The Psychiatric Times published an article about the large majority of FDA committee members recently voting to dismiss the Risk Evaluation and Mitigation Strategy (REMS) for clozapine.
That reminded me of my short post about Cobenfy, a new drug for schizophrenia. It has side effects but none of which necessitate the need for a REMS program. If you do a web search for information on Cobenfy and REMS, you can ignore the Artificial Intelligence (AI) Gemini notification at the top of the Google Chrome search page saying that “Cobenfy…is subject to a REMS (Risk Evaluation and Mitigation Strategy) due to potential side effects like urinary retention.” That’s not true.
It was yet another AI hallucination triggered by my internet search. I didn’t ask Gemini to stick its nose in my search, but it did anyway. Apparently, I don’t have a choice in the matter.
Anyway, the FDA vote to get rid of REMS for clozapine also rang a bell for me of the incredibly difficult and tedious process that the clozapine REMS registration process caused in 2015 when it was first initiated. I spent lot of time on hold with the REMS center (I think it was in Arizona) trying to get registered. A few people in my department seemed to have little problem with it, but it was an ongoing headache for many of us.
Then after getting registered, I started getting notified of outpatients on clozapine getting added to my own REMS registry list. The problem is that I was a general hospital consultation-liaison psychiatrist only—I didn’t have time see outpatients.
I think I called REMS on more than one occasion to have outpatients removed from my REMS list. I suspect they were added because their psychiatrists in the community were not registering with REMS. And then in 2021, the FDA required everyone to register again. By then, I was already retired.
Other challenges were occasional misunderstandings between the psychiatric consultant and med-surg doctors about how to manage medically hospitalized patients who were taking clozapine, or brainstorming about how to fix medical problems caused by clozapine itself. Sometimes it was connected to things like lab monitoring for absolute neutrophil counts or restarting clozapine in a timely fashion after admission or following surgeries, or trying to discharge them to facilities which lacked the resources for adequate monitoring of clozapine.
Arguably, these are probably not absolute reasons for shutting down the REMS registry. They’re more like problems with how the program is run, such as “with a punitive and technocratic approach” as expressed by one FDA committee member.
Committee members also thought psychiatrists should be allowed to be doctors, managing both the medical and psychiatric aspects of patient care.
On the other hand, some might argue that those are reasons why consultation-liaison psychiatry and medical-psychiatry training programs exist.
I’m not sure whether the clozapine registry will go away. I hope that it can be streamlined and made less “punitive and technocratic.”
Go Retire Psychiatrist 