August 21, 2006
LONDON—Various European governmental authorities released warnings July 19 on the link between use of black cohosh (Cimicifugae racemosae rhizome) and numerous cases of hepatotoxicity. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (U.K.), as well as the European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC) reported case data involving their constituents and various degrees of adverse reaction to black cohosh supplementation.
MHRA (www.mhra.gov.uk) reported receiving 31 adverse reaction filings, 22 of which featured varying degrees of abnormal liver function, hepatitis or liver failure. It said warnings were being added to the labels of all black cohosh, and MHRA is working with the industry and marketers to ensure the public is fully aware of the potential risks associated with the use of these products.
This comes after HMPC (www.emea.eu.int) released results of its review of available data on the issue, which suggested a connection between herbal supplements containing black cohosh root and hepatotoxicity. In its review, HMPC evaluated 42 cases of hepatotoxicity collected from the European National Competent Authorities and from literature case reports. Of these cases, only 16 met review criteria; of these, 12 were discounted, and there was a temporal connection drawn in the remaining four cases—including autoimmune hepatitis, liver injury and liver failure. “After reviewing all available data, the Herbal Medicines Advisory Committee has come to the conclusion that black cohosh may be associated with liver disorders,” said Philip Routledge, chairman of the Herbal Medicines Advisory Committee. “This is rare, but can be serious.”
Also in response to these findings, EMEA advised Europeans to stop taking black cohosh root and consult their physicians immediately if they notice signs or symptoms of liver injury—tiredness, loss of appetite, jaundice of skin or eyes, severe upper stomach pain, nausea or vomiting. EMEA also advised health care professionals to ask patients about possible black cohosh use and report hepatic reactions to national adverse reaction reporting schemes.
This European reaction against black cohosh is the second such major governmental action, as Australia officials issued similar warnings and labeling regulations in early 2006. However, the American Herbal Products Association (AHPA) noted a National Institutes of Health (NIH) workshop held in November 2004 concluded the evidence for liver toxicity risks from black cohosh “remains equivocal but certainly warrants continued monitoring.” NIH (www.nccam.nih.gov) further noted, “At this time, there is no known mechanism with biological plausibility that explains any hepatotoxic activity of black cohosh.”
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