FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

FDA APPROVES CLOZARIL TO REDUCE THE RISK OF SUICIDAL BEHAVIOR IN PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER

The Food and Drug Administration (FDA) has approved a new use for the schizophrenia drug, Clozaril: to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Clozaril was approved in 1989 for treatment of schizophrenia in patients who do not respond to other available therapies.

Schizophrenia, a disorder of the brain, affects about 1 out of 100 persons - with onset usually in young adults. About 20 to 40 percent of patients with schizophrenia and schizoaffective disorder attempt suicide. Suicidal behavior refers to actions by a patient that put the patient at risk for death.

Patients for whom Clozaril treatment may be useful are those who are judged to be at chronic risk for reexperiencing suicidal behavior, based on history of attempted suicide, hospitalization, or suicidal ideation (thoughts of suicide) with or without hallucinations.

The effectiveness of Clozaril in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the International Suicide Prevention Trial (InterSePT) - a trial of 980 patients that compared Clozaril to olanzapine (Zyprexa). It is recommended that Clozaril treatment to reduce the risk of recurrent suicidal behavior should be continued for at least two years. FDA is advising the health care community that a majority of patients in both the Clozaril arm and the olanzapine arm of the trial received other treatments to reduce the suicide risk, including antidepressants and other medications, hospitalization and psychotherapy. The contributions of these additional measures are unknown.

Because patients who take Clozaril are at risk for a life-threatening blood disorder, called agranulocytosis, they must have frequent blood tests. These tests are necessary to detect the blood disorder at an early stage so that the patient can stop taking the drug immediately if necessary. Another common serious side effect is seizures.

The annual number of suicides associated with schizophenia per year in the United States is estimated to be about 3600. The estimated cost of a suicide attempt averages $33,000, primarily due to hospital costs.

Clozaril tablets are manufactured and marketed by Novartis of East Hanover, N.J.

####

Media Contacts   |   FDA News Page   |   FDA Home Page

Office of Public Affairs
Web page created by smc 2002-DEC-19.