PMID- 30513022
OWN - NLM
STAT- MEDLINE
DCOM- 20200930
LR  - 20200930
IS  - 1939-022X (Electronic)
IS  - 1939-0211 (Linking)
VI  - 17
IP  - 2
DP  - 2020
TI  - Serious Adverse Events Reported with Dietary Supplement Use in the United States: 
      A 2.5 Year Experience.
PG  - 227-248
LID - 10.1080/19390211.2018.1513109 [doi]
AB  - Dietary supplement marketers assure the safety of their products by complying 
      with current good manufacturing practices and a host of federal regulations, 
      including those enforced by the Food and Drug Administration (FDA). Post-market 
      surveillance is a key part of identifying safety problems associated with dietary 
      supplement products. FDA requires dietary supplement marketers to provide a 
      domestic address or phone number on product labels for consumers, family members, 
      or health care professionals to report adverse events (AEs) associated with 
      product use and to report all serious adverse events (SAEs) to the agency within 
      15 business days of receipt. We aimed to evaluate the characteristics of AEs 
      reported with dietary supplement use, including dietary supplement type and 
      Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) 
      that occur with reported SAEs. A total of 41,121 unique adverse event cases 
      reported to two large, U.S.-based dietary supplement marketers in a 2.5-year 
      period (March 1, 2014-August 31, 2016) were assessed for seriousness using 
      established criteria. Each SAE was assigned one or more MedDRA preferred terms 
      and system organ classes (SOC). The types of supplements most responsible for 
      SAEs were assessed. Of the 41,121 AE cases reported, 203 (0.48%) were SAEs. SAEs 
      tended to occur with products marketed for weight loss (69.0%) and glycemic 
      control (19.2%). SAEs occurred most commonly in the cardiovascular, 
      gastrointestinal, and nervous system disorder SOCs. The percentage of SAEs 
      reported to dietary supplement marketers is low, predominantly among consumers of 
      two types of supplements. Further study is needed among a larger cohort of 
      supplement users to determine causal associations between types of supplement 
      products and serious adverse events.
FAU - Schmitz, Stephen M MD, MPH
AU  - Schmitz SM MD, MPH
AD  - Supplement Safety Solutions, Bedford, MA, USA.
FAU - Lopez, Hector L MD, MS
AU  - Lopez HL MD, MS
AD  - Supplement Safety Solutions, Bedford, MA, USA.
AD  - The Center for Applied Health Sciences, Stow, OH, USA.
FAU - Mackay, Douglas ND
AU  - Mackay D ND
AD  - Council for Responsible Nutrition, Washington, DC, USA.
FAU - Nguyen, Haiuyen BS
AU  - Nguyen H BS
AD  - Council for Responsible Nutrition, Washington, DC, USA.
FAU - Miller, Paula E BS
AU  - Miller PE BS
AD  - Supplement Safety Solutions, Bedford, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20181204
PL  - England
TA  - J Diet Suppl
JT  - Journal of dietary supplements
JID - 101249830
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Dietary Supplements/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*classification
MH  - Female
MH  - Guidelines as Topic
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - Terminology as Topic
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - CFSAN
OT  - DSHEA
OT  - FDA regulation of dietary supplements
OT  - adverse event
OT  - dietary supplement
OT  - nutravigilance
OT  - serious adverse event
OT  - supplement safety
EDAT- 2018/12/05 06:00
MHDA- 2020/10/02 06:00
CRDT- 2018/12/05 06:00
PHST- 2018/12/05 06:00 [pubmed]
PHST- 2020/10/02 06:00 [medline]
PHST- 2018/12/05 06:00 [entrez]
AID - 10.1080/19390211.2018.1513109 [doi]
PST - ppublish
SO  - J Diet Suppl. 2020;17(2):227-248. doi: 10.1080/19390211.2018.1513109. Epub 2018 
      Dec 4.