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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.
Pharmacoepidemiol Drug Saf. 2018 12; 27(12):1393-1401.PD

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.

Authors+Show Affiliations

Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan. Department of Clinical Development, Department of Biometrics, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30094880

Citation

Ikeda, Junji, et al. "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." Pharmacoepidemiology and Drug Safety, vol. 27, no. 12, 2018, pp. 1393-1401.
Ikeda J, Kaneko M, Narukawa M. 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. Pharmacoepidemiol Drug Saf. 2018;27(12):1393-1401.
Ikeda, J., Kaneko, M., & Narukawa, M. (2018). 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. Pharmacoepidemiology and Drug Safety, 27(12), 1393-1401. https://doi.org/10.1002/pds.4634
Ikeda J, Kaneko M, Narukawa M. 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. Pharmacoepidemiol Drug Saf. 2018;27(12):1393-1401. PubMed PMID: 30094880.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ikeda,Junji, AU - Kaneko,Masayuki, AU - Narukawa,Mamoru, Y1 - 2018/08/10/ PY - 2018/02/18/received PY - 2018/07/09/revised PY - 2018/07/10/accepted PY - 2018/8/11/pubmed PY - 2019/9/24/medline PY - 2018/8/11/entrez KW - US Food and Drug Administration KW - adverse drug reaction KW - first-in-class KW - pharmacoepidemiology KW - safety-related regulatory action SP - 1393 EP - 1401 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 27 IS - 12 N2 - 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. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/30094880/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_ L2 - https://doi.org/10.1002/pds.4634 DB - PRIME DP - Unbound Medicine ER -