AstraZeneca Accused of Burying Seroquel Concerns

AstraZeneca, the British drug company behind the blockbuster antipsychotic Seroquel, prevented company scientists from going public with their concerns that the drug caused weight gain and other complications, according to lawyers suing the company.

The company reportedly feared that releasing the concerns about adverse effects from Seroquel might hurt sales of the drug, said plaintiff’s attorneys citing a string of internal emails just released as part of thousands of lawsuits against AstraZeneca.

About 15,000 lawsuits have been filed on behalf of Seroquel patients for injuries allegedly caused by the drug. Seroquel has been linked to weight gain, diabetes and other blood-sugar disorders, and pancreatitis. Seroquel was approved by the Food and Drug Administration in 1997 as a new generation of antipsychotics to treat bipolar disorders and depression. The drug’s labeling warns of the risks of blood-sugar disorders and other side effects.

Company Emails Show Deception, Other Tactics

Internal AstraZeneca emails about data indicating that Seroquel was “not very effective” and could produce severe side effects were “either spun or skewed or outright concealed,” according to Ed Blizzard, a Houston attorney who represents about 6,000 Seroquel plaintiffs.

In other emails, AstraZeneca officials discussed using Seroquel for dementia patients, even though the FDA had not approved the drug for treatment of that condition, attorneys said. While doctors may use drugs for unapproved uses, drug companies are forbidden from promoting drugs for “off-label” treatments.

The emails also reveal that company marketing officials tried to downplay the findings of their scientists that Seroquel caused patients to gain weight, attorneys said. Data showed that one in four of patients taking the drug increased their weight by at least seven percent.

So far, hundreds of AstraZeneca emails regarding Seroquel have been released to plaintiff’s attorneys as part of the litigation of about 6,000 lawsuits.

Drug Maker Seeking Broader Approvals

Seroquel is a top-seller for AstraZeneca, having earned $4.5 billion in sales in 2008. The company is seeking FDA approval to use the drug for treatment of depression and anxiety disorders, conditions which affect about 20 million people.

An FDA advisory panel recently recommended against the broader approvals, saying that issues including weight gain, blood-sugar disorders, and other complications associated with Seroquel raise red flags. The FDA is expected soon to issue a ruling on the request to expand Seroquel’s approvals.

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