Saturday, May 16, 2009

Cardiac Risks Hold Up Approval of Two Antipsychotics

FDA advisors remain skeptical about the safety of two antipsychotics for which regulatory approval is being sought and are especially troubled by potentially fatal cardiac risks.

Despite positive efficacy data from placebo-controlled trials, experts on a Food and Drug Administration (FDA) psychopharmacology advisory committee have reservations about potentially dangerous adverse effects of two antipsychotic medications under regulatory review for approval.

The FDA held meetings in April to seek the committee's advice on whether sertindole, a second-generation antipsychotic (SGA), should be approved for the treatment of schizophrenia and prevention of suicide in schizophrenia patients, and whether quetiapine XR extended-release tablets should be approved for treating major depressive disorder (MDD) as a monotherapy and as an adjunctive therapy to an antidepressant and for treating generalized anxiety disorder (GAD) as a monotherapy.


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