Schizophrenia drug gains FDA approval.

Schizophrenia drug gains FDA approval

The Food and Drug Administration last week approved a drug for treating severe schizophrenics who fail to respond to standard antipsychotic medications. The action followed detailed review of a study in which nearly one-third of formerly untreatable schizophrenics given the drug clozapine at hospitals throughout the United States improved markedly (SN: 5/23/87, p. 324).

"The severity and hopelessness of chronic schizophrenia was an important factor in the decision to approve clozapine," says FDA Commissioner Frank E. Young.

Because about 1 percent of those given clozapine develop agranulocytosis -- a potentially fatal drop in infection-fighting white blood cells -- the FDA says physicians can prescribe the drug only for patients who have not responded to at least two standard antipsychotic drugs. Clozapine can also cause seizures, but it rarely produces the severe movement disorders associated with standard antipsychotic drugs (SN: 7/20/85, p. 45). About 200,000 people in the United States are candidates for clozapine treatment, according to the FDA.

Clozapine, like other antipsychotic drugs, does not cure schizophrenia. Among patients who improved in the study, however, it reduced hallucinations, delusions, disordered thinking, social withdrawal and apathy. Those individuals can now leave the hospitals to enter community rehabilitation programs.

Schizophrenics who receive clozapine must participate in a special testing program. A home health care company will deliver the medication to patients each week and collect blood samples for analysis by a national laboratory. If early signs of agranulocytosis show up, the laboratory will notify the patient's physician immediately.

The medication will be sold under the trade name Clozaril by Sandoz Pharmaceutical Corp. of East Hanover, N.J.