Seroquel Lawsuits: The Problem with Off-Label Use of Seroquel
Seroquel (generic quetiapine fumarate), is an antipsychotic medication manufactured by AstraZenica. The drug was approved in 1997 for treatment of schizophrenia, but additional off-label uses to treat anxiety, obsessive compulsive disorders, dementia and autism are where the big money is for AstraZenica. And big money it is. Seroquel had $3.4 billion in sales in 2006 alone. Seroquel has been approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for bipolar depression. Last week AstraZenica 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 it 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 currently 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 are an incredible number of people to die. But there is no uproar and the drug remains on the market.
You might be asking how Seroquel 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 a great deal more than Seroquel. The sales reps for the companies that sell Seroquel, Risperdal, and Zyprexa are pretty 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.
AstraZeneca’s creative marketing efforts do not stop there.
In fact, back in 2006, the FDA sent a warning letter to drug maker AstraZeneca, frustrated that AstraZeneca had been claiming that some of the company’s promotional material for Seroquel contains false and misleading information. Specifically, the FDA charged that AstraZeneca failed to adequately provide the risks of hyperglycemia and diabetes and omitted important data about neuroleptic malignant syndrome and other important risks.
A co-conspirator in this mess is the nursing homes that would prefer to medicate elderly patients with dementia, regardless of the risk to them, because it is simply much easier and cost effective. In nursing homes, where resources are notoriously strained and patient care is often questionable at best, pharmaceutical options are the easiest play for the nursing home. Patients’ families are often inadvertently complicit because they are not told of the risks, only that the pharmaceutical option, if successful, will help the patient. According to a New York Times article on Friday, the pharmaceutical option of using this class of drugs for these patients may be highly overrated.
Obviously, Seroquel is not the only cause of diabetes, particularly for people of the age that are often taking the drug. But if you have diabetes or any of the risks associated with Seroquel, there is a potential link to the drug. If you think you may have a case, you can call one of our Seroquel lawyers for a free consultation at 800-553-8082 or click here for a free online consultation.
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