Tag: treatment resistant schizophrenia

FDA Has Yet to Decide on What to Do About the Clozapine REMS Program

I checked on what the FDA is doing about changing or closing down the Clozapine REMS program. It doesn’t look like they’ve taken any action yet. Recall there was a Clozapine REMS Advisory Committee meeting about this on November 19, 2024 that I posted about recently. The upshot was that the committee voted overwhelmingly (14 yes to 1 No) to get rid of the Clozapine REMS program.

What I didn’t realize until today was that a former colleague of mine was a member of the committee. Dr. Jess Fiedorowicz, MD, PhD was on staff at The University of Iowa Health Care in the past and is now head of the Dept of Mental Health at The Ottawa Hospital in Ottawa, Ontario in Canada. I’ve included the YouTube video below of the meeting and you can find Dr. Fiedorowicz’s remarks via Zoom video at around the 8:05 or so mark into the meeting. You can view his vote to shut down the REMS program at around 8:33.

I also found out about a group called The Angry Moms (those who care for family members on clozapine) who are focused on stopping the Clozapine REMS program and one of their web pages makes it pretty clear they’re not happy that the FDA has not made a decision about REMS yet.

They mention Dr. Gil Honigfeld, PhD who I’d never heard of until now. You can tell from his T-shirt how he feels about clozapine. He has been called the “Godfather of Clozapine” and his opinion about the REMS program along with a short history of clozapine can be found at this link.

I don’t know what the FDA will do about the Advisory Committee’s recommendation, but I hope they do it soon.

Amaryllis Progress and Other Notes

I have a few messages to pass on today. This is the last day of November and the Amaryllis plants are doing so well Sena had to brace the tallest one using a Christmas tree stake and a couple of zip ties. It’s over two feet tall!

I’m not sure what to make of almost a dozen comments on my post “What Happened to Miracle Whip?” Apparently, a lot of people feel the same way I do about the change in taste of the spread. So, maybe it’s not just that my taste buds are old and worn out.

Congratulations to the Iowa Hawkeye Football team last night! They won against Nebraska by a field goal in the last 3 seconds of the game. I had to chuckle over the apparent difficulty the kicker had in answering a reporter’s question, which was basically “How did you do it?” There are just some things you can’t describe in words. There’s even a news story about how thinking doesn’t always have to be tied to language.

Along those lines, there might be no words for what I expect to think of tonight’s 1958 horror film on Svengoolie, “The Crawling Eye.” This movie was called “The Trollenberg Terror” in the United Kingdom version. I can tell you that “Trollenberg” was the name of a fictitious mountain in Switzerland.

I’m not a fan of Jack the Ripper lore, but I like Josh Gates expedition shows, mainly for the tongue in cheek humor. The other night I saw one of them about an author, Sarah Bax Horton, who wrote “One-Armed Jack”). She thought Hyam Hyams was the most likely candidate (of about 200 or so) to be Jack the Ripper, the grisly slasher of Whitechapel back in 1888. He’s a list of previously identified possible suspects. I found a blogger’s 2010 post about him on his site “Saucy Jacky” and it turns out Hyams is one of his top suspects. Hyams was confined to a lunatic asylum in 1890 and maybe it’s coincidental, but the murders of prostitutes stopped after that. I’m not going to speculate about the nature of Hyams’ psychiatric illness.

There’s another Psychiatric Times article about the clozapine REMS (Risk Evaluation and Mitigation Strategies) program. I found a couple of articles on the web about the difficulties helping patients with treatment resistant schizophrenia which I think give a little more texture to the issue:

Farooq S, Choudry A, Cohen D, Naeem F, Ayub M. Barriers to using clozapine in treatment-resistant schizophrenia: systematic review. BJPsych Bull. 2019 Feb;43(1):8-16. doi: 10.1192/bjb.2018.67. Epub 2018 Sep 28. PMID: 30261942; PMCID: PMC6327301.

Haidary HA, Padhy RK. Clozapine. [Updated 2023 Nov 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK535399/

The paper on the barrier to using clozapine by Farooq et al is very interesting and the summary of the barriers begins in the section “Barriers to the use of clozapine in TRS (treatment resistant schizophrenia). I think it gives a much-needed perspective on the complexity involved in managing the disorder.

So what do you think about Miracle Whip?

Clozapine REMS Program May Go Away

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.”