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AstraZeneca Plc failed to make public results of at least three clinical trials of its antipsychotic drug Seroquel, according to an e-mail sent by one of the company’s officials in December 1999. The e-mail was unsealed Thursday under an agreement between the company and lawyers for patients.
More than 15,000 patients have sued AstraZeneca, under claims that the company kept secret a connection between diabetes and Seroquel use from doctors and patients. Many of the lawsuits also say the company promoted the drug for unapproved uses. Seroquel was approved in 1997 by the US Food and Drug Administration for schizophrenia and bipolar disorder.
"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 the plaintiffs suing the British company. He further claims that the company knew as early as 1997 that Seroquel caused significant weight gain – a problem linked to the dramatic increase in new cases of Type 2 diabetes – and knew by 2000 that it cased diabetes in some patients.
“Our position was that the public has the right to know” what the documents contain, Blizzard said during a Friday afternoon teleconference.
On the other hand, company spokesman Tony Jewell said AstraZeneca “has studied Seroquel extensively and shared all relevant and required data with the FDA.” Moreover the company “believes that the Seroquel label has always provided adequate and appropriate information and warnings based on available data,” he added.
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