The US Food & Drug Administration (FDA) has eliminated a longstanding requirement that patients taking clozapine, an anti-psychotic used for treatment-resistant schizophrenia, to submit blood test results before their prescriptions can be filled.
The move is aimed at reducing barriers to access for the medication, while still recommending that prescribers monitor patients’ absolute neutrophil count, reports Becker’s Hospital Review.
Clozapine, approved in 1989, is considered one of the most effective treatments for schizophrenia and has been shown to reduce suicidal behaviour. However, it carries a rare but serious risk of neutropenia, a potentially life-threatening drop in white blood cell counts.
Since 2015, the FDA has required a risk evaluation and mitigation strategy programme, mandating frequent blood tests and database reporting before pharmacies can dispense the drug.
Studies 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 hospitalisations and resuming normal lives.
Becker’s Hospital Review article – FDA expands access for schizophrenia treatment (Open access)
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