The FDA has made a historic decision to end the clozapine REMS program, effective immediately.
To read the official FDA announcement, click HERE.
Heidi Anne Duerr with Psychiatric Times has published a more detailed announcement:
The FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. However, the FDA does not expect prescribers, pharmacies, and patients to participate in the REMS program or to report results of ANC blood tests before pharmacies dispense clozapine.
We will communicate additional information as it becomes available.
Thank you to Schizophrenia & Psychosis Action Alliance, Team Daniel Running for Recovery from Mental Illness, Dr. Gil Honigfeld, and many other physicians, agencies and advocacy groups that have supported this mission.
Above all, thank you to our heroes and survivors who bravely and publicly shared their hardships accessing clozapine with the entire world.
The Angry Moms
In India, as in many other countries in the world, they ANC test only once per year. Stop the fear mongering in the USA that monthly testing is required! Its also an unnecessary financial drain on Medicare and health insurance (is there a money-making incentive here?) and is 99.9% of no help to the patient. The ruling states the testing is only RECOMMENDED so we must stand on this recommendation idea and encourage American doctors to do the right thing!
While I am grateful that REMS is out of the loop for clozapine, there should not be any monthly blood testing required by doctors for a patient on clozapine more than 2 years. If a doctor wants to do a yearly ANC test, that is in line with the yearly bloodwork many people get. But what should be being done is training clozapine patients what to be aware of regarding side effects from clozapine, and when to get to their doctor or ER should they suspect a problem.
I appreciate all the effort and personal investment that went into making the REMS go away. But I am personally very disappointed that we are still left with monthly blood monitoring for life. Monthly blood testing didn't burden us a great deal initially, as we were so glad to have such an effective medicine on board and it was a lot better than weekly blood testing--but I can assure you that after nearly 19 years of doing it (with no neutropenia ever) monthly blood testing is a significant burden. Now that more people will be getting this drug (hopefully) and staying on it longer, monthly blood draws for life will be a widely shared burden. But I honestly feel qu…
This is such great news!! Thank you Rachel, Angry Moms, Arizona Mad Moms, Team Daniel, S&PAA, TAC, CURESZ and everyone who tenaciously advocated and persevered to make this happen! My family and I are so grateful!
This is the best news today!!! Thank you Rachel, Angry Moms, Arizona Mad Moms, Team Daniel, S&PAA, TAC, CURESZ, and many more for working diligently to succeed in the FDA hearing on November 19, 2024 - our SMI loved ones can only get better! God bless you all!!!