Author Contributions: Dr Budnitz 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: Budnitz, Pollock, Schroeder.
Acquisition of data: Budnitz, Weidenbach, Schroeder, Annest.
Analysis and interpretation of data: Budnitz, Pollock, Weidenbach, Mendelsohn, Schroeder.
Drafting of the manuscript: Budnitz, Pollock, Weidenbach.
Critical revision of the manuscript for important intellectual content: Budnitz, Mendelsohn, Schroeder, Annest.
Statistical analysis: Budnitz, Weidenbach, Mendelsohn, Schroeder, Annest.
Obtained funding: Budnitz.
Administrative, technical, or material support: Budnitz, Weidenbach, Schroeder.
Study supervision: Budnitz, Pollock.
Financial Disclosures: Dr Mendelsohn contributed to this research while he was a CDC Epidemic Intelligence service officer assigned to the Office of Drug Safety, FDA. Financial support was solely through his US government salary. Dr Mendelsohn is now director of epidemiology at MedImmune Inc. None of the products marketed by MedImmune, nor competitors' products, are specifically addressed in this article. None of the other authors reported financial disclosures.
Funding/Support: This work was implemented by CDC, FDA, and US Consumer Product Safety Commission (CPSC) scientists. CDC provided funding for the study and FDA provided funding for medical coding of the data using MedDRA terms and analyses.
Role of the Sponsors: The CDC provided funding for the design and conduct of the investigation; data collection, management, analysis, and interpretation; and preparation and review of the manuscript.
Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the views of CDC, FDA, or the CPSC.
Acknowledgment: We thank Steve Brown, MD, of the US Department of Veterans Affairs for providing the National Drug File Reference Terminology; Terri Nelson, BA, of the US CPSC and Shelley Elbert, MA, formerly of CPSC for their assistance with data collection; Cathy Irish, BS, of CPSC and Jacqui Butler, MPA, of the CDC for technical support; Benjamin Kupronis, MPH, and Tadesse Haileyesus, MS, of CDC for programming assistance; and Art McDonald, MPhil, formerly of CPSC and Anne Trontell, MD, from the FDA for assistance in study design and conceptualization. No individuals named herein received compensation for their contributions.