Documents Show AstraZeneca Knew of Seroquel Risks

By Linda A. Johnson

TRENTON, N.J. -- Internal AstraZeneca(AZN Quote) reports and emails written by company officials show they knew a decade ago that their psychiatric drug Seroquel caused diabetes and major weight gain, plaintiffs' lawyers said Friday after releasing dozens of the previously sealed documents.

"They not only failed to warn about the risk of diabetes, but they marketed it as not having that risk," said Houston attorney Ed Blizzard, one of the lead attorneys representing roughly 15,000 plaintiffs suing the British drugmaker.

The plaintiffs claim Seroquel, approved for treating schizophrenia and bipolar disorder, caused diabetes, weight gain and related health problems, from kidney failure and heart attacks to amputations and damage to the pancreas, which makes insulin.

AstraZeneca spokesman Tony Jewell said plaintiffs' lawyers are "mischaracterizing that we knew that it caused diabetes." He said it remains unresolved whether Seroquel causes diabetes, and that AstraZeneca PLC has shared all relevant and required data with the Food and Drug Administration, both before and after the FDA approved Seroquel as safe and effective in 1997.

"AstraZeneca believes that the Seroquel (detailed package insert) has always provided adequate and appropriate information and warnings based on available data," Jewell said.

Blizzard claims that the company knew as early as 1997 that Seroquel caused significant weight gain -- a problem linked to the surge in new cases of Type 2 diabetes -- and knew by 2000 that it caused diabetes in some patients.

"Our position was that the public has the right to know" what the documents contain, Blizzard told reporters during a Friday afternoon teleconference.