The US Food and Drug Administration states that “prescribers, pharmacies and patients will participate in the clozapine risk assessment and mitigation strategy (REMS) program or report results from absolute neutrophil count (ANC) blood tests before pharmacies distribute He announced he was not expecting to do so. Clozapine.”1 This will take place on November 20, 2024 after a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Psychopharmacological Drug Advisory Committee. Access barriers.1
In their announcement, the FDA did not completely dismiss the importance of monitoring ANCs, and the organization “still recommends that prescribers monitor ANCs in patients according to the monitoring frequency listed in the prescription information. “It’s,” he added. They also revealed that the regulations information continues to include warnings about severe neutropenia, including existing boxed warnings.
“This is an important day for all affected by schizophrenia who can withstand treatment. It relies on clozapine to allow them to manage symptoms and thrive, and to achieve this. For families who are pursuing, Med, CEO of Schizophrenia & Psychosis Action Alliance; Psychiatric Time In an exclusive interview.
Psychiatric Times Editor-in-Chief John J. Miller, Maryland, repeated his emotions. “This is great news for both patients and prescribers. The FDA’s decision to eliminate clozapine’s REMS protocol will undoubtedly increase the use of schizophrenia patients for multiple reasons,” he said. Psychiatric time. “One of the biggest obstacles for patients who agree to the clozapine trial is the patient’s unwillingness to participate in previously necessary strict absolute neutrophil count lab monitoring. However, informed consent and ANC The importance of surveillance remains an active part of clozapine treatment, and it remains to be seen how this surveillance will evolve.”
Peter J. Weiden, MD, Professor of Psychiatry at SUNY Stony Brook School of Medicine; Psychiatric Times Editors of the Schizophrenia and Psychosis Section agreed. “Terminating REMS does not mean ending monitoring of clozapine side effects. This termination of REM will promote access to clozapine and better use by addressing other important side effects. I hope that I will free up the time and resources I can take,” he said. Psychiatric time.
Wyden added that clinicians should always be aware and monitored of adverse events associated with this agent. “Prescribers should be aware of other clinically serious side effects, such as weight gain, sedation, seizures, and central and peripheral anticholinergic effects,” he explained. “One example is extreme constipation that can lead to complete intestinal obstruction. The time and resources that clinicians would otherwise have gone to REM with continuous use of training and support. I hope to release it.”
Additionally, Weiden expects a decision to help clinicians provide appropriate care to all patients, eliminating “clozapine cancellation disaster due to incorrect interpretation of ANCs in Black patients.” He says that it should be. He said, “One of the reasons for the dramatic ethnic disparities in the use of clozapine comes from the fact that black populations run lower ANCs than white populations, but white populations are of normal and abnormal ANCs. It was used to refer to the results. The rem chain was only strong. It was the weakest link, and often ceases clozapine to reflectively stop clozapine when misinterpreting the normality of clozapine was suddenly stopped as neutropenia or agricultural spherosis.”
The November advisory meeting that led to the decision included testimony from experts such as John Kane of Hofstra/Northwell, The Donald and Barbara Zucker School of Medicine. At the time, Kane told the committee that “clozapine is the cornerstone of the treatment of schizophrenia,” and also stated among his clinical features, including his ability to improve function, reduce mortality and reduce the risk of recurrence. Ta.2 Clozapine also plays an important role in treatment-resistant schizophrenia, he said. Kane details the delay in acquiring clozapine as a result of REMS, noting that the US has lagged its use compared to other countries. “The long-term risk overload is small compared to the benefits of clozapine in outcomes including life expectancy,” Kane told the committee. “Relaxed, long-term monitoring may prefer the benefits of clozapine use without taking the risk of neutropenia.”2
As a result of his testimony, the committee overwhelmingly voted that REMS is no longer appropriate, as only Walter Dunn, PhD, disagrees. Instead of completely removing REM, Dunn, a clinical professor at the school of psychiatry at UCLA David Geffen School of Medicine, and director of the mood disorder clinic at West Los Angeles Veterans Affairs Medical Center, supported surveillance when at risk. It was there. The biggest – presence of the first 18 weeks of treatment.3
Ultimately, the FDA agreed that the benefits of clozapine’s REMS program outweigh the risks of proper patient care, and that “eliminating REMS reduces the burden on health care delivery systems and access to clozapine “We expect this to improve.”1
According to a press release from the FDA, the company is to “officially submit modifications to eliminate clozapine REM and update prescribing information, including removing forced ANC blood test reports to the REMS program.” The FDA will work closely with manufacturers to ensure this.1
Critics of the REMS program have long complained about the hassle and delays in taking medications to patients and the impact these delays have on patients and their families. “As far as it once seemed, the federal REMS program has now become one of the major obstacles that get in the way of patients receiving their medication on time,” wrote Dr. Gilbert Honigfeld. Masu.4 “This is a major factor that limits access to clozapine in individuals with serious mental illnesses that life may depend on. Solve? Eliminate the FDA’s clozapine REMS program and psychiatrists other than others. All medical specialties allow you to practice medicine as well as your peers.”4
What does this mean for prescriber and patient care and how does it develop? Psychiatric Time Continue scope to remain informed to readers. necessarily Subscribe to e-newsletterPlease follow me with s Social Media.
reference
1. Information about clozapine. Latest updates. FDA press release. February 24th, 2025. Accessed on February 25th, 2025. https://www.fda.gov/drugs/postmarket-drug-safety-nformation-patients-and-providers/information-clozapine
2. FDA Advisory Committee meeting Clozapine risk assessment and mitigation strategies. November 19, 2024. Accessed on February 25th, 2025. https://www.fda.gov/media/183655/download
3. Sutter S. Clozapine Rem is a barrier to treatment and is not necessary for safe use, says US FDA Adcomms. Pink sheet. February 25th, 2025. Accessed November 20th, 2024. https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/clozapine-rems-a-barrier-te-treatment-and-unn unnedare-for-safe-us-us-fda – adcomms-say-kdk6icjknbhptbgvffl3c6me7u/
4. Honigfeld G. Clozapine Rems: Regulatory discrimination against psychiatrists? Psychiatric Time. October 3rd, 2024. Accessed on February 25th, 2025. https://www.psychiatrictimes.com/view/clozapine-rems–regulation discrimination-against-psychiatricists
