+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014



Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014



Pharmacoepidemiology and Drug Safety 25(6): 713-718



Label="PURPOSE">Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014.Label="METHODS">Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings.Label="RESULTS">In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories.Label="CONCLUSIONS">By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 057478125

Download citation: RISBibTeXText

PMID: 26861066

DOI: 10.1002/pds.3979


Related references

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Pharmacoepidemiology and Drug Safety 21(6): 565-70; Discussion 571-2, 2012

Adverse drug event reports at the United States Food And Drug Administration Center for Veterinary Medicine. Journal of the American Veterinary Medical Association 225(4): 533-536, 2004

Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. Pharmacoepidemiology and Drug Safety 18(1): 24-27, 2008

Completeness of adverse drug reactions reports of the Saudi adverse event reporting system. Saudi Medical Journal 36(7): 821-828, 2015

Medical device adverse event reports and the Food and Drug Administration. Journal of Vascular Surgery 40(2): 395-396, 2004

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability. Federal Register 81(121): 40890-1, 2016

Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases. Yakugaku Zasshi 136(3): 507-515, 2016

Adverse Event Reports Submitted to U.S. Food & Drug Administration Associated with Dietary Supplements. Planta Medica 75(4): s-2009-1216430, 2009

10-Year Analysis of Adverse Event Reports to the Food and Drug Administration for Phosphodiesterase Type-5 Inhibitors. Yearbook of Urology 2012: 135-136, 2012

Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995. Public Health Reports 113(6): 535-543, 1998

10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. Journal of Sexual Medicine 9(1): 265-270, 2012

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Epilepsy Research 135: 71-78, 2017

Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration's adverse event reporting system. Expert Opinion on Drug Safety 14(11): 1653-1660, 2015

Food and Drug Administration Adverse Event Reports of Retinal Vascular Occlusions Associated With Phosphodiesterase Type 5 Inhibitor Use. Journal of Neuro-Ophthalmology 36(4): 480-481, 2016

Nonsteroidal anti-inflammatory drug-associated pulmonary infiltrates with eosinophilia. Review of the literature and Food and Drug Administration Adverse Drug Reaction reports. Archives of Internal Medicine 152(7): 1521-1524, 1992