I have taken clozapine successfully for 17 years. One of my biggest fears in life is reduced access to this life-saving medication. Different people need different medications, and clozapine is not for everyone. Personally, clozapine brought me to full recovery after every other medication I tried both did not eliminate my psychosis and had side effects which left me disabled. On clozapine, 13 years ago, I graduated from college. Today I work and live independently.
Fortunately, I have always been able to access clozapine promptly, though I am aware of countless stories of other people on clozapine who have not been as lucky as I have. Over the last 17 years, I have not missed my clozapine dose one single time—I hope to keep taking it for the rest of my life. It is very easy to become resistant to clozapine. Many people living with schizophrenia who reduce their clozapine or discontinue it, even for a few days, become permanently resistant to the full therapeutic benefits of medication.
In November 2024, the FDA convened an assembly to discuss the necessity of the Risk Evaluation and Mitigation Strategy protocol in monitoring clozapine prescribing. The biggest problem is the massive underutilization of this medication throughout the United States and most of the world. While one in three patients with treatment-resistant psychosis qualify for clozapine, a June 2024 study published in the Journal of Clinical Psychiatry found that only about one in 50 Americans who qualify for clozapine treatment have the opportunity to begin clozapine (1). Why is such an effective medication sometimes called miraculous vastly underutilized? A simple answer is the overly restrictive barriers of the Risk Evaluation and Mitigation Strategy program.
For many years, clinicians have often avoided clozapine because of administrative barriers. They are taught during residency that clozapine is a dangerous medication, and that monitoring is necessary in the best interest of patients. They see no need to question this. Today, even among knowledgeable physicians, there is a prevailing “clozaphobia” associated with prescribing the drug. Many prescribers have never fully understood the burdensome obstacles patients face in getting medication promptly—if they prescribe it at all. Additionally, those who do prescribe clozapine often do so after five to 10 years of persistent untreated psychosis, leading to a poorer outcome.
While every practicing psychiatric nurse practitioner and psychiatrist should routinely prescribe this life-saving medication, many choose not to, which is unfair to severely ill patients with psychosis, who may only respond to clozapine and no other antipsychotic. Those clinicians who do use clozapine often avoid it, though it may be life-saving for treatment-resistant patients and those with suicidality. Providers believe that the patient will never consent to the blood draws even without asking, or fear that working with the Risk Evaluation and Mitigation Strategy is too time-consuming. This severely limits clozapine use.
I hear often from families who have just learned about clozapine and are inclined to believe the medication may likely be fatal for their loved ones. Many are unaware that if their loved one does develop severe neutropenia (which happens less than 1 percent of the time (2,3)) neutropenia can usually be reversed by promptly discontinuing clozapine when blood work reveals a risk and before there is a real possibility of fatality. Death from clozapine use happens in about one in 7700 cases (4).
With clozapine, other problems seem to be overshadowed by the possibility of neutropenia. These include serious conditions such as pneumonia, seizures, myocardiopathy, and constipation. Ileus is common with clozapine and can sometimes even be fatal, or lead to a difficult life with a colostomy, which may be permanent.
At the November meeting of the FDA meeting, a mother came forward and shared how her daughter, who had been thriving for many years as a massage therapist, lost access to clozapine for five days. Following that brief interruption, she lost her apartment and job and began to cycle in and out of hospitals with a treatment-resistant psychosis for several months. Her only option for recovery was clozapine, and after just a five-day discontinuation of the medication, clozapine resistance took away everything she had worked so hard for in her life. According to her mother, she is still acutely psychotic and has found no alternative medication to treat her psychosis.