Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: A cohort study focused on first-in-class drugs.

ABSTRACT

PURPOSE: First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focus on FIC drugs. METHODS: New molecular entities and new therapeutic biologics approved in the United States between 1 January 2003 and 31 December 2013 were included in the analysis. Important drug-specific PSRAs were defined as market withdrawal or the addition of new black box warnings or warnings due to adverse drug reactions. The relationship between baseline characteristics and the occurrence of important drug-specific PSRAs was investigated using a multivariate logistic regression model. We also defined the event as the first important PSRA and estimated the time-to-event for each factor. RESULTS: ATC category L (antineoplastic and immunomodulating agents) and FIC drug classification were shown to be statistically significant factors, with odds ratios of 2.15 (95% CI 1.12-4.11; P = 0.0203) and 1.87 (95% CI 1.06-3.31; P = 0.0309), respectively. ATC category L and FIC drugs were also significant factors for time to occurrence of the first event. CONCLUSION: FIC designation and ATC category L were identified as factors related to important drug-specific PSRAs. These factors were also associated with the time to occurrence of the first important drug-specific PSRAs.