Boxed Warnings Perceptions by Consumers

As we know, the benefit/risk ratio of any drug can be defined only when it is on the market, and after several thousand patients have taken it: and therefore, it often happens that the information about its safety must be updated regularly. The Center for Drug Evaluation and Research (CDER) plays a key role in providing safety information about medicines, particularly through boxed warnings (BWs) on prescription drug labels. These warnings highlight serious risks to help healthcare providers (HCPs) and patients make informed decisions. A qualitative study was conducted by CDER and researchers to examine how HCPs interpret and communicate BW information when making treatment decisions. The study focused on two medicines with BWs: an oral antiviral for hepatitis C (HCV) and an estrogen vaginal insert for vulvovaginal atrophy (VVA). Interviews with 52 HCPs revealed how BWs influence their risk-benefit assessments and patient discussions.¹

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References

1. Research, C. F. D. E. A. (2024, September 3). Prescriber Perceptions of Boxed Warnings: A Qualitative study. U.S. Food And Drug Administration. https://www.fda.gov/drugs/spotlight-cder-science/prescriber-perceptions-boxed-warnings-qualitative-study

Disclaimers

• The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
• Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
• No official support by any organization(s) has been provided or should be inferred

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