FDA Makes Access to Clozapine Easier for Patients With Schizophrenia

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The U.S. Food and Drug Administration has removed one hurdle faced by patients with schizophrenia when filling prescriptions for the antipsychotic medication clozapine.

The agency has eliminated the need for pharmacists to verify a patient’s white blood cell count before dispensing the medication. Neutropenia is a rare side effect of clozapine, and severe cases can be life-threatening. The blood test was a necessary part of a regimen known as risk evaluation and mitigation strategies, or REMS. The regimen required patients to undergo weekly, biweekly, and monthly blood tests, the results of which were uploaded to a database accessible by pharmacists.

“Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk,” the agency said in a medication update. “FDA still recommends that prescribers monitor patients’ absolute neutrophil count according to the monitoring frequencies described in the prescribing information.”

Long considered an undue burden on clinicians, patients, and pharmacists wanting to use clozapine to treat schizophrenia, the removal of this regulation was met with relief. According to Frederick C. Nucifora, M.D., director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, as many as 30 percent of patients with schizophrenia would benefit from clozapine.

“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” Nucifora told The New York Times. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”

The New York Times Article

Source: HealthDay

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