TAC is pleased to announce a new blog post in our Research Briefly series, a periodic blog focused on timely research and pertinent information surrounding severe mental illness (SMI), with “The Problem with Clozapine REMS” by renowned clinical psychologist, author, speaker, and subject matter expert on anosognosia, Dr. Xavier Amador.
I have had many patients on Clozapine. It was the first atypical antipsychotic; it was synthesized in 1958 and first used in people in the 1970’s with very good results. Indeed, for patients failing to respond to other antipsychotics it has shown superiority – helping those who could not be helped before. The FDA approved it to specifically help patients who, like my brother Henry, were plagued by suicidal thoughts. And emerging research suggests it may help patients with anosognosia gain insight into their illness!
Despite these advantages, in the early 1990’s I reserved it for patients who had failed two or more trials of other antipsychotic medications. Like many, I took the “fail-first” approach. The reason was a perceived stumbling block — a rare, serious side effect called agranulocytosis (a form of neutropenia) which is reversible when monitored by blood tests, that made many in the USA reluctant to use Clozapine. By the late 1990’s the field became educated about how to handle this problem, and it became a first-line treatment. Fail-first became unnecessary.
But then, just over three years ago, another stumbling block kept the drug from being more widely prescribed despite its clear benefits: The FDA REMS (Risk Evaluation and Mitigation Strategy). Among other things, the REMS required that prescribers and pharmacists obtain certification — as if years of doctoral and post-doctoral training were not sufficient to safely prescribe this life saving (literally) medication. On top of that, all patients taking Clozapine must be enrolled in a centralized patient registry and undergo frequent blood monitoring for signs of neutropenia (once stabilized on Clozapine the REMS require monthly blood tests for the rest of patient’s life!). In my view, these requirements were well-meaning but deeply flawed.
P.S. The next SMI Spotlight episode – a conversation with mental health advocate Lindsay Galvin Rauch, whose family was the subject of the bestselling and critically-acclaimed book "Hidden Valley Road: Inside the Mind of an American Family" and the HBO docuseries "Six Schizophrenic Brothers" – will be released next week. Stay tuned and follow our social media below for updates!
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