Internal documents disclosed during the litigation over Seroquel suggest that AstraZeneca continued to promote the antipsychotic drug as weight neutral, years after clinical evidence demonstrated significant Seroquel weight gain problems for users, which could lead to diabetes and other serious side effects.
A 2001 letter from a marketing official revealed that the pharmaceutical giant had a global strategy aimed at casting Seroquel as “weight neutral”, according to a report by Bloomberg News. This letter was written four years after the drug company’s own research found “clinically significant” weight gain among users of Seroquel.
The evidence was presented during a pretrial examination of John Patterson, a former AstraZeneca executive who reported directly to the company’s CEO. The 2001 letter appeared to directly contradict a 1997 email from one of AstraZeneca’s doctors that reported 45% of patients gained significant weight with Seroquel in a year.
Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $4.45 billion in sales in 2008. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.
Thousands of people have filed a Seroquel lawsuit against AstraZeneca alleging that the drug maker failed to adequately warn about the increased risk of diabetes, which is caused by the drug’s weight gain side effects. Among other things, plaintiffs argue that AstraZeneca actively concealed the diabetes risk with Seroquel when asked by U.S. doctors, even though they knew or should have known that there was a connection.
All federal Seroquel cases are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.
Other documents produced during Patterson’s testimony were used to used to suggest the company was promoting Seroquel for uses that had not been determined to be safe and effective by the FDA. A “Seroquel Strategy Summary” in 2000 reportedly described off label promotion as a goal.
While doctors are free to prescribe drugs for non-approved uses, it is illegal under current federal regulations for a drug company to promote their medications for such “off-label” use. Patterson estimated during his testimony that off-label use accounted for 30% to 40% of Seroquel sales, and admitted that percentage could be higher.
or off-label uses.