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Call to Action: Blast the FDA

We are launching a campaign to “Blast the FDA” with complaint letters directed to the clozapine REMS division. Please create a 1-page “Dear FDA” letter that briefly describes the harm you have experienced, directly or indirectly, due to the clozapine REMS platform, unnecessary excessive blood tests, lack of clozapine access, and prescriber hesitancy.


Include symptoms, injuries and any dangerous situations that occurred because of discontinuing or interrupting clozapine, or from failing to use clozapine when indicated. A letter from a real-life member of The Angry Mom’s is included at the end of these instructions. Feel free to borrow content from this example, and please share a brief example from your own experience of patient harm in the blog comments.


The FDA needs to hear us!


Address:


U.S. Food & Drug Administration

ATTN: FDA Clozapine REMS

10903 New Hampshire Avenue

Silver spring, MD 20993


Some key points to include in your letter:

  • Doctors calling clozapine “a last resort,” or clozapine was never offered.

  • Doctors saying there is a “high risk of neutropenia” with clozapine - the risk is less than 1% (only 0.23%) and cases are rarely fatal (97% survive).

  • Doctors prescribing more than two other antipsychotics, or long delays (months/years/decades) without a clozapine trial.

  • Can’t find a doctor or a pharmacy that is certified in the REMS.

  • Can’t find a doctor willing to use clozapine, including after hospital discharge.

  • Hospitals initiating clozapine, but outpatient prescribers transition to other medications after discharge due to clozapine's inconvenience.

  • Any interrupted clozapine refill, regardless of the reason (even if the interruption was covered with extra medication).

  • Being forced to stockpile medication to cover interruptions.

  • “Patient blaming” for delayed labs, phlebotomy problems, or pharmacist confusion.

  • Refusing to administer clozapine without an ANC test if the patient cannot participate in, or consent to blood draws.

  • Doctors refusing to waive missing labs because of patient refusal or logistical issues.

  • Hospitals delaying clozapine because they don’t stock it in the onsite pharmacy.

  • Hospitals delaying clozapine because of standard policy to re-verify blood tests.

  • Failing to use clozapine in jails or prison.

  • Doctors engaging in “forced” blood draws (using restraints) instead of waiving blood tests before administering clozapine.

  • Clozapine being stopped or discontinued for mild neutropenia or non-clozapine related conditions (clozapine should not be stopped except in cases of ANC falling below 500/uL, confirmed with an immediate re-test, and no other explainable cause, i.e. chemotherapy).

  • Doctors showing exaggerated concern and hyper-awareness of neutropenia yet neglecting other side effects.


An anonymous member of The Angry Mom’s shares her letter here:


Dear FDA,


The clozapine REMS program has caused harm to my son. The harm has taken many forms.


At age 18 he developed schizophrenia. The symptoms were dangerous and disabling. For one year he was prescribed 4 different antipsychotics that did not work very well and caused movement disorders.


Not one psychiatrist mentioned clozapine – I had to ask.


The 1st doctor said, “Clozapine is very dangerous and is only given as a last resort”

(NOT TRUE)

The 2nd doctor said “We are not certified, we don’t do clozapine here”

(DISCRIMINATORY)

The 3rd doctor said, “You don’t need clozapine, we have newer better meds now”

(NOT TRUE)

The 4th doctor said, “We can’t do clozapine if there is a history of noncompliance”

(WRONG)

The 5th doctor FINALLY agreed to use clozapine – she is two hours away.

(SAD)


Each statement listed above represents misinformation, inappropriate prescriber hesitancy and a severe lack of access to clozapine. This is caused by the burdensome blood tests, rigid REMS requirements and risky REMS program that is far more likely to cause dangerous interruptions in treatment than to prevent a neutropenia death. Doctors have become hyper-concerned about neutropenia, avoidant of clozapine at all costs, and rigidly unwilling to waive blood tests or initiate clozapine at all, even in dangerous patients.


