F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

The Food and Drug Administration has taken an important step to expanding access to the antipsychotic clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating mental illnesses .

The agency announced Monday that it was eliminating the requirement that patients submit blood tests before their prescriptions are met.

Clozapine, approved in 1989, is considered by many physicians as the most effective treatment for schizophrenia. Research shows that this drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, and a decrease in white blood cell count can be life-threatening in its most severe form.

In 2015, federal regulators imposed a regimen known as risk assessment and mitigation strategies, or REMS, where patients submit to weekly, biweekly, and monthly blood tests, upload to a database, and verify by a pharmacist. It didn’t.

Doctors have long complained that clozapine is ineffective as a result.

Dr. Frederick C. nucifora, director of the Johns Hopkins School of Medicine’s Adult Schizophrenia Clinic, believed that about 30% of patients with schizophrenia would benefit from clozapine.

“I was doing it badly, I had a lot of patients who struggled to function outside the hospital and were circulating a lot of medication,” he said. “When they go to clozapine, they really tend not to be hospitalized again. I’ve had people finish college and finish work. That’s pretty amazing.”