Our “Negligence” Emails Make National News

Every week since April 2024, The Angry Moms has published emails titled “Clozapine REMS – Negligence of the Week” with heartbreaking highlights from submissions to our website and social media outlets.

Senior reporter Mark Moran has published a story on our “Negligence” emails and our efforts to end the clozapine REMS in the October 2024 edition of Psychiatric News. Read his article here:

Patient Advocacy Groups Demand Significant Changes to Clozapine REMS | Psychiatric News (psychiatryonline.org)

Thank you, Mark, for publicizing our struggles. Thank you to Dr. Robert Laitman and Dr. Robert Cotes for contributing to the publication and for acknowledging the plight of The Angry Moms.

Our “Negligence” reports are certainly biased and skewed. Our community represents a very small subset of the schizophrenia and psychosis population who are capable of connecting to websites and verbalizing problems. Our stories and vignettes are limited to those with engaged and connected caregivers willing to research, willing to drive, make phone calls, chase down lab orders, argue with pharmacists, and make frequent calls to the REMS hotline. These are families and agencies willing to fight to keep their family members and patients on uninterrupted clozapine treatment.

The reality is far worse than our “Negligence” emails. Most individuals with these illnesses are too cognitively impaired or disenfranchised to recognize medical negligence is happening. Such patients are wrongly interrupted, wrongly discontinued, or worse – refused clozapine treatment in the first place. Many such individuals have died and cannot share their story of negligence. The FDA does not track or record these regulation-induced adverse events.

As far as we know, The Angry Moms is the only group reporting such events. Incredibly, this task has fallen on exhausted and unpaid mothers to figure out, rather than agencies and corporations professionally tasked with monitoring psychiatric medications and treatment.

The Angry Moms has encountered a handful of true cases of clozapine-induced neutropenia (most alleged cases have been “false positives” or unrelated to clozapine). These few instances were indeed serious life-threatening events. But NOT ONE of these cases averted severe illness or death because someone pulled up to a pharmacy window and the pharmacist refused to dispense clozapine because the REMS had blocked a refill. In each case, either the patient had become ill, or a clinician intervened upon receipt of the laboratory report.

The REMS appears to be exclusively blocking prescription refills for individuals who do not have clozapine-induced severe neutropenia. Please reach out to The Angry Moms and tell us if you have experienced a true case of severe neutropenia, confirmed associated with clozapine, that was first detected, thereby saving a life, because the clozapine REMS specifically blocked a dispense authorization and a pharmacy refused to fill the prescription. We have yet to encounter a single clozapine REMS victory.

Clozapine patients should be monitored carefully, for all potential clozapine-related side effects, with as close to weekly ANC measurements as possible during the first 18 weeks of treatment. Unless, of course, the testing itself presents a barrier to treatment. The risk of developing severe neutropenia is only 1 in 250 clozapine patients. The condition is rarely fatal, ultimately leading to less than 5 deaths in 10,000 clozapine patients. On the other hand, the likelihood of death or severe consequences from untreated psychosis or recurrent suicidal behavior without clozapine treatment is several hundred times higher.

For a detailed summary of this research, refer to our 9/26 petition to make safety revisions to the clozapine product label and to end the clozapine REMS. Please sign and share: 

www.change.org/EndtheclozapineREMS

There are humane ways to track and monitor patients: finger-stick ANC devices, frequent clinical visits, and checking for fever, signs of infection, and overall wellness. A skilled provider and strong patient support are essential.

Clozapine patients and their families are held hostage by an outdated product label and regulatory barriers that are outright cruel. The clozapine REMS is intended to be a patient “safety program.” It is not. It is a health hazard that must be eliminated.

The Angry Moms