The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, a debilitating mental illness. The agency announced that it is eliminating the requirement that patients submit blood tests before their prescriptions can be filled. Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that it significantly reduces suicidal behavior. Clozapine is associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening. In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
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