David Croteau1, Ellen Pinnow2, Eileen Wu2, Monica Muñoz2, Ilynn Bulatao2, Gerald Dal Pan2. 1. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA. david.croteau@fda.hhs.gov. 2. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
Abstract
INTRODUCTION: New safety issues concerning US FDA-approved drugs are commonly communicated through safety-related labeling changes. Therefore, to optimize and refine postmarket safety surveillance strategies, it is important to comprehensively characterize the sources of data giving rise to safety-related labeling changes. OBJECTIVES: Our objective was to characterize the sources of data triggering and supporting the identification of new safety risks of FDA-approved drugs communicated through safety-related labeling changes. METHODS: We conducted a retrospective study with a 10-year observation period using FDA's internal electronic data repositories for all prescription new molecular entities (NME) approved in 2008. We collected and analyzed information on new safety issues, the section of the full prescribing information updated, initiators (FDA, drug manufacturer), and triggering and supporting sources of evidence. RESULTS: Among 22 NMEs approved in 2008, 189 new safety issues for 18 NMEs were identified. Compared to drug manufacturer, FDA initiated safety-related labeling changes in nine of the ten changes to the Boxed Warnings, 28 of the 52 changes to the Warnings and Precautions, and 43 of the 134 changes to the Adverse Reactions sections of the full prescribing information. The most frequent triggering sources of evidence included the drug manufacturer safety database (32.3%) and FDA Adverse Event Reporting System (FAERS) safety reports (15.3%) for all relevant sections of the full prescribing information, and class-labeling changes (17.5%) for Boxed Warnings and the Warnings and Precautions sections. The most frequent triggering source of evidence was FAERS safety reports (69%) in the first year after drug approval and the drug manufacturer safety database in subsequent years. CONCLUSIONS: Our findings emphasize the continued importance of safety reports from FAERS and drug manufacturer safety databases and a comprehensive drug safety surveillance program throughout a drug's lifecycle.
INTRODUCTION: New safety issues concerning US FDA-approved drugs are commonly communicated through safety-related labeling changes. Therefore, to optimize and refine postmarket safety surveillance strategies, it is important to comprehensively characterize the sources of data giving rise to safety-related labeling changes. OBJECTIVES: Our objective was to characterize the sources of data triggering and supporting the identification of new safety risks of FDA-approved drugs communicated through safety-related labeling changes. METHODS: We conducted a retrospective study with a 10-year observation period using FDA's internal electronic data repositories for all prescription new molecular entities (NME) approved in 2008. We collected and analyzed information on new safety issues, the section of the full prescribing information updated, initiators (FDA, drug manufacturer), and triggering and supporting sources of evidence. RESULTS: Among 22 NMEs approved in 2008, 189 new safety issues for 18 NMEs were identified. Compared to drug manufacturer, FDA initiated safety-related labeling changes in nine of the ten changes to the Boxed Warnings, 28 of the 52 changes to the Warnings and Precautions, and 43 of the 134 changes to the Adverse Reactions sections of the full prescribing information. The most frequent triggering sources of evidence included the drug manufacturer safety database (32.3%) and FDA Adverse Event Reporting System (FAERS) safety reports (15.3%) for all relevant sections of the full prescribing information, and class-labeling changes (17.5%) for Boxed Warnings and the Warnings and Precautions sections. The most frequent triggering source of evidence was FAERS safety reports (69%) in the first year after drug approval and the drug manufacturer safety database in subsequent years. CONCLUSIONS: Our findings emphasize the continued importance of safety reports from FAERS and drug manufacturer safety databases and a comprehensive drug safety surveillance program throughout a drug's lifecycle.
Authors: Jean Lester; George A Neyarapally; Earlene Lipowski; Cheryl Fossum Graham; Marni Hall; Gerald Dal Pan Journal: Pharmacoepidemiol Drug Saf Date: 2013-01-02 Impact factor: 2.890
Authors: Ellen Pinnow; Sania Amr; Søren M Bentzen; Sonja Brajovic; Laura Hungerford; Diane Marie St George; Gerald Dal Pan Journal: Clin Pharmacol Ther Date: 2017-12-20 Impact factor: 6.875