Jeff Friedlin

A quantitative analysis of adverse events and "overwarning" in drug labeling.

Author Affiliations: Department of Orthopedics Hässleholm-Kristianstad, Hässleholm Hospital, Hässleholm, Sweden (Dr Atroshi); and Department of Orthopedics, Clinical Sciences Lund (Drs Atroshi and Tägil), and Musculoskeletal Sciences, Department of Orthopedics, Clinical Sciences Lund, and World Health Organization Collaborating Centre for Evidence-Based Healthcare in Musculoskeletal Disorders (Drs Englund and Petersson and Ms Turkiewicz), Lund University, Lund, Sweden. Correspondence: Dr Atroshi, Department of Orthopedics, Hässleholm Hospital, SE-28125 Hässleholm, Sweden (Isam.Atroshi@med.lu.se). Author Contributions: Dr Atroshi had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Atroshi, Englund, and Petersson. Acquisition of data: Atroshi, Englund, and Petersson. Analysis and interpretation of data: Atroshi, Englund, Turkiewicz, Tägil, and Petersson. Drafting of the manuscript: Atroshi and Petersson. Critical revision of the manuscript for important intellectual content: Atroshi, Englund, Turkiewicz, Tägil, and Petersson. Statistical analysis: Atroshi, Englund, and Turkiewicz. Obtained funding: Atroshi and Petersson. Administrative, technical, and material support: Petersson. Study supervision: Englund and Petersson. Financial Disclosure: None reported. Funding/Support: This project was funded by grants from Region Skåne, the Swedish National Insurance Agency, Hässleholm Hospital, the Swedish Research Council, and the Faculty of Medicine, Lund University. Dr Englund is supported by the Swedish Research Council and the Faculty of Medicine, Lund University. Role of the Sponsors: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Consistency in the safety labeling of bioequivalent medications.

Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real‐world consistency of electronic labeling for bioequivalent drugs from different manufacturers.