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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.
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.
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According to the Anxiety and Depression Association of America (ADAA), 6.8 million adults have GAD. Other anxiety disorders include obsessive-compulsive disorder, panic disorder, post-traumatic ...
These side effects are serious and some of them are permanent, and many remain a crucial concern for companies and healthcare professionals and substantial efforts are being encouraged to reduce the potential risks for future antipsychotics through more clinical trials and drug development.
In July 2013, the FDA issued a boxed warning for the antimalarial drug mefloquine, noting the drug's adverse neuropsychiatric side effects, and emphasizing neurological effects from the drug could "occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent". [23]
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