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Article History

Accepted: 28 April 2024

First Online: 16 May 2024

Change Date: 29 May 2024

Change Type: Update

Change Details: The original article has been corrected. Co-author's family name has been corrected as ‘Dal Pan’

Declarations

:

: This work was funded by the Center for Drug Evaluation and Research at the US FDA (Contract number 75F40120C0044). Ameet Sarpatwari and Aaron S. Kesselheim’s work was also supported by grant funding from Arnold Ventures. Katsiaryna Bykov’s effort was also supported by the National Institutes of Health (K01AG068365).

: Ameet Sarpatwari reports having served as an expert witness on REMS-related litigation concerning mifepristone. Katsiaryna Bykov reports consulting fees from Alosa Health for unrelated work. Mufaddal Mahesri, Krista F. Huybrechts, Joyce Lii, Su Been Lee, Gita A. Toyserkani, Cynthia LaCivita, Esther H. Zhou, Gerald J. Dal Pan, and Aaron S. Kesselheim have no conflicts of interest to report.

: The study was conducted using de-identified data and approved by the Mass General Brigham Institutional Review Board (IRB # 2020P002183).

: Data supporting the findings of the study are available from the Centers of Medicare & Medicaid Services (CMS), Optum’s de-identified Clinformatics® Data Mart Database, and Merative Marketscan. Restrictions apply to the availability of these data, which were used under license for this study.

: Programming codes are available from the corresponding author upon request.

: Not applicable.

: Not applicable.

: MM, AS, KFH, GAT, CL, EHZ, GJDP, ASK, and KB contributed to the conception and design of the study. All authors analyzed the data. MM, AS, and KB wrote the first draft of the manuscript. All authors critically revised the manuscript and approved the final manuscript.