Patients taking AstraZeneca’s antipsychotic Seroquel have an almost 400% increased risk of developing diabetes, an endocrinologist has told a US court.
The court case is the first case to trial of about 9,000 US lawsuits against the Anglo-Swedish drugmaker over claims Seroquel (quetiapine) is linked to diabetes and other conditions.
Jennifer Marks, a Miami-based endocrinologist, is testifying in a pre-trial hearing on behalf of Linda Guinn, who claims the use of Seroquel caused her diabetes. “Seroquel is a substantial factor in diabetes and weight gain,” Marks told the court, a Bloomberg.com report said.
According to a 2004 study, published in a journal of the American Psychiatric Association, which compared newer antipsychotics with first-generation drugs, males who took Seroquel for at least 60 days had an increased risk in diabetes. Meanwhile, a US Food and Drug Administration study in 2004 found reports of high glucose levels matched an increase in Seroquel prescriptions between 1997 and 2002. Both studies, along with four others, were cited by Marks as evidence of a link with diabetes.
AstraZeneca defended the drug in an interview with Bloomberg. “This is a minute selection of the scientific data available on Seroquel. The totality of the evidence that has been presented to the FDA shows that Seroquel is safe and effective,” said spokesman Tony Jewell.
The company is aiming to bar the testimony on the grounds of contradictory studies. However, the company is facing problems in getting its once-daily extended-release version of the drug approved in the US for major depressive disorder after the FDA requested more information before it would consider approving the new indication.
Further details have not been disclosed.
By Katrina Megget
PharmaTimes
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