The state of dietary supplement adverse event reporting in the United States
Article first published online: 9 JUL 2008
Copyright © 2008 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 17, Issue 10, pages 962–970, October 2008
How to Cite
Gardiner, P., Sarma, D. N., Dog, T. L., Barrett, M. L., Chavez, M. L., Ko, R., Mahady, G. B., Marles, R. J., Pellicore, L. S. and Giancaspro, G. I. (2008), The state of dietary supplement adverse event reporting in the United States. Pharmacoepidem. Drug Safe., 17: 962–970. doi: 10.1002/pds.1627
- Issue published online: 24 SEP 2008
- Article first published online: 9 JUL 2008
- Manuscript Accepted: 8 MAY 2008
- Manuscript Revised: 21 APR 2008
- Manuscript Received: 4 JAN 2008
- dietary supplements;
- adverse event reporting
The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP–National Formulary (USP–NF) quality monographs. Because the veracity of dietary supplement adverse event reports (DS AERs) directly affects DSI-EC safety reviews, the Committee reviewed the current status of DS AER reporting in the US.
DSI-EC reviewed PubMed searches, information from the US Food and Drug Administration's (FDA) MedWatch program, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC), and reports from US and other agencies. DSI-EC analyzed this information to identify key factors that affect the quality of DS AERs.
The overall incidence of DS AERs appears generally to be low. However, the primary reporting portal (FDA MedWatch) receives fewer AERs than do poison control centers (PCCs), and limited coordination exists among national and international surveillance programs for evaluating signals that may indicate potential public health risks. Both inadequate and poor-quality reporting of DS AERs are major limitations of DS safety monitoring in the US.
Based on its assessments, the Committee advances recommendations to improve the quality of reporting, monitoring, and assessing DS AERs. These include (1) enhanced data collection approaches, (2) improved coordination of AER surveillance programs, (3) strengthening of educational programs for public and health care sectors, and (4) conduct of research concerning the safety of DS. If taken, these approaches are expected to improve the health and well-being of DS users. Copyright © 2008 John Wiley & Sons, Ltd.