Posted on 02/28/2025 9:43:31 AM PST by sopo
FDA no longer expects prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategy (REMS) program for the antipsychotic clozapine, Following the advice of a nearly unanimous joint FDA advisory committeeopens in a new tab or window, the agency decided that clozapine's REMS program is no longer necessary to ensure that the benefits of the drug outweigh the risk for severe neutropenia. The highly anticipated moveopens in a new tab or window will expand access to clozapine, which is the only drug indicated for treatment-resistant schizophrenia. It's also used in patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.
"Eliminating the REMS is expected to decrease the burden on the healthcare delivery system and improve access to clozapine," the FDA said in its statement.
As part of the overhaul, prescribers will no longer be required to report the results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine to patients. However, prescribers are still encouraged to monitor patients' ANC levels according to what is outlined in the label's prescribing information.
The risk for severe neutropenia (ANC count less than 500 cells/uL) still exists, and will still be listed within the boxed warning on all clozapine products. Severe neutropenia, which is associated with an increased risk of serious and potentially fatal infections, occurs in a small percentage of patients taking clozapine.
Previously, the REMS program required patients to undergo weekly blood draws in the first 6 months of treatment, graduating to blood draws every 2 weeks until month 12, and monthly draws thereafter. Prescribers had to document a patient's ANC by fax or the web-based REMS system, which then authorized the REMS-registered pharmacy to dispense clozapine. Prescribers and pharmacy staff were also required to complete training to become certified to prescribe and dispense clozapine.
(Excerpt) Read more at medpagetoday.com ...
Whatever. Psych patients on these drugs will still have brain damage and shoot up the workplaces. That’s what psychiatry does.
This was a DEI decision.
Out several months ago.
Felt that certain people were not getting the drug because they wouldn’t follow testing protocols.
So removing testing protocols would “lower the barrier to access “.
People on clozapine are pretty psychiatricly compromised.
And they cannot always tell if they are sick.
Sorry , late. You have your facts wrong. The date on it is February 24, 2025.
So?
DEI is alive and well and functioning in many parts of government
Yes,so is DOGE, which was my point, peace.
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