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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

of a physician or health practitioner experienced in the use of botanical medicines. At least three informational websites that did not sell products cautioned against the use of chaparral capsules since several adverse event reports were associated with this form.

Cautions issued by manufacturing associations: In 1994 the American Herbal Products Association (AHPA) commissioned a review. Four case studies were examined and it was concluded that:

… since the patients were ingesting chaparral during the time each developed acute hepatitis, most likely of a hepatocellular nature, it is reasonable to conclude a relationship exists between the ingestion and the disease. However, no clinical data were found in the medical records to indicate that chaparral is inherently a hepatic toxin. Moreover, each patient had a medical history not incompatible with prior liver disease. A fair conclusion is [that] the disease in each patient was the result of an individual idiosyncratic reaction to the drug [botanical product], possibly the result of an autoimmunologic reaction, which given the quantity of chaparral ingested in this country, must be exceedingly rare (AHPA, 2002).

Following the Food and Drug Administration (FDA) warning issued in 1992 (see Section IIIE, below), many manufacturers voluntarily removed most products containing this botanical (FDA, 1993). In 1995 AHPA recommended that if member companies chose to sell chaparral, all consumer labeling contain the following informational language:

Seek advice from a health care practitioner before use if you have had, or may have had, liver disease. Discontinue use if nausea, fever, fatigue or jaundice (e.g., dark urine, yellow discoloration of the eyes) should occur (APHA, 2002).

D. Usage Patterns

Prevalence of use in the general population: According to a survey conducted by the Herb Research Foundation from 1973 to 1993, at least 200 tons of chaparral was sold in the U.S. market (Blumenthal, 1993). This would be equivalent to 500 million doses at 500 mg/dose. No current data are available; there has been no recent tracking of sales data.

Knowledge of use by particular groups: There are no published surveys in the literature that provide knowledge about the use of chaparral by specific groups. However, anecdotal reports suggest that indigenous American Indian groups in the southwestern United States and Hispanics may use chaparral, primarily as an aqueous extract (tea).

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395
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)