schizophrenia – Go Retire Psychiatrist

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.

I just noticed the FDA announcment of the approval of an antipsychotic with a new mechanism of action for the treatment of schizophrenia.

The drug is Cobenfy and it interacts with cholinergic rather than dopaminergic receptors. It has a number of side effects which are anticholinergic. This could lead to psychotic symptoms that consultation-liaison psychiatrists might get called to evaluate due to the anticholinergic delirium that could occur, which can mimic psychosis.

It’s easy to get alarmed about the Cobenfy side effects. I just remember all of the side effects of the one antipsychotic that has sometimes been the only effective treatment for patients with treatment resistant schizophrenia-clozapine.

Clozapine has been associated with agranulocytosis, seizures, bowel obstruction, prolonged cardiac conduction time leading to arrhythmias, liver toxicity and more. In fact, clinicians are required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program to prescribe it.

Patients who have schizophrenia and take clozapine are often admitted to general hospitals for treatment of medical problems which may or may not be directly related to clozapine itself. This requires close collaboration of internists and surgeons with consultation-liaison psychiatrists.

What do you do for patients who don’t respond to clozapine but are willing to take oral medication? There are augmenting strategies, some of which can be helpful although they could add to the side effect burden.

What do you do for a patient with treatment-resistant schizophrenia who refuses to take oral psychotropic medication? In some cases, it may be necessary to use injections of medications which also can have uncomfortable and even potentially life-threatening side effects. This difficult situation is complicated further by the lack of insight some patients have about their illness and the need for court orders to administer antipsychotics against their wishes.

I hope Cobenfy is a step forward for patients and their families.