It will be interesting and maybe a bit scary to see how an FDA decision to remove the requirement for risk evaluation and mitigation strategies (REMS) in clozapine use, which varies by country, works out in Texas and other U.S. states with weaker public health services. Is the superiority of clozapine at all related to REMS monitoring itself, which may increase patient compliance? I don’t know.
Experts who supported the decision to remove REMS obviously know far more than I do as a novice caregiver. But, I do know from listening that expert positions on the risks and benefits of other medications have varied considerably over the years. And, I know the parents of two young patients who died suddenly while using clozapine, though I do not know if clozapine was the cause.
Mostly, I fear Mental Health America’s (MHA) ranking of Texas as 50th in accessibility of mental healthcare services may point to an elevated risk for Texas patients not being adequately monitored while using clozapine, especially in the early days of use. In addition to the risk of neutropenia, there are risks of cardiomyopathy and arrhythmias that increase when patients discontinue and restart their medications, as those without adequate support are known to do. Some patients are inconsistent in taking medication without even realizing it. I hope the FDA took such risks into consideration.
#REMS #Schizophrenia #Clozapine #Psychiatry #Pharmacology #Medicine
https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine
