-
Views
-
Cite
Cite
Summaries of safety labeling changes approved by FDA—Boxed warnings highlights, April–June 2021, American Journal of Health-System Pharmacy, Volume 78, Issue 19, 1 October 2021, Pages 1763–1764, https://doi.org/10.1093/ajhp/zxab315
- Share Icon Share
Extract
The full summaries appear in the online version of this issue (academic.oup.com/ajhp).
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 2021.
Bijuva (estradiol and progesterone)
The revised box warning emphasizes that, because of limitations in data from the Women’s Health Initiative (WHI) study, no conclusions can be drawn about the risk of adverse cardiovascular events, dementia, or breast cancer from hormonal regimens at any dosage, dosage form, or route of administration other than those used in the WHI study. The warning also emphasizes that estrogen monotherapy and estrogen–progestogen combination therapy must not be used for the prevention of cardiovascular disease or dementia.
Comments