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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.
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.
The California Regulatory Notice Register (Notice Register or Z Register) contains notices of proposed regulatory actions by California state agencies to adopt, amend, or repeal regulations contained in the California Code of Regulations (CCR). It is similar to the role of the Federal Register.
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 ...
A number of prominent companies have scaled back or set aside the diversity, equity and inclusion initiatives that much of corporate America endorsed following the protests that accompanied the ...