Following the 11/15/21 REMS agency conversion, my son’s clozapine was interrupted. Calls to the REMS hotline were returned 4 days later. The root cause was MULTIPLE levels of failure associated with a careless and unvalidated system conversion.


We have had numerous blocked refills associated with lab delays, unsigned PSF’s, pharmacist confusion with the platform, pharmacist confusion with the “additional enforcement discretion” announcement, and one time, after 3 years on clozapine, my son was 2 weeks late getting his monthly test.


NOT ONCE has he developed severe, or even mild, neutropenia. For my son’s safety and for our family’s safety, I have been forced to procure a stockpile to use during interruptions. I have had no choice.


Lastly... In the fight to keep my son (and our family) both safe and alive, I have been labeled a “difficult customer” at the pharmacy. We have had to accept blame – for system errors, delays, and absurdities like not knowing the “REMS ID” (a parameter we had never heard of).


And the punishment has been to have lifesaving medication withheld from my seriously ill child.


Please fix the clozapine REMS and stop the pharmacies from blocking vital medication refills. Please educate doctors and hold them accountable to use clozapine when indicated. We have suffered enough.


Sincerely,


An Angry Mom




40 Kommentare


Gast
02. Juli 2023

July 1, 2023

Dear FDA,

My son has been diagnosed with Schizophrenia and is considered “Treatment Resistant” in that he has tried many different anti-psychotics including Invega, Risperdal, Olanzapine, Vraylar, Abilify, Prolixin, Fluphenazine, Haldol, Seroquel, Thorazine, among others), suffering psychosis for 4 years before ever being given Clozapine. No doctor ever mentioned Clozapine from onset of his illness in 2018 in the Arkansas State Hospital to 2019-2021 in the Montana State Hospital about 8 times, many shorts stays, then released unstable, then relapses in and out of local hospitals, transferred to the Montana State Hospital about 8 times in 3 years, 2019 to 2021.

I performed my own online research and found Clozapine in 2021 on the internet, learning that…

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Gast
01. Juli 2023

I also had my son, husband, sister and mom send letters regarding my daughter.

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Gast
30. Juni 2023

Yes this practice is unforgivable!!!!!

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Gast
29. Juni 2023

U.S. Food & Drug Administration

ATTN: FDA Clozapine REMS

10903 New Hampshire Avenue

Silver spring, MD 20993

To Whom it May concern,

I’m a mother and caregiver for my 39-year-old son with schizophrenia. He’s been on clozapine for 3 years now.

After 15 years on the wrong antipsychotics, he finally was given a trial of clozapine. Within 3 days, the auditory hallucinations and delusions stopped, and his psychosis was finally under control. His outpatient psychiatrist had labeled his case “end stage”. He was “in treatment” and on antipsychotics, but they weren’t working. He was hospitalized in severe psychosis weighing 125lbs at 6’4”. I thought my only hope was long term care in a state hospital. The inpatient psychiatrist asked …


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Gast
30. Juni 2023
Antwort an

I am so sorry for all you and your family have been through and hope sharing your experience spares others from the same fate.

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Gast
25. Juni 2023

Sending my letter tomorrow: June 26, 2023


To: U.S. Food & Drug Administration

Attn: FDA Clozapine REMS

10903 New Hampshire Ave.

Silver Spring, MD 20993


Please allow quicker and easier access to clozapine, the most effective anti-psychotic medication and the only one FDA-approved for treatment-resistant schizophrenia and for reducing suicide in those patients. My son takes clozapine, and it is the only medication that has provided him with relief from agitation and severe anxiety, symptoms of schizophrenia and schizoaffective disorder.


Fortunately, my son’s psychiatrist understands the value and efficacy of clozapine. Sadly, over 80% of US patients with treatment-resistant schizophrenia (or schizoaffective disorder) never receive this vital medication, which may be their only chance for relief from acute symptoms.


The…


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Gast
30. Juni 2023
Antwort an

Thank you for your advocacy

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