Post-Marketing Drug Safety Sources: An Evaluation of the FDA’s Drug Safety Communications in the Past 10 Years

Abstract Background: The United States Food and Drug Administration (FDA) regularly disseminates Drug Safety Communications (DSCs) to inform healthcare professionals and consumers about important safety concerns related to marketed medicinal products. These communications usually contain evidence used to support regulatory decision-making. Objectives: This study reviews and assesses the association between the types of data sources utilized in DSCs and subsequent regulatory actions from January 2015 to January 2024. Materials and Methods: A cross-sectional analysis was conducted on all DSCs published on the FDA’s website from 2015 to 2024. Descriptive statistics were used to summarize the characteristics of the DSCs, including the year of publication, medication therapeutic group, adverse events (AEs) categorized by system organ class, data sources, and regulatory actions. A univariate logistic regression was performed to assess the association between the evidence source type and the FDA’s regulatory actions. Results: A total of 87 DSCs met the inclusion criteria for the final analysis, with the highest number issued in 2015 (25.3%). The most frequently reported therapeutic classes included antidiabetic drugs (13.8%), analgesics/opioids (11.5%), and antipsychotics (6.9%). The top AEs by system organ class reported were cardiac disorders (14.9%). Label updates were the predominant regulatory action, accounting for 70.1% of cases. Univariate logistic regression analyses found no statistically significant association between spontaneous case reports as sources of the evidence and drug labeling updates (OR = 1.80; 95% CI [0.71, 4.54]; P = 0.21). However, DSCs that referenced two or more evidence sources were significantly more likely to result in a label update compared to those citing a single evidence source (OR = 2.91; 95% CI [1.12, 7.59]). Conclusion: Spontaneous reports and the number of cited observational studies were the most frequently utilized evidence sources in the FDA’s DSCs that led to drug labeling updates. These findings demonstrate the necessity for rigorous evidence integration in guiding regulatory decisions and enhancing drug safety monitoring.