Clozaril (clozapine)

Clozaril is used to treat schizophrenia in patients who have not been helped by or are unable to take other medicines (treatment resistent schizophrenia patients).

Clozapine is effective for about 60 percent of those who try it. A patient should try clozapine for at least four to six weeks. Some symptoms, such as hallucinations, anxiety, paranoia, and bizarre behavior, should improve within that time; other symptoms may take longer. Additional improvements may be noticed over six to twelve months.

Benefits and Risks of Clozaril

Clozapine has unique benefits and unique risks. The benefits make it a source of hope for the substantial number of patients with schizophrenia who have not responded well to traditional antipsychotic medications. Although clozapine use has certain risks, a careful monitoring system has been designed to manage and minimize them.

Unique Risks of Clozaril

One to two percent of patients who take clozapine will develop a condition called agranulocytosis, in which the white blood cell count drops dramatically. The patient becomes extremely vulnerable to infections and unable to fight them off. This condition is dangerous and potentially fatal. Fortunately, if agranulocytosis does occur, most patients can be successfully treated by stopping clozapine. In addition to stopping clozapine, hospitalization and treatment with a drug that increases white blood cell production are available.

Agranulocytosis incidence with clozapine is over 10 times that of other antipsychotics.

Clozaril is available only from pharmacies that agree to participate with your doctor in a plan to monitor your blood tests. You will need to have blood tests done every week for at least 6 months. After that, your doctor will decide if it is safe for you to have blood tests every other week. You will receive enough clozapine to last until your next blood test, but only if the results of your blood tests show that it is safe for you to take this medicine. If any of your blood tests are not normal, you may need to have blood tests more often than every week until they return to normal.

Benefits of Clozaril

Unique effectiveness: In responsive patients, clozapine adds another alternative to the traditional antipsychotics in treating the positive symptoms of schizophrenia such as hallucinations, delusions, bizarre behavior and hostility. It also effectively treats the negative symptoms - withdrawal, blunted emotions, lack of motivation, and inability to experience pleasure or enjoyment. It is the negative symptoms which seem to respond better to clozapine than to the traditional antipsychotics.

Lack of usual side effects: Clozapine has virtually no incidence of the muscle spasms, cramps, and posturing movements common to neuroleptic (antipsychotic) drugs, and minimal incidence of the less serious neurological side effects such as restlessness, muscle rigidity, and tremor (extrapyramidal side effects or EPS).

Furthermore, clozapine does not seem to cause tardive dyskinesia (TD), a disfiguring side effect of standard antipsychotic drugs. TD is characterized by involuntary movements such as grimacing, sucking and smacking of lips, and spasmodic movements of the extremities. It usually begins after several months of treatment and may be irreversible. There have been no confirmed cases of TD directly caused by clozapine alone.

Do the benefits of clozapine outweigh the risks?

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Clozapine poses a unique risk. Consequently, the FDA would not have approved it unless its effectiveness was proven clearly superior to that of current antipsychotic drugs. This was done conclusively in a 16-center study involving over 300 severely ill patients. These patients had been ill for many years and had failed to respond to at least three potent drugs.

In other studies of clozapine patients, 55 percent of previously hospitalized patients were able to work at paying or volunteer jobs or return to school, and re-hospitalization was reduced by 83 percent after 12 months. This improvement in psycho-social functioning was largely due to clozapine response.

Other risks associated with clozapine

Seizures may occur in roughly one to five percent of patients. The higher the dose, the greater the risk of seizures. Cardiovascular and respiratory side effects are also possible but extremely rare. Lowered blood pressure and increased heart rate can usually be managed by gradually increasing a patient's clozapine dosage from an initially low level. Some patients may notice weight gain, drooling, and initial lethargy but can be managed by dose titration (adjustment) or other interventions.

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