Schizophrenia Drug Approved With Test Plan
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WASHINGTON — The federal government on Tuesday approved a new drug to treat severe schizophrenia and a monitoring program in which patients using the drug will be tested weekly for signs of a potentially fatal side effect.
The Food and Drug Administration said the drug, clozapine, can be used only for patients who have not responded to at least two regimens of standard, less toxic therapy.
An estimated 200,000 people could benefit, the FDA said.
The drug has been shown to relieve symptoms of severe schizophrenia, allowing patients to lead more productive lives. But it also can cause a potentially fatal blood disorder in which the level of white blood cells is reduced. Studies have shown the condition can be reversed if caught early.
The drug also is associated with seizures, officials said.
Under the monitoring system, a home health care company will distribute the prescribed medication to patients each week and collect blood samples that will be sent to a national laboratory for analysis, the FDA said. If the test results indicate that the patient must stop taking the drug, the patient’s doctor will be notified.
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