The FDA implemented a significant change to make clozapine, the only prescription drug for treatment-resistant schizophrenia, more widely available. Patients once had to undergo frequent blood tests before they could have their prescriptions filled because of a potentially lethal but rare side effect, neutropenia, which decreases white blood cell levels and compromises the immune system. But after years of complaint from doctors, pharmacists, and families, the FDA eliminated this requirement.
Clozapine is available since 1989 and is considered by many specialists to be the ideal treatment for schizophrenia, particularly for patients who fail to respond to other pharmacologic treatment. It is proven to decrease suicidal activity significantly and help people regain control over their lives. While much is offered by the drug, only about 4% of schizophrenic patients use it, though almost 30% may gain from it. Doctors are of the opinion that the rigid restrictions regarding blood monitoring have dissuaded doctors from using the drug, inducing undue suffering on the part of many patients.
Patients, families, and supporters—physicians and pharmacists—pleaded years to remove the testing requirement, sharing stories of patients who had relapsed into psychosis, had become violent, or had been hospitalized after losing clozapine access. So many individuals wanted to be heard when the FDA reconsidered the rule in November that the agency had to extend its public forum. The FDA eventually concluded that routine blood testing was no longer required as the risk of severe neutropenia is extremely low, particularly after the initial six months of treatment. That being said, there are some who are unsure that the change will result in a drastic increase in prescriptions because physicians are still reluctant to prescribe clozapine because of the requirement for close monitoring during the initial phase.
Schizophrenia is a serious mental disease that occurs in approximately 1%–3% of adults and carries much greater risk for suicide. Homelessness, multiple hospitalizations, and unemployment are common issues for patients, and the overall cost is $343.2 billion annually. New treatments are infrequent, but Cobenfy, the first new antipsychotic medication in decades, has been licensed by the FDA, giving promise for improved therapy in the future.
Source: www.nytimes.com/2025/02/25/health/clozapine-schizophrenia-fda.html
