title: Selenium toxicity from a misformulated dietary supplement, adverse health effects, and the temporal response in the nail biologic monitor.
abstract: Use of dietary supplements in the U.S. has increased steadily over the last 25 years. While misformulation is uncommon, the consequences can be serious. A March 2008 voluntary market recall removed supplement products responsible for the most serious selenium toxicity outbreak that has occurred in the U.S. We quantified selenium concentrations in the misformulated supplement products, measured the temporal response in the nail biologic monitor, and associated exposure to self-reported selenosis symptoms. Subjects recruited through state health departments and referrals provided samples of the misformulated supplement products, exposure information, monthly toenail and or fingernail clippings or onycholysitic nail fragments, and listed their newly onset adverse health effects attributed to selenium toxicity. Ninety-seven subjects enrolled and submitted at least one test sample. Peak selenium concentrations (up to 18.3 and 44.1 μg/g for toenails and fingernails, respectively) were measured. Multiple samples (52 total) of all six recalled supplement lots were analyzed ranging from 22,300 to 32,200 μg selenium per daily dose. Average consumption was 30.9 ± 13.9 doses; 73 subjects provided follow-up data on selenosis symptoms at 2.50 ± 0.14 years. Nail samples accurately reflect exposure in this selenium toxicity outbreak, which resulted in long-term/permanent adverse health effects.
authors.affiliation: Research Reactor Center, University of Missouri, Columbia, MO 65211, USA. morrisj@missouri.edu
authors.forename: John Steven
authors.initials: JS
authors.lastname: Morris
authors.forename: Stacy B
authors.initials: SB
authors.lastname: Crane
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015415:Biomarkers / Q000378:metabolism; D002626:Chemistry, Pharmaceutical; D019587:Dietary Supplements / Q000009:adverse effects* / Q000032:analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009262:Nails / Q000378:metabolism*; D018673:Nutrition Policy; D011041:Poisoning / Q000175:diagnosis / Q000209:etiology / Q000378:metabolism; D056737:Safety-Based Drug Withdrawals; D012643:Selenium / Q000378:metabolism / Q000506:poisoning*; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States
chemical_list: D015415:Biomarkers; D012643:Selenium
references.citation: Epidemiology. 1996 Jul;7(4):384-90
references.pmid: 8793364
references.citation: Mutat Res. 2012 May 1;733(1-2):100-10
references.pmid: 22234051
references.citation: Ann Intern Med. 2008 Jun 17;148(12):970-1
references.pmid: 18559845
references.citation: Dose Response. 2009 Dec 21;8(3):285-300
references.pmid: 20877485
references.citation: J Am Diet Assoc. 2006 Dec;106(12):1966-74
references.pmid: 17126626
references.citation: Arch Intern Med. 2010 Feb 8;170(3):256-61
references.pmid: 20142570
references.citation: J Nutr. 1998 Feb;128(2 Suppl):375S-378S
references.pmid: 9478029
references.citation: J Trace Elem Med Biol. 2003;17 Suppl 1:31-6
references.pmid: 14650626
references.citation: Nutr Res Pract. 2011 Aug;5(4):357-64
references.pmid: 21994531
references.citation: Cancer Epidemiol Biomarkers Prev. 1993 Mar-Apr;2(2):107-12
references.pmid: 8467244
references.citation: J Natl Cancer Inst. 1998 Aug 19;90(16):1219-24
references.pmid: 9719083
references.citation: JAMA. 1996 Apr 10;275(14):1087-8
references.pmid: 8601925
references.citation: J Am Acad Dermatol. 2010 Jul;63(1):168-9
references.pmid: 20542184
references.citation: Rev Environ Health. 2001 Jul-Sep;16(4):233-51
references.pmid: 12041880
references.citation: Br J Nutr. 2001 May;85(5):517-47
references.pmid: 11348568
references.citation: J Biol Chem. 2004 Sep 3;279(36):37852-9
references.pmid: 15229221
references.citation: Am J Clin Nutr. 2007 Jan;85(1):318S-322S
references.pmid: 17209218
references.citation: Environ Res. 2011 May;111(4):514-9
references.pmid: 21316044
references.citation: Diabetes Care. 2012 Jul;35(7):1544-51
references.pmid: 22619078
references.citation: Pathology. 2007 Apr;39(2):289-90
references.pmid: 17454771
references.citation: Circ Cardiovasc Qual Outcomes. 2009 Jul;2(4):369-76
