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Drug safety communications DSCs are the primary tool for the US Food and Drug Administration FDA to communicate important new postmarketing safety information to patients and health care professionals. Our objective was to describe the sources of the initial safety signals that lead to DSCs and examine their associations with drug characteristics and subsequent label changes. We used the Fisher exact test for categorical variables and the Wilcoxon rank sum test for continuous variables to examine associations between information source and initial regulatory approval pathways, time in years between initial approval and DSC posting, characteristics of clinical studies included in the most recent drug label prior to DSC publication, and subsequent safety-related changes to the drug label. We used Spearman rank correlation testing to examine for changes in the number of DSCs issued annually. Analyses were performed using SAS, version 9. Despite known underreporting of safety information to voluntary passively collected pharmacovigilance programs, the large proportion of DSCs initiated by FAERS suggests that the FDA relies on the program for postmarket drug safety monitoring. Similarly, the continued utility of RCTs for identifying new safety issues is at odds with recent legislation promoting the replacement of traditional RCTs with real-world data analyses to help support the approval of supplemental indications or the fulfillment of postapproval study requirements. This study has limitations. First, the source of the initial safety signal triggering DSCs might not have been clearly stated or represent all safety data reviewed by the FDA. Second, the present study was limited to initial safety signals. Inclusion of secondary or confirmatory safety signals may have represented different information sources. These data might inform clinicians and regulators of the current state of postmarketing monitoring of toxic effects and assist in guiding future improvement efforts. Published Online: September 3, Author Contributions : Drs Tau and Shepshelovich had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Critical revision of the manuscript for important intellectual content: All authors. No other disclosures were reported. Download PDF Comment. Table 1. Characteristics of DSCs. View Large Download. Table 2. Food and Drug Administration. Guidance: Drug Safety Information. FDA's communication to the public. Accessed May 31, Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between and PubMed Google Scholar. Drug safety communications. Kesselheim AS, Avorn J. This cohort study assesses the association between initiation of sodium-glucose cotransporter 2 SGLT-2 inhibitor treatment and the risk of hospitalization for Fournier gangrene among men. Chintan V. Save Preferences. Privacy Policy Terms of Use. This Issue. Views 2, Citations View Metrics. X Facebook More LinkedIn. Research Letter. Editor's Note. Back to top Article Information. Access your subscriptions. Access through your institution. Add or change institution. Free access to newly published articles. Purchase access. Rent article Rent this article from DeepDyve. Sign in to access free PDF. Save your search. Customize your interests. Create a personal account or sign in to:. Privacy Policy. Make a comment.

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