Please Help Us: Clozapine Culture Shift
- The Angry Moms
- Apr 25
- 5 min read
It has been two months since the FDA’s announcement to end the clozapine REMS. Our behavioral health systems were not ready for this change. Clozapine is still being rationed, and doses are still being withheld contingent on routine bloodwork. A major cultural shift is needed surrounding clozapine and the psychiatric treatment of psychosis spectrum disorders. We estimate this will take years.
On April 7th, 2025, an Arizona patient was admitted to a psychiatric hospital where clozapine was held for more than 24 hours upon admission pending the results of a new ANC test. Despite an outpatient medication report confirming the patient to be on a stable dose of clozapine and no signs of adverse effects, the inpatient pharmacist released all the medications prescribed by the admitting psychiatrist - except clozapine. The pharmacist insisted that even though the REMS was gone, “patients still need to test before we can give them clozapine.”
On April 11th, 2025, the mother of a Massachusetts patient was told that if her son was not “adherent with his labs” by the following Monday, “he will have to stop the Clozaril.” This patient was in a hospital recovering from severe paranoia that resurfaced after 4 days without his clozapine. His symptoms caused him to start refusing routine bloodwork. No signs of clozapine adverse effects were present. His only symptoms were from his illness. This patient’s mother testified at the November 2024 FDA advisory committee hearing about losing three immediate family members to suicide, and how her son had failed multiple antipsychotic trials over nearly two decades before any psychiatrist mentioned clozapine, which ultimately produced a miraculous recovery. As promised, her son’s clozapine was discontinued the following Monday - until he finally agreed to the routine blood tests several days later. By then, he was terrified.
On April 18th, 2025, The Angry Moms received a notice from an Oregon family stating, “Local pharmacy continues to follow pre-February 24th FDA guidance. We will run out on Monday over a long weekend. Sad.”
Our community has heard from many families expressing relief that they are now encountering fewer obstacles to accessing clozapine prescriptions since the FDA’s announcement to end the clozapine REMS. We have also received an equal number of reports that patients and families continue to face tremendous systemic and cultural barriers.
Changes to clozapine procedures are new for everyone and there are lingering questions to be answered. No outpatient or hospital pharmacy should be withholding clozapine for the purpose of obtaining a routine ANC test or pending the results thereof. The results of ANC testing are not required to dispense clozapine, and pharmacists should not be asking for lab results or requiring ANC data as a requirement to dispense clozapine. Pharmacists are no longer in the decision chain. All treatment decisions involving ANC testing or administering clozapine are at the discretion of the prescribing provider. While the clozapine label still states that testing of ANC at regular intervals is required, the testing is no longer mandatory to dispense the drug, and pharmacists have been instructed to fill any active clozapine prescription.
The American Association of Psychiatric Pharmacists recently published this notice, which was distributed to pharmacists by the National Association of Boards of Pharmacy on April 2nd, 2025:
Here are some highlights from this notice:
The FDA REMS decision is intended to improve access to clozapine and reduces the risk of the dangerous treatment interruptions that have resulted in many patients relapsing into psychosis, suicidality, hospitalization and even death.
Many of these treatment interruptions occurred during pharmacy dispensing due to corporate policies regarding clozapine.
As a result of the REMS removal, pharmacies do not need special dispensing authorization to fill clozapine prescriptions. An important part of FDA’s decision was based on the significant and potentially dangerous barriers patients encounter when their prescriptions are filled by the pharmacy.
“We urge… Clinics, hospitals and mail order and community pharmacies to immediately change their operating procedures to remove all requirements related to clozapine dispensing and audit criteria that were part of the now-defunct REMS elements. These elements include quantity limits, copies of lab results and REMS Dispensing Authorizations.”
