The move is aimed to reduce barriers to access for the medication, while still recommending that prescribers monitor patients’ absolute neutrophil count, according to a Feb. 24 FDA news release.
Clozapine, approved in 1989, is considered one of the most effective treatments for schizophrenia and has been shown to reduce suicidal behavior. However, it carries a rare but serious risk of neutropenia, a potentially life-threatening drop in white blood cell counts, The New York Times reported Feb. 25.
Since 2015, the FDA has required a risk evaluation and mitigation strategy program, mandating frequent blood tests and database reporting before pharmacies can dispense the drug.
Studies also suggest that around 30% of schizophrenia patients could benefit from clozapine, but only about 4% currently receive it. Some physicians report that patients who previously struggled with other treatments have seen life-changing improvements from clozapine with some avoiding hospitalizations and resuming normal lives, according to the Times.