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(NaturalNews) Drug giant AstraZeneca instructed its sales representatives to tell doctors that there was no link between its antipsychotic drug Seroquel and an increased risk of diabetes, even though studies conducted by the company had already shown otherwise, according to documents uncovered as part of a lawsuit.
AstraZeneca is the target of more than 9,000 lawsuits alleging that the company concealed information about the diabetes risks posed by Seroquel and that it illegally marketed the drug for "off label" uses not approved by the FDA.
Seroquel is approved only for the treatment of schizophrenia and bipolar disorder, but is also prescribed off-label to treat anxiety and insomnia.
When Seroquel was introduced in 1997, its label included a mention of the risk of abnormal weight gain and diabetes within the "Adverse Reactions" documentation on its label, but was not required to carry a separate warning about these effects. Evidence suggests that the company knew early on that these two side effects were more common and serious than others that might occur, however.
In a February 1997 email uncovered as part of the lawsuit, an AstraZeneca official praises the company for carrying out a "great smoke-and-mirrors job" in convincing U.S. and Canadian regulators that a test linking Seroquel to weight loss was not significant. In a December 1999 internal email, the company's publications manager complains that AstraZeneca "cherry-picked" data from a study to make the drug seem safer and "buried" three studies with unfavorable results.
A 2005 voicemail from the company to its sales representatives instructs them to tell anxious doctors that there is no data implicating Seroquel as a cause of diabetes. Yet in 2000, the company had sent a position paper to the government of the Netherlands acknowledging that Seroquel could increase the risk of the disease.
In 2003, the FDA required that information on diabetes and weight gain be moved from the "Adverse Reactions" section of the label to the "Warnings" section. In early 2009, it required more information on the risks of increased blood sugar levels, appetite, cholesterol and weight in children and adolescents.
Sources for this story include: www.newsinferno.com.
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