Last week, an FDA Advisory Committee voted against the approval of the atypical antipsychotic, Seroquel, to treat General Anxiety Disorder and Major Depressive Disorder in adults because the benefits of the drug for those indications did not outweigh the risks.
“Extension of labeling to these common indications would likely result in the exposure of hundreds of thousands if not millions of patients to substantial medical risks without significant clinical benefit to justify these risks,” Harrisburg Pennsylvania psychiatrist, Stefan Kruszewski, told committee members in a submission to the panel.
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In terms of overall prescription sales in the US, antipsychotics led all therapy classes in 2008, ahead of even cholesterol mediations, according to IMS Health.
The new class of antipsychotics comes with a host of serious adverse effects. One section of the briefing documents submitted to the FDA advisory committee states:
“Atypical antipsychotics have been associated with several safety issues. Among the major safety issues are increased mortality in elderly patients with dementia-related psychosis, suicidality in children and adolescents, clinical worsening and suicidality, neuroleptic malignant syndrome, tardive dyskinesia (TD), orthostatic hypotension, hyperglycemia and diabetes mellitus.”
As for the most worrisome, often non-reversible and disfiguring movement disorder, tardive dyskinesia, an FDA reviewer pointed out: “Although we have asked the sponsor in the 2005 meeting that the benefit/risk assessment must include tardive dyskinesia for this patient population, no additional assessment by the sponsor was identified in this submission.”
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