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FDA Eliminates Clozapine REMS Program Requirement
The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) program requirement for clozapine.
Clozapine, an atypical antipsychotic, is indicated for treatment-resistant schizophrenia and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. The Clozapine REMS program was established in 2015 due to the risk of severe neutropenia associated with the medication.
Prior to pharmacies dispensing clozapine, the FDA required patients to obtain and report a baseline absolute neutrophil count (ANC) blood test. In order to continue treatment, the ANC was to be monitored regularly.
In November 2024, the FDA held an in-person advisory committee meeting to reevaluate the clozapine REMS requirement. During this meeting, the committee voted 14 to 1 that the REMS requirement for ANC documentation was not necessary for the safe use of clozapine.
In a safety communication regarding clozapine, the Agency stated: "the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine."
Although the REMS program has been eliminated, the FDA still recommends prescribers monitor patients' ANC levels according to the prescribing information. According to the Agency, information about severe neutropenia will still be included in the prescribing information and Boxed Warnings section for all clozapine products.
The FDA has requested clozapine manufacturers submit a modification to remove the Clozapine REMS and update the prescribing information to remove the mandatory ANC blood test reporting to the REMS program.
References:
The FDA Finally Removes A Huge Barrier To An Effective Schizophrenia Medicine
For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant schizophrenia, and the only one it recognizes as reducing the risk of suicide. This has made it very difficult for doctors and patients to take advantage of the medicine. But that's about to change.
As Josh Bloom and I wrote last November, the Food and Drug Administration (FDA) imposed onerous requirements on health care providers prescribing the effective drug clozapine to patients with treatment-resistant schizophrenia.
Clozapine is an "atypical" antipsychotic drug. Atypical antipsychotic drugs have fewer movement-related side effects—like tardive dyskinesia, tremors, and stiffness—than "typical" psychotic drugs. The FDA approved clozapine for treatment-resistant schizophrenia in 1990, and in 2002, the agency announced that clozapine reduced the incidence of suicide in people with schizophrenia and other mental illnesses. A 2024 study by Brazilian researchers found that people prescribed atypical antipsychotics other than clozapine had a 21 percent greater chance of death than those prescribed clozapine. The World Health Organization includes clozapine on its List of Essential Medicines.
Up to 20 percent of homeless people have schizophrenia, and clozapine might help them turn their lives around. Unfortunately, the FDA has required clinicians, pharmacists, and patients to comply with onerous, one-size-fits-all rules. These rules help explain why, with an estimated 30 percent of schizophrenic patients not responding to first-line antipsychotic drugs, clozapine is only prescribed to 4 percent of schizophrenic patients in the US.
The reason behind the FDA prescribing restrictions has to do with a clozapine side-effect occurring in less than three percent of patients: agranulocytosis, a reversible but life-threatening drop in the white blood cell count. The risk of agranulocytosis drops sharply within months of beginning treatment. Research shows that, within a year, the risk of blood abnormalities caused by clozapine is similar to that of other antipsychotic drugs for which the FDA does not impose onerous prescribing regulations.
When the FDA approved clozapine, it required prescribers to conduct weekly blood tests to screen for agranulocytosis. In 2007, the FDA established the Risk Evaluation and Mitigation Strategy (REMS) program to ensure safety measures for drugs with specific side effects. In 2015, the FDA included clozapine in the REMS program. The Clozapine REMS program mandates that patients undergo routine lab tests, which prescribers and pharmacies must review before approving a limited seven-day supply. These stringent requirements, challenging even for healthy individuals, have made doctors hesitant to prescribe, pharmacies reluctant to dispense, and patients less likely to obtain clozapine.
The REMS program is a rigid, cookie-cutter system that prevents physicians from using their clinical judgment in collaboration with patients' informed consent. Government-mandated REMS programs are unnecessary. Once the FDA approves a drug, manufacturers already track it for unforeseen long-term risks, driven by both regulatory requirements and concerns over reputation and liability. Likewise, doctors routinely monitor patients when prescribing medications with potentially serious side effects—failing to do so would be malpractice.
Statins, though commonly prescribed, can occasionally cause liver issues. Physicians typically check for this, especially in new patients, and adjust monitoring as needed. Many other medications, including antipsychotics like Seroquel, also carry risks of severe blood abnormalities. Yet, unlike clozapine, Seroquel is not subject to a rigid, bureaucratic oversight program that complicates access to treatment.
The FDA's REMS program exemplifies government overreach, restricting adults' autonomy and right to self-medicate—a topic I explore in my forthcoming book, Your Body, Your Health Care.
Angry Moms, an activist group representing caregivers to patients with treatment-resistant schizophrenia, has been calling on the FDA to remove the Clozapine REMS for years.
Finally, on February 24, 2025, the FDA announced:
Beginning today, FDA does not expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. FDA still recommends that prescribers monitor patients' ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings.
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. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine. FDA has notified the manufacturers that the clozapine REMS must be eliminated. FDA has instructed the clozapine manufacturers to formally submit a modification to eliminate the Clozapine REMS and to update the prescribing information, including removing mandatory reporting of ANC blood tests to the REMS program.
In the coming months, FDA will work with the clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS.
This decision should make it easier for clinicians to treat their patients with a drug with a 35-year track record of effectiveness. Hopefully, many more patients with treatment-resistant schizophrenia will now get help.
Next, the FDA should eliminate the REMS program altogether and allow patients to make their own health care choices in consultation with their chosen clinicians.
#Reprinted with permission. Dr. Singer's original post can be read here.
FDA Makes Access To Clozapine Easier For Patients With Schizophrenia
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