Drugs

Psychiatrist Blasts Clozapine REMS

Psychiatrist Brian Barnett says the effective and relatively inexpensive schizophrenia drug clozapine “is rarely prescribed in the U.S. largely because of its onerous REMS (Risk Evaluation and Mitigation Strategy) requirements.” Writing in a Stat online opinion piece, Barnett says the REMS is intended to address agranulocytosis, a rare but potentially life-threatening side effect.

“I see the clozapine REMS system as the biggest barrier to starting patients on this potentially life-saving drug,” Barnett writes, “indirectly causing more harm than good for people with schizophrenia.”

He notes that FDA suspended some REMS requirements after an 11/2021 system upgrade experienced significant issues.

According to Barnett, clozapine improves symptoms for about 40% of patients taking it, but fewer than 6% of eligible U.S. patients receive it. “While prescriber anxiety about agranulocytosis and other side effects certainly plays a role in underprescribing clozapine,” Barnett says, “as does a lack of centralized services to manage people taking it, the complexity of navigating the REMS requirements is the biggest deterrent.”

Barnett calls the agency’s focus on agranulocytosis “myopic,” saying it occurs in just eight of every 1,000 people taking the drug and 97% of them survive it. Further, he says, the risk of death from agranulocytosis after the first six months on clozapine is about the same as general life mortality risks such as traffic or occupational accidents.

“That FDA has mandated such a flawed clozapine risk mitigation approach for so long without more opposition from within medicine speaks to the extreme marginalization of people with schizophrenia in our healthcare system,” Barnett concludes. “What else could explain why a highly effective antipsychotic is saddled with such cumbersome regulations, while providers routinely prescribe many other medications with similar agranulocytosis risks that have no REMS requirements?”

He calls on FDA to immediately relinquish decision-making around clozapine neutrophil monitoring and place it entirely in the hands of prescribers. He also calls for an urgent, comprehensive inspection of the entire REMS system.

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