A key driver toward ending the REMS was to prevent abrupt interruptions in clozapine treatment. The clozapine package insert instructs that patients discontinuing clozapine should “Reduce the dose gradually over a period of 1 to 2 weeks,” and to “Monitor all patients carefully for the recurrence of psychotic symptoms and symptoms related to cholinergic rebound such as profuse sweating, headache, nausea, vomiting, and diarrhea.” In The Clozapine Handbook by Dr. Jonathan Meyer and Dr. Stephen Stahl, an entire chapter titled “Discontinuing Clozapine and Management of Cholinergic Rebound” outlines aggressive strategies to manage cholinergic rebound and rebound psychosis. Intervention should begin within 24 hours.
Under the clozapine label’s instructions for re-initiating clozapine treatment, the guidance states, “When restarting clozapine tablets in patients who have had even a brief interruption in treatment with clozapine dosage must be reduced. This is necessary to minimize the risk of hypotension, bradycardia, and syncope… If one day’s dosing has been missed, resume treatment at 40% to 50% of the established dose. If two days dosing have been missed, resume dose at approximately 25% of the established dosage.”
Abrupt clozapine interruptions are serious, as are the subsequent re-initiations. If done improperly, the result can be a “black box event” given clozapine’s boxed warnings for orthostasis, bradycardia, and syncope. Unless there is a compelling and presenting serious adverse effect that necessitates abruptly stopping the clozapine, discontinuations should be handled slowly over time with the prescriber. Being overdue for a routine ANC test, absent symptoms of agranulocytosis, is not a reason to abruptly stop clozapine.
Even when the clozapine REMS was in place, outpatient clinics, hospitals, pharmacies and providers frequently enacted "stricter" policies than the REMS required – falsely believing such measures would improve patient safety. Such policies instead cause far more harm.
For The Angry Moms, our disappointment points to a far more sinister truth. For more than three decades it has been acceptable to torture schizophrenia patients by withholding clozapine without cause, for the purpose of a routine blood test. A test for a treatable condition that only affects 1 in 250 clozapine patients and rarely occurs after the first six months of clozapine treatment. The end of the clozapine REMS is intended to end this practice.
We need everyone’s help to end the systemic discrimination our families and loved ones have faced. Now, more than ever, we need strong leadership and advocacy to help amplify our voice and devise a plan to end all this unnecessary suffering.
Will you help us lead the way?
The Angry Moms
Our PNP still insists that Genoa won’t fill a 30 day supply despite the rems removal and her not changing my LO’s dose. This is keeping us homebound because he can’t get enough of his medication to go away for a much needed vacation. I think it’s his provider who is afraid to try to write for 30 days. She says she reads everything iI share with her about the change in requirements, but if she does, she’s still locked into her old thinking. A shift certainly needs to happen if we want clozapine to even benefit our LOs
My son died due to his psychosic symptoms from resistant schizophrenia- schizoaffective disorder- I begged for the doctors to try clozapine - and no one would- after many hospitalization and homelessness- missing and incarceration- my son passed away deep in psychosis.
Amazing! Not in a good way way. I applaud all of the medical providers and pharmacists who are removing these barriers to access to clozapine. But the serious, life and death possibility of missed doses and potential harm for cold turkey discontinuation does not go away just because the REMS is abolished. FDA, where is the coordinated leadership to dismantle barriers, begun with the REMS change, to eliminate procedural harms inherent in the current clozapine system?
I want to applaud Walmart Pharmacy for immediately complying with the discontinued ANC requirement. Our pharmacist said no blood work required and offered to dispense both remaining months if insurance agreed. The insurance agreed to cover all months at once. What a blessing to our family whom have been dealing with this “no blood, no drug” nightmare for 15 years! I agree that doctors are going to be fearful, especially if they’re in a democrat-run states. Massachusetts is a frightening example of losing your rights and freedoms. The doctors need to feel safe enough to reduce ANC checks without fear of losing their license. Until the recommendations are made clear for doctors, the only option for those still suffering under…
Until they change the guidelines to the Dr they are hesitant to change lab work request. The doctors do not want to be held liable for not following the guidelines. More change is needed to get to access is smooth and fluid.