NDLI: Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Garg, Vishvas Raisch, Dennis W. McKoy, June M. Trifilio, Steven M. Holbrook, Jamiee Edwards, Beatrice J. Belknap, Steven M. Samaras, Athena T. Nardone, Beatrice West, Dennis P.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Garg V ( University of New Mexico, College of Pharmacy, Albuquerque, NM 87131, USA. vgarg@salud.unm.edu)
Abstract	PURPOSE: To determine the relationship between boxed warnings issuance by the US Food and Drug Administration (FDA) and the proportional reporting rates of the associated adverse drug reactions (ADRs) to the FDA's Adverse Event Reporting System (FAERS) for multiple myeloma (MM) drugs. METHODS: We compiled a list of all FDA approved MM drugs and identified their associated ADR boxed warnings, through FDA's website and physician desk reference. Drugs that were issued boxed warnings after their market launch were included in the analysis, i.e., melphalan, thalidomide, vincristine, carmustine and doxorubicin. For each drug/ADR boxed warning combination, we retrieved all reported cases from the FAERS and calculated their Empiric Bayes Geometric Means (EBGMs), in pre- and post-boxed warning periods. Chi-square tests were performed to compare serious adverse drug events before and after boxed warnings for all drug/ADR combinations. RESULTS: A total of 10 drug/ADR boxed warning combinations were identified, of which EBGM signals increased for six combinations after a boxed warning was issued. Reports of serious adverse drug events also increased significantly (p < 0.05). CONCLUSION: Boxed warnings were associated with increased FAERS reporting, indicating increased awareness of ADRs for MM drugs. Proactive pharmacovigilance programs, such as the FDA's Mini-Sentinel Project, may improve timeliness of detection of rare ADRs.
File Format	HTM / HTML
ISSN	14740338
Issue Number	3
Volume Number	12
e-ISSN	1744764X
Journal	Expert Opinion on Drug Safety
Language	English
Publisher	Taylor & Francis
Publisher Date	2013-05-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Antineoplastic Agents Adverse Effects Drug Information Services Drug Labeling Drug-related Side Effects And Adverse Reactions Epidemiology Multiple Myeloma Drug Therapy Administration & Dosage Prevention & Control Humans Product Surveillance, Postmarketing Retrospective Studies United States United States Food And Drug Administration Journal Article Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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