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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Clozapine, sold under the brand name Clozaril among others, is a psychiatric medication and was the first atypical antipsychotic to be discovered. [6] It is primarily used to treat people with schizophrenia and schizoaffective disorder who have had an inadequate response to two other antipsychotics, or who have been unable to tolerate other drugs due to extrapyramidal side effects.
Antipsychotics by class Generic name Brand names Chemical class ATC code Typical antipsychotics; Acepromazine: Atravet, Acezine: phenothiazine: N05AA04
Singer and Bloom acknowledge that the FDA added clozapine to the REMS program in 2015 "because of a rare side effect (less than 3 percent frequency) called agranulocytosis, a reversible but life ...
The fourth Maudsley Prescribing Guidelines International Conference Clinical Psychopharmacology in the time of COVID was held remotely on Wednesday 20th October 2021. Coinciding with publication of the 14th edition, the lead editors of the Guidelines and other key contributors, many of them leaders in their fields, have outlined the evidence ...
Clozapine (Clozaril), an atypical antipsychotic, fell out of favor due to concerns over drug-induced agranulocytosis. Following research indicating its effectiveness in treatment-resistant schizophrenia and the development of an adverse event monitoring system, clozapine re-emerged as a viable antipsychotic.
[149] [150] Clozapine is of benefit to around half of this group although it has the potentially serious side effect of agranulocytosis (lowered white blood cell count) in less than 4% of people. [151] [152] [153] Between 12 and 20 per cent will not respond to clozapine and this group is said to have ultra treatment resistant schizophrenia.
Clozaril – atypical antipsychotic used to treat resistant schizophrenia Concerta ( methylphenidate ) – an extended release form of methylphenidate Contrave ( naltrexone/bupropion ) – a combination drug used in the treatment of mood and psychotic disorders.