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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. [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.
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 (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.
The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for adults to treat moderate to severe acute pain. The drug, called Journavx ...
The atypical antipsychotic clozapine has also been suggested as an alternative antipsychotic for patients experiencing tardive dyskinesia. [9] Tardive dyskinesia may reverse upon discontinuation of the offending agent or it may be irreversible, withdrawal may also make tardive dyskinesia more severe. [10]
"ACS develops guidelines for cancer screening and prevention, informed by the latest available data and evidence, to meet the needs of clinicians, the general public, and policy," he said.
Toby Fischer lives in South Dakota, where just 27 doctors are certified to prescribe buprenorphine -- a medication that blunts the symptoms of withdrawal from heroin and opioid painkillers. A Huffington Post analysis of government data found nearly half of all counties in America don't have such a certified physician. So every month, Fischer and his mother drive to Colorado to pick up their ...