Flawed FDA Safety Requirements Are Hamstringing a Highly Effective Treatment for Severe Schizophrenia

May 5, 2022

(STAT News) – Despite having impressive efficacy and being a relatively inexpensive generic drug, clozapine is rarely prescribed in the U.S. largely because of its onerous REMS requirements. At issue is a rare but potentially life-threatening side effect called agranulocytosis, a serious decline in neutrophils, a type of blood cell important for fighting infection. To prevent and rapidly address cases of agranulocytosis, the FDA requires clozapine’s manufacturers to jointly administer the clozapine REMS program. This aims to verify patients’ recent proof of normal neutrophil counts before pharmacies can dispense clozapine, meaning patients must visit a lab for blood draws as frequently as once a week. (Read More)