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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

TABLE D Chaparral: Summary of Adverse Event Reports from the Special Nutritionals Adverse Event Monitoring System (SN/AEMS)a

Category

Number of Subjects

Supplement

Adverse Events

Hepatic

1

Chaparral

Hepatitis (nonviral), nausea, fever

 

1

Chaparral

Severe liver problems, kidney failure

 

1

Chaparral

Severe hepatic injury with bile duct narrowing and cholestasis

 

1

Chaparral

Acute toxic hepatitis, jaundice, abdominal pain, pruritus, dark urine

 

1

Chaparral

Hepatitis

 

1

Chaparral

Hepatitis

 

1

Chaparral

Hepatitis, jaundice

 

1

Chaparral

Jaundice, cholangitis, colitis, nausea, vomiting

 

1

Chaparral

Jaundice, nausea

 

1

Chaparral

Jaundice

 

1

Chaparral (or chaparral-containing product, unspecified)

Jaundice

 

1

Chaparral

Chaparral toxicity (likely hepatic involvement)

 

1

Chaparral

Coma, liver damage

NOTE: There were reports in this monitoring system of five additional subjects who took chaparral along with other dietary supplements. These subjects were not considered in this analysis due to the unclear association between the adverse events and the use of chaparral as a result of the concomitant use of multiple dietary supplements. However, it should be noted that these five additional adverse events involved two deaths, two cases of hepatitis, and tachycardia with loss of vision in one eye.

a The Food and Drug Administration’s SN/AMES is currently in the process of being updated to track and analyze adverse event reports related to dietary supplements. The information contained in this monograph was obtained from the system prior to August 29, 2002, when the database was withdrawn from the Internet.

Page
436
Front Matter (R1-R20)
Executive Summary (1-18)
1 Introduction and Background (19-42)
2 Approaches Used by Others and Existing Safety Frameworks (43-84)
3 The Framework (85-125)
4 Categories of Scientific Evidence--Human Information and Data (126-155)
5 Categories of Scientific Evidence--Animal Data (156-174)
6 Categories of Scientific Evidence--Information About Related Substances (175-216)
7 Categories of Scientific Evidence--In Vitro Data (217-234)
8 Interactions (235-246)
9 Vulnerable Groups and Prevalance of Use (247-252)
10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)
11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)
12 Factors Influencing Use of the Safety Framework (292-296)
13 Findings and Recommendations (297-306)
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)
Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)
Appendix C: Plant Family Information (322-355)
Appendix D: Chaparral: Prototype Monograph Summary (356-362)
Appendix E: Glucosamine: Prototype Monograph Summary (363-366)
Appendix F: Melatonin: Prototype Monograph Summary (367-371)
Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)
Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)
Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)
Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)
Appendix L: Acknowledgements (478-480)
Appendix M: Biographical Sketches of Commitee Members (481-488)
Index (489-506)