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. Troublesome regulations imposed by the US Food and Drug Administration (FDA) have blocked access to this life-saving medication. Our loved ones have suffered grave torment, injury, disability, and death caused by the FDA’s discriminatory and neglectful restrictions for dispensing clozapine. To summarize: We Are 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 third-world countries. Why?
The root cause surrounds frequent neutropenia blood tests mandated by the FDA: weekly for the first six months of clozapine treatment, then biweekly or monthly thereafter. The blood tests are monitored using a Risk Evaluation and Mitigation Strategy (REMS) program. The REMS was implemented to protect patients from clozapine-induced neutropenia, a condition that is treatable, wholly reversible, and unlikely to be fatal. Almost all cases occur during the first 4 months of initiating treatment. The risk of occurrence is less than 1% (about 0.23%) and almost exclusively affects elderly patients. However, most patients initiating clozapine are young adults.
Ironically, the clozapine REMS is endangering patients rather than keeping them safe. In November of 2021 a technical issue erroneously blocked thousands of clozapine prescriptions.
Today, nearly all blocked clozapine refills are because routine labs are missing, delayed, entered incorrectly, or mildly abnormal. Worse yet, severe complications can happen from abruptly stopping clozapine. Problems like cholinergic rebound and breakthrough psychosis usually start within 24 hours. Such complications can become dangerous, even deadly, within a matter of days.
The REMS application for clozapine is both unjustified and discriminatory. Other antipsychotic medications have significantly higher risks of neutropenia in patients under 65, and certain cancer medications have 10 to 100 times higher risks of severe neutropenia compared to clozapine. But none of these other medications mandate frequent blood tests or REMS programs that block prescriptions.
The burden of routine testing and ongoing problems with the REMS have created a shortage of both doctors willing to prescribe clozapine and pharmacies willing to carry it. Additionally, many patients with TRS have mental challenges or logistical barriers that prevent them from participating in frequent blood tests. Such individuals are denied access to the only treatment that may help them. These gravely ill individuals (and their families) needlessly endure severe suffering, often with repeated hospitalizations and incarcerations for years, if not decades.