AstraZeneca is facing more than 15,000 consumer claims alleging the antipsychotic drug Seroquel causes diabetes.
They knew about the risk as far back as 2000, according to company documents shown in federal court.
AstraZeneca Global Safety Officer Wayne Geller concluded there was “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.
The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company.
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Meanwhile...............
U.S. regulators complained that an AstraZeneca sales representative suggested an unapproved use of the company's schizophrenia drug Seroquel to a physician, according to a letter released on Thursday.
The Food and Drug Administration, in a letter to the company, said an AstraZeneca representative told a doctor in January 2008 that Seroquel was approved for treating depression. The doctor then requested information to support the claim, and AstraZeneca sent a mailing that summarized research studies of Seroquel in depression, the FDA said.
Seroquel and Seroquel XR are not approved for treating depression.
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