Seroquel Problems Mount for AstraZeneca as First Trial Approaches

The first of several thousand lawsuits filed by Seroquel users who claim that AstraZeneca failed to warn about serious side effects of Seroquel, is scheduled for trial to begin in February 2009, and the problems for the drug maker continue to increase.

On Thursday, the FDA posted a warning letter on their website, which accused AstraZeneca of marketing Seroquel for un-approved uses, which the company has not established are safe or effective.

Seroquel (quetiapine fumarate) is an atypical antipsychotic which has not been approved for treatment of major depressive orders, yet the letter indicates a sales representative pitched this “off-label” use to a doctor and even sent promotional materials and study results, which the FDA indicates suggested a new intended use for Seroquel.

Although doctors are free to prescribe approved medications for un-approved uses, drug companies are prohibited by federal law from promoting or encouraging such use. The FDA concluded the statements of the drug rep and written materials provided, constituted misbranding of Seroquel and Seroquel XR, and demanded that AstraZeneca stop distributing the promotional materials.

AstraZeneca has been previously accused of marketing Seroquel for “off-label” uses, and some experts have estimated that as much as 70% of all Seroquel prescriptions have been for unapproved uses since the drug was first introduced in 1997.

As of November 5, 2008, AstraZeneca indicates that they are aware of 9.060 Seroquel lawsuits that have been filed in state and federal court involving a total of 15,026 plaintiffs. This means that the over 1,500 people have filed lawsuits over the two month period since the last update, when AstraZeneca reported that as of August 27, 2008, over 13,300 plaintiffs were involved in the Seroquel litigation.

The cases involve allegations that AstraZeneca failed to adequately warn about the risk of severe weight gain, diabetes, pancreatitis and other serious medical conditions associated with the use of their drug.

Although AstraZeneca has indicated that they intend to defend the cases, in another damaging blow, an internal document was released last week which suggests that the company was aware of the Seroquel diabetes side effects as early as 2000, yet failed to warn users about the potential risk.

According to Bloomberg News, an internal document from the drug maker’s global safety officer, Wayne Geller, concluded that there was “reasonable evidence” that Seroquel side effects cause diabetes and related conditions. The conclusions were based on studies and data which were available to the drug maker very early on after the drug was introduced.

All federal lawsuits over Seroquel have been consolidated in an MDL, or Multidistrict Litigation, which has been centralized in the U.S. District Court for the Middle District of Florida.

The first trial is scheduled to begin in February 2009, and the internal documents were publicly disclosed during hearings on Thursday and Friday of last week on motions filed by AstraZeneca over the qualifications of expert witnesses the plaintiffs intend to call at trial.