Breaking: FDA Announces End of Clozapine REMS!
Link to FDA Site Click HERE.
Dr. Gil Honigfeld, "The Godfather of Clozapine," in 1990
HOPE For A New Beginning
We are mothers, parents, family members and caregivers who have connected through various support groups and social media. We have come together to advocate for the safe use of clozapine for our loved ones with psychiatric conditions. For 30 years troublesome regulations imposed by the US Food and Drug Administration (FDA) blocked access to this life-saving medication. Our loved ones suffered grave torment, injury, disability, and death caused by the FDA’s discriminatory and neglectful restrictions for dispensing clozapine. To summarize: We Got Angry.
Clozapine is among the safest and most effective antipsychotic medications. It is the ONLY drug FDA-approved for treatment-resistant schizophrenia (TRS) and for reducing suicide in psychosis disorders. But over 80% of US patients with TRS never receive this vital medication. Clozapine utilization in the US is lower than many undeveloped countries.
On November 19th, 2024, a hundred "Angry Moms" appeared at an FDA advisory committee hearing wearing T-shirts that read, "CLOZAPINE is the SAFEST Antipsychotic in the WORLD." More than a dozen family members shared tragic testimonies of the FDA's clozapine Risk Evaluation and Mitigation (REMS) program causing treatment interruptions and preventing lifesaving treatment. More than 4,000 supporters signed our FDA petition. On February 24th, 2025, the FDA announced the historic decision to end the program, which was finally dismantled on June 13th, 2025. This was a historic victory for mothers of individuals with Serious Mental Illness (SMI). Our new mission is to improve care and treatment for individuals with SMI, including schizophrenia and psychosis disorders.
The REMS application and associated clozapine restrictions persisted for more than three decades. Other psychiatric medications have comparable neutropenia risks, and certain cancer medications have 10 to 100 times higher risks of severe neutropenia compared to clozapine. But no other medications ever required frequent blood tests or REMS programs to block prescriptions. The discrimination against clozapine patients has been devastating.
The clozapine REMS program directly and indirectly caused thousands of deaths. Many individuals were denied access to the only treatment for their condition. These gravely ill individuals (and their families) needlessly endured severe suffering, repeated hospitalizations, incarcerations and death. The burden of routine testing and ongoing problems with the REMS caused a deadly epidemic of "Clozaphobia" - an irrational fear of prescribing clozapine and an ongoing shortage of experienced doctors willing to prescribe it.