references.pmid: 20031863
references.citation: Am J Epidemiol. 2009 Apr 15;169(8):996-1003
references.pmid: 19221120
references.citation: Am J Physiol. 1989 Sep;257(3 Pt 2):R556-67
references.pmid: 2551194
references.citation: J Nutr. 2006 Feb;136(2):493S-501S
references.pmid: 16424134
references.citation: Am J Clin Nutr. 2012 Jul;96(1):111-22
references.pmid: 22648711
references.citation: Environ Health Perspect. 2009 Sep;117(9):1409-13
references.pmid: 19750106
references.citation: Annu Rev Nutr. 2005;25:215-35
references.pmid: 16011466
references.citation: Am J Epidemiol. 1990 Jul;132(1):114-22
references.pmid: 2356804
references.citation: Atherosclerosis. 2010 Jun;210(2):643-8
references.pmid: 20102763
references.citation: Am J Epidemiol. 2006 Apr 15;163(8):694-9
references.pmid: 16495471
references.citation: Am J Clin Nutr. 1991 May;53(5):1288-94
references.pmid: 2021136
references.citation: Am J Epidemiol. 2010 Apr 1;171(7):793-800
references.pmid: 20219762
references.citation: Annu Rev Nutr. 2012 Aug 21;32:369-90
references.pmid: 22524186
references.citation: Curr Opin Lipidol. 2008 Feb;19(1):43-9
references.pmid: 18196986
references.citation: Arch Intern Med. 2008 Feb 25;168(4):404-10
references.pmid: 18299496
references.citation: Cancer Epidemiol Biomarkers Prev. 1993 Sep-Oct;2(5):493-7
references.pmid: 8220096
references.citation: Science. 2003 May 30;300(5624):1439-43
references.pmid: 12775843
references.citation: Ann Intern Med. 2006 Sep 5;145(5):364-71
references.pmid: 16880454
references.citation: Mol Cell Biol. 2002 Jun;22(11):3565-76
references.pmid: 11997494
references.citation: Arch Toxicol. 1986 May;59(1):61-3
references.pmid: 3741146
references.citation: J Toxicol Clin Toxicol. 1986;24(1):21-35
references.pmid: 3701906
references.citation: Int J Vitam Nutr Res. 1996;66(4):350-62
references.pmid: 8979164
references.citation: J Am Diet Assoc. 1981 Sep;79(3):277-85
references.pmid: 7264113
references.citation: Ann Clin Lab Sci. 2006 Autumn;36(4):409-20
references.pmid: 17127727
references.citation: JAMA. 2012 Nov 14;308(18):1871-80
references.pmid: 23162860
references.citation: J Emerg Med. 2004 Feb;26(2):183-7
references.pmid: 14980341
references.citation: Ann Epidemiol. 2006 Jan;16(1):53-8
references.pmid: 15961316
references.citation: J Biol Inorg Chem. 2010 Jun;15(5):709-15
references.pmid: 20225071
references.citation: Am J Clin Nutr. 1993 Mar;57(3):408-13
references.pmid: 8438776
references.citation: Atherosclerosis. 2010 Jun;210(2):662-7
references.pmid: 20138620
references.citation: Nutr Metab Cardiovasc Dis. 2010 Dec;20(10):754-60
references.pmid: 21094028
references.citation: Am J Clin Nutr. 1983 May;37(5):872-81
references.pmid: 6846228
references.citation: Forensic Sci Int. 2007 Aug 24;171(1):67-72
references.pmid: 16891071
references.citation: Annu Rev Nutr. 2012 Aug 21;32:73-95
references.pmid: 22404120
references.citation: Clin Toxicol (Phila). 2012 Jan;50(1):57-64
references.pmid: 22165838
references.citation: J Natl Cancer Inst. 1995 Apr 5;87(7):497-505
references.pmid: 7707436
references.citation: Arch Intern Med. 2010 Feb 8;170(3):261-3
references.pmid: 20142571
references.citation: J Trace Elem Med Biol. 2004;18(1):69-74
references.pmid: 15487766
references.citation: Nutrition. 1999 Mar;15(3):255
references.pmid: 10408880
references.citation: Mol Nutr Food Res. 2012 Jul;56(7):1106-21
references.pmid: 22760983
references.citation: Am J Clin Nutr. 2011 Nov;94(5):1376-81
references.pmid: 21955646
references.citation: Biol Trace Elem Res. 1983 Dec;5(6):529-37
references.pmid: 24263672
references.citation: Am J Clin Nutr. 2008 Feb;87(2):379-84
references.pmid: 18258628
references.citation: Hum Exp Toxicol. 2010 May;29(5):431-4
references.pmid: 20106940
references.citation: Am J Clin Nutr. 1990 Nov;52(5):858-62
references.pmid: 2239761
references.citation: J Nutr. 2010 Feb;140(2):317-24
references.pmid: 20032488
references.citation: J Intern Med. 2011 Aug;270(2):175-86
references.pmid: 21205024
references.citation: Cancer Epidemiol Biomarkers Prev. 2006 Apr;15(4):804-10
references.pmid: 16614127
references.citation: Am J Clin Nutr. 2005 Apr;81(4):829-34
references.pmid: 15817859