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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.
REMS, write Singer and Bloom, "has been largely responsible for the underprescription and underuse of clozapine, the only FDA-approved drug for treatment-resistant schizophrenia, the most severe ...
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.
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.
Note: "Notable" is to mean side-effects that are particularly unique to the antipsychotic drug in question. For example, clozapine is notorious for its ability to cause agranulocytosis. If data on the propensity of a particular drug to cause a particular AE is unavailable an estimation is substituted based on the pharmacologic profile of the drug.
A study confirmed that side effects like pancreatitis and kidney damage are possible while taking GLP-1s like Ozempic. ... you should be aware of all potential risks before using a medication ...
This is a list of drugs and substances that are known or suspected to cause Stevens–Johnson syndrome This is a dynamic list and may never be able to satisfy particular standards for completeness. You can help by adding missing items with reliable sources .
It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3] Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns.