Lawsuit plaintiff wants documents unsealed before FDA approves Seroquel XR: depression & anxiety
From the StarTribune:
"TRENTON, N.J. - A patient who claims the psychiatric drug Seroquel gave him diabetes has asked a judge to unseal maker AstraZeneca's confidential documents about its side effects before U.S. regulators decide whether to approve a version of the drug for millions of new patients."
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A panel of FDA advisors will be meeting on April 8, 2009 to review and consider AstraZeneca's request to market Seroquel XR (extended release version)for depression and anxiety. Due to the lawsuit and current court trial, Ted Baker has requested the judge unseal 19 specific confidential documents, to be presented to the panel for review. Some of the internal documents detail the safety data for Seroquel believed not to have been seen by the FDA.
Time is of the essence for the FDA advisory panel to decide whether or not to approve a drug with known side effects such as diabetes, high blood pressure and death; while the drug manufacturer AstraZeneca is on trial for concealing data and information regarding Seroquel.
It is my opinion, it would be reckless endangerment of lives to broaden the approval of an antipsychotic for depression and anxiety when such data is suppressed and the company is on trial for doing so.
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1 comments:
it will be really interesting to see if our new female FDA commissioner has, excuse me, the balls to put a stop to this madness. or start airing the dirty laundry...SOMETHING. ANYTHING.
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