Magazine article Clinical Psychiatry News

Clozapine Can Reduce Suicide Risk, FDA Says. (Patients with Schizophrenia)

Magazine article Clinical Psychiatry News

Clozapine Can Reduce Suicide Risk, FDA Says. (Patients with Schizophrenia)

Article excerpt

GAITHERSBURG, MD. -- A claim that treatment with clozapine can reduce the risk of recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder has been approved by the Food and Drug Administration. This is the first time a suicidality claim has been approved for any medication.

The FDA approved the clozapine (Clozaril) claim late last month, 6 weeks after its Psychopharmacologic Drugs Advisory Committee concluded that available evidence provided a sufficient basis for approving such a claim. Seven of the nine panel members agreed that overall, the findings of the International Suicide Prevention Trial (InterSePT), together with data from the clozapine national registry and elsewhere, supported this claim in people with schizophrenia. InterSePT was a prospective, multicenter, international, open-label trial, 980 patients with schizophrenia or schizoaffective disorder, at high risk for suicide, were treated with either clozapine or olanzapine (Zyprexa).

Treatment is recommended for at least 2 years to reduce the risk of recurrent suicidal behavior, according to the FDA.

The agency is also advising health care professionals that most of the patients in the clozapine and olanzapine arms of the trial were receiving other treatments aimed at reducing their risk of suicide, including antidepressants and other medications, psychotherapy, and hospitalization. "The contributions of these additional measures are unknown," the agency said in a statement announcing the approval.

Approved in 1990, clozapine is indicated for treating "severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia." Novartis, which markets clozapine, has proposed that it also be approved for "reducing the risk of emergent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk for emergent suicidal behavior, based on history and recent clinical state. …

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