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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information contained in this monograph was obtained from the system prior to August 29, 2002, when the database was withdrawn from the Internet.



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