UK's MHRA to Require Label Warning on Black Cohosh

(July 18, 2006, Silver Spring, MD) -- The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. issued a press release today in which it stated that it “is concerned about links between black cohosh (Actaea racemosa; syn: Cimicifuga racemosa) and the risk of liver disorders.” The Agency stated that the basis for its concern is that the Commission on Human Medicines and the Herbal Medicines Advisory Committee have both “reviewed all available data and concluded that the data underlines an association between black cohosh and risk of liver disorders.” MHRA has therefore determined that warnings will be required on labeling of black cohosh products and it “is working with the herbal sector to ensure the public is fully informed about this potential risk.”

The chairman of the Herbal Medicines Advisory Committee, Professor Philip Routledge, was quoted in the MHRA press release as saying, “After reviewing all available data, the Herbal Medicines Advisory Committee has come to the conclusion that black cohosh may be associated with liver disorders. This is rare, but can be serious.”

In an accompanying Q&A format document, MHRA stated that persons who are using black cohosh products and are “concerned or unwell” should consult their doctor, and listed liver problem symptoms. The Q&A document also noted, however, that persons who are taking black cohosh “who are feeling well need not take any action.”

A press release was also issued today by the European Medicines Agency (EMEA) to advise that persons “stop taking [black cohosh] and consult their doctor immediately if they develop signs and symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine).” EMEA stated that its advisory was based on a review by its Committee on Herbal Medicinal Products (HMPC), also dated today, of “a number of case reports of hepatotoxicity (liver injuries) in patients using [black cohosh].” Following this review, HMPC “considered that there is a potential connection between herbal medicinal products containing Cimicifugae racemosae rhizoma (Black Cohosh, root) and hepatotoxicity.” EMEA also advised practitioners to report any “suspected hepatic reactions” to their national adverse reaction reporting systems.

The U.K. is now the second country to state its intention to require liver-related label information on black cohosh products. The American Herbal Products Association (AHPA) reported on February 14, 2006, that the Australian Therapeutic Goods Administration has decided that medicines containing black cohosh should be labeled with the following statement: “Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional.” The Australian policy was effective immediately for new products, while existing products have until February 2007 to allow adequate time to comply with the new labeling requirements.

As was also noted in the February 14, 2006, press release, a workshop on black cohosh safety in clinical trials was held in November 2004 at the National Institutes of Health. This workshop concluded that the evidence for liver toxicity risks from black cohosh “remains equivocal but certainly warrants continued monitoring.” The NIH also noted, “At this time, there is no known mechanism with biological plausibility that explains any hepatotoxic activity of black cohosh.”

Today’s MHRA press release and Q&A are posted on AHPA’s website at http://www.ahpa.org/portals/0/pdfs/06_0718_PR_MHRA.pdf and http://www.ahpa.org/portals/0/pdfs/06_0718_Q&A_MHRA.pdf, respectively.

The EMEA press release is online at http://www.emea.eu.int/pdfs/human/hmpc/26925906en.pdf and the report of the HMPC is at http://www.emea.eu.int/pdfs/human/hmpc/26925806en.pdf.

A record of the 2004 NIH conference can be found at http://nccam.nih.gov/news/pastmeetings/blackcohosh_mtngsumm.htm.


###

The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish