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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.
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 ...
Clozapine, sold under the brand name Clozaril among others, is a psychiatric medication and was the first atypical antipsychotic to be discovered. [7] It is used primarily 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.
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Isotretinoin carries a high risk of causing severe birth defects if taken during pregnancy [5] (see Teratogenicity of isotretinoin) and the goals of the iPLEDGE REMS (risk evaluation and mitigation strategy) program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin's serious ...
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.
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.
There are 183 in Nevada, 89 in Arkansas and 60 in Iowa. In all of Texas, a state of roughly 27 million people, there are only 1,046 doctors certified to prescribe the medications. Federal stats presented at a June forum showed that out of 625,000 eligible physicians nationwide, only 25,000 are certified to prescribe buprenorphine.