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Research Article| Volume 26, ISSUE 1, P227-241, March 2006

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Hepatotoxicity Associated with Herbal Products

      A significant number of herbal products have been associated with hepatotoxicity. Unlike pharmaceutic products that undergo clinical trials before release to the public, herbal products have no preapproval evaluation time period in which liver injury may be identified. The association of hepatic injury with an herbal product is recognized only after numerous patients have contracted disease. This problem is confounded by the fact that less than 1% of the adverse events associated with dietary supplements are reported to the US Food and Drug Administration (FDA) [

      Walker A. The relationship between voluntary notification and material risk in dietary supplement safety. In: Administration UFaD, editor. FDA docket 00N–1200; 2000.

      ]. Attribution of liver injury to a specific herbal product may be difficult. There are few clinical or laboratory manifestations that specifically suggest that liver injury is the result of a specific herbal. The most important clue often is the temporal relationship between initiation of the herbal product and the appearance of liver injury, and of equal importance is the resolution of the injury following withdrawal of the herbal product [
      • Maddrey W.C.
      Drug-induced hepatotoxicity: 2005.
      ].
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