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Seroquel Lawsuit Lawyers Say Internal Documents Discuss Off-Label Use

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Some plaintiffs’ lawyers representing people involved in Seroquel lawsuits will present documents at a news conference today that they claim show  AstraZeneca  executives discussed promoting the off-label use of the drug in children and elderly  patients.  Off-label uses are those that have not been approved by the Food & Drug Administration (FDA).  Doctors are permitted to use any approved drug in any way they see fit, but drug makers are legally barred from promoting off-label use.

In a Wall Street Journal report published today, some of those documents were detailed.  They include one that cited plans to “broaden Seroquel use on and off-label,” including among adolescents and patients with Parkinson’s and Alzheimer’s disease, at medical meetings, in sales calls and with patient-advocacy groups,” the Journal said.

In one 2001 public relations plan reviewed by the Journal, one of the stated objectives was to “encourage and support” Seroquel’s “use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly”.  The same document also said there was a need for “aggressive market penetration” among adolescents, the elderly, patients with bipolar disorder and other groups for Seroquel to grow faster than rivals, the Journal said.

According to The Wall Street Journal, an AstraZeneca official denied that any of the documents indicate a desire on the part of the company to promote off-label uses of Seroquel.  Rather, the documents indicate the company’s plan to “explore additional indications for Seroquel and included that in clinical-development plans designed to support efforts to investigate potential additional indications,” the spokesperson said.

Seroquel – which was introduced in 1997 – is  approved to treat psychotic disorders, schizophrenia and bipolar disorder. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.

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