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Black cohosh safety/efficacy review

This article was originally published in The Tan Sheet

Executive Summary

Health Canada is taking a "precautionary approach" and reviewing black cohosh safety and efficacy, even though "case reports of liver damage are rare, and the link between black cohosh and liver toxicity is unclear," the regulator states in an Aug. 18 release, which additionally notes that "the quality of the black cohosh products involved in these cases is not known." The review follows on the heels of the UK's Medicines and Healthcare products Regulatory Agency's recent decision to add warnings to black cohosh products about the risk of liver disorders (1"The Tan Sheet," July 24, 2006, p. 14). Australia's Therapeutics Goods Association mandated a warning label on products containing the herb in February. Health Canada advises consumers to exercise caution in the use of black cohosh until the review is completed. Additionally, consumers should discontinue use if they have unusual fatigue, weakness, loss of appetite, or if they develop symptoms suggestive of liver injury such as yellowing of the skin, Health Canada states...

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Black cohosh alternative

Acatris is positioning its flax lignans ingredient, LinumLife EXTRA, as an alternative to black cohosh for women looking to relieve menopausal symptoms, the firm announces Aug. 24. "Lignans have a balancing effect on hormones because they are phytoestrogens, a plant compound similar to estrogen," a release states. LinumLife EXTRA, which launched earlier this year, can be formulated into one-per-day capsules or tablets; a 250 mg dose of the ingredient provides 50 mg of lignans, Acatris states. Black cohosh has come under review recently from Health Canada and the UK's Medicines & Healthcare products Regulatory Agency regarding safety concerns about the herb's potentially damaging effect on liver function (1"The Tan Sheet," Aug. 28, 2006, In Brief and 2"The Tan Sheet," July 24, 2006, p. 14)...

EU Agencies Call Attention To Link Between Black Cohosh, