreatitis in patients taking Seroquel. The FDA has warned of diabetes risks from Seroquel and the labeling has changed in Seroquel. But Seroquel remains on the market today.

At a congressional hearing on drug safety, Dr. David Graham, an FDA drug safety expert, was asked about concerns he had on drugs available today. Dr. Graham testified that “I would pay careful attention to antipsychotic medications. The problem with these drugs are that we know that they are being used extensively off-label in nursing homes to sedate elderly patients with dementia and other types of disorders… But the fact is, is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications…. With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank.” Fifteen thousand people is an incredible number of people to die. But there is no uproar, and the drug remains on the market.

You might ask how it has achieved sales of $3.4 billion dollars while the FDA has only approved atypicals for bipolar disorder and schizophrenia, diseases that affect just 1 percent of us. In fact, Seroquel is third on the hit parade–two other atypicals, Risperdal and Zyprexa sell more than Seroquel. The sales reps for the companies that sell Seroquel, Risperdal, and Zyprexa are good at their jobs and they know how to push these drugs on doctors who they well know are not treating bipolar or schizophrenic patients.

2013 Update: Most Seroquel lawsuits have been resolved or settled. Our law firm is not accepting new Seroquel injury cases. If you missed out on bringing a claim…. honestly, you did not miss much. The cases settled for very little.

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