Seroquel Lawsuit Uncovers Documents Suggesting Intention to Promote Off-Label

According to internal AstraZeneca documents obtained during the litigation over side effects of Seroquel, which has been linked to an increased risk of diabetes and other injuries, the drug maker discussed intentions to promote the medication for off-label uses.

Seroquel is an atypical-antipsychotic which was approved for treatment of schizophrenia in 1997. Although a new extended release version was approved last year for treatment of bipolar disorders, Seroquel has been widely prescribed off-label for a variety of conditions that AstraZeneca never established were safe and effective, such as treatment of anxiety, obsessive compulsive disorders, dementia, insomnia and autism.

Although doctors are free to prescribe any approved medication for non-approved uses, off-label marketing by drug makers is illegal and can result in heavy fines and penalties. Some estimates have suggested that as much as 70% of all Seroquel prescriptions were for unapproved uses, yet AstraZeneca has denied that they ever promoted it inappropriately.

Private documents publicly released this week seem to suggest otherwise, indicating that off-label Seroquel promotion was a key marketing strategy for the drug maker as early as 2000.

One of the papers released had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.

Other documents released in March 2009, indicated that AstraZeneca was aware as early as 1997 that Serquel increased the risk of weight gain and diabetes. The pharmaceutical company attempted to indicate the drug was weight-neutral and doctors were told that there were no Seroquel diabetes problems, even though their own drug-safety acknowledged internally that there was evidence of a connection.

More than 15,000 people have filed lawsuits in state and federal courts throughout the United States against AstraZeneca alleging that they failed to adequately warn about the risk of serious Seroquel side effects, such as weight gain, hyperglycemia, diabetes and a rare movement disorder known as tardive dyskinesia. The documents were unsealed recently, allowing lawyers representing individuals in those lawsuits to publicly release the internal information before trial.

The first Seroquel lawsuit is scheduled for trial to begin June 29, 2009, in Delaware state court. The case involves claims by Nina Scaife, who developed diabetes after using the drug off-label for treatment of insomnia. All federal cases have been consolidated before one judge in an MDL, or multidistrict litigation, pending in the U.S. District Court for the Middle District of Florida.