November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.
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Statement of NCHR At the April 8, 2009 FDA Psychopharmacologic Drugs Advisory Committee Meeting Regarding Seroquel XR
April 8, 2009. We testified arguing that Seroquel, an Antipsychotic medication, should be kept off the market as it has not been conclusively proven that it does not increase the risk of diabetes or tardive dyskinesia.
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