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Summaries of safety labeling changes approved by FDA—Boxed warnings highlights, April–June 2022, American Journal of Health-System Pharmacy, Volume 79, Issue 17, 1 September 2022, Page 1404, https://doi.org/10.1093/ajhp/zxac197
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Extract
As part of FDA’s MedWatch program, important changes to the safety labeling of drugs and therapeutic biologicals, including boxed warnings, are posted on the agency’s website. Boxed warnings are ordinarily used to highlight (1) an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that the reaction be considered in assessing the risks and benefits of using the drug, (2) serious adverse reactions that can be prevented or reduced in frequency or severity by appropriate use of the drug, and (3) situations in which FDA approved a drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.1 The following revisions to warnings were implemented in the 3 months ending June 2022.
Lincocin (lincomycin hydrochloride)
In keeping with currently accepted nomenclature, “Clostridioides difficile” replaces “Clostridium difficile” in the boxed warning and throughout the product labeling.
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