According to testimony presented by an expert witness at pre-trial hearings last week, Seroquel side effects increase the risk of diabetes by nearly four times when compared with older anti-psychotic medications.
The first Seroquel lawsuit is scheduled for trial to begin next month in the U.S. District Court for the Middle District of Florida, where all federal cases have been consolidated as part of a multidistrict litigation, or MDL.
The testimony was offered during hearings on AstraZeneca’s attempts to bar certain experts offered by the plaintiffs from testifying at trial.
Seroquel is a newer atypical antipsychotic which was first approved by the FDA in 1997 for treatment of schizophrenia. Use of the drug has recently been expanded to include treatment for bipolar disorders, and a new drug application is currently pending with the FDA seeking approval to market an extended release version for people with major depressive disorders.
Over 9,000 Seroquel lawsuits involving more than 15,000 plaintiffs have been filed against AstraZeneca on behalf of individuals who developed diabetes and other health problems allegedly caused by side effects of Seroquel which could result in severe weight gain.
According to Bloomberg News, testimony was presented on January 15, 2009, from endocrinologist Dr. Jennifer Marks, indicating that the risk of weight gain and diabetes from Seroquel side effects is increased 389 percent when compared to first-generation drugs in the same class.
The opinion that Seroquel causes diabetes was based on at least six studies. However, AstraZeneca claims that this is unreliable testimony and only involves a small portion of available data. They have maintained that based on the totality of the evidence, Seroquel is safe and effective.
Last month, as part of pre-trial motions filed with the Seroquel Court, internal documents from AstraZeneca were publicly disclosed which indicate that the drug maker’s own global safety officer concluded there was reasonable evidence of Seroquel diabetes side effects based on data available to the drug maker very early on after Seroquel was introduced.
The first Seroquel trial is scheduled to begin on February 2, 2009, involving a case selected by plaintiffs in the litigation. The second trial, which is scheduled to begin March 2, 2009, will be a case selected by the defendants.
The bellwether trials are supposed to be representative of issues that may be presented through out other Seroquel lawsuits pending in the ligation.