Jan. 16 (Bloomberg) — AstraZeneca Plc’s antipsychotic drug Seroquel raised by almost 400 percent the risk of developing diabetes when compared with first-generation medications in its class, a doctor testified in a court case against the drugmaker.
A 2004 article published in Psychiatric Services, a journal of the American Psychiatric Association, reported the increased risk in males who were exposed to Seroquel for at least 60 days. The study, which involved 1,629 patients, compared the exposure of a newer class of antipsychotics including clozapine and Seroquel with an older class of drugs, Jennifer Marks, a Miami- based endocrinologist, said during a pre-trial hearing yesterday in federal court in Orlando, Florida.
“Seroquel is a substantial factor in diabetes and weight gain,” Marks said, noting the 389 percent rise.
AstraZeneca, the U.K.’s second-largest drugmaker, faces about 9,000 lawsuits in the U.S. over claims Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the London-based company’s second-biggest seller after the ulcer treatment Nexium. Marks testified on behalf of former Seroquel user Linda Guinn, the first case to come to trial over the drug.
Marks cited six studies bolstering her opinion that Seroquel causes diabetes. A 2006 study in the Journal of Clinical Psychiatry noted that more than 40 percent of 920 patients with diabetes who were exposed to antipsychotics for three months had received the class of drugs that includes Seroquel.
Another study from the U.S. Food & Drug Administration in 2004 found that reports of high glucose levels increased with the number of Seroquel prescriptions between 1997 and 2002, Marks said.
“This is a minute selection of the scientific data available on Seroquel,” Tony Jewell, an AstraZeneca spokesman, said in an interview yesterday. “The totality of the evidence that has been presented to the FDA shows that Seroquel is safe and effective.”
AstraZeneca fell 34 pence, or 1.3 percent, to 2,689 pence in London trading.
Guinn blames Seroquel for her February 2006 diabetes diagnosis. The drug, which is cleared to treat schizophrenia and bipolar disorder in the U.S. and Europe, is part of a class of newer antipsychotic drugs including Eli Lilly & Co.’s Zyprexa and Bristol-Myers Squibb Co.’s Abilify.
AstraZeneca’s lawyers, who are seeking to bar the testimony of Marks and other expert witnesses, argued there were contradictory studies on the links between Seroquel and diabetes. They attribute Guinn’s diabetes to obesity, a family history of the disease and hypertension.
The case is In re Seroquel Products Litigation, 06-01769, U.S. District Court, Middle District of Florida (Orlando).
By Sophia Pearson and Doris Bloodsworth
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