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OA12.01. Analysis of FDA mandated dietary supplement adverse event reports (AER) 2008-2009

Authors
Journal
BMC Complementary and Alternative Medicine
1472-6882
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Volume
12
Identifiers
DOI: 10.1186/1472-6882-12-s1-o45
Keywords
  • Oral Presentation

Abstract

OA12.01. Analysis of FDA mandated dietary supplement adverse event reports (AER) 2008-2009 ORAL PRESENTATION Open Access OA12.01. Analysis of FDA mandated dietary supplement adverse event reports (AER) 2008-2009 M Hardy1*, S Stumpf1, M Zimmerman2, C Carr1 From International Research Congress on Integrative Medicine and Health 2012 Portland, Oregon, USA. 15-18 May 2012 Purpose Safety of dietary supplements has been an area of con- cern for regulators, the health care community and con- sumers. The ability of the FDA to assess validity of these concerns has been hampered by small numbers of voluntary AE reports. In 2006 Congress mandated all serious adverse events be reported by dietary supple- ment manufacturers. We present the first systematic analysis of the initial two years of reports. Methods We obtained AER’s for 2008 and 2009 from the FDA (n=2,288). Data were abstracted by a single reviewer, confirmed by at least one other, entered into a standard excel sheet, and analyzed using SPSS. Non-parametric tests of significance were also applied. Results In preliminary results, manufacturers accounted for 57.8% of all reports, consumers 29.6% and health care professionals 9.7%. 61.8% of subjects were female. The most commonly reported dietary ingredients were com- bination products (33.5%), vitamin/mineral (19%), and plant or isolated plant constituent (15.8%). 297 reports included multiple products. Fifty-five percent of reports included the label or label information. The most com- mon adverse outcome was hospitalization (750, 32.8%). Thirty-one deaths were reported (1.4% total reports), 56 episodes of disability (2.4%), 233 life-threatening compli- cations (10.2%), and 943 other serious adverse events (41.2%). A detailed assessment of deaths, hospitalizations and life threatening complications will be presented. No single product type or ingredient was significantly asso- ciated with death. Attempts to apply the WHO-UMC causality assessment system yielded limited results an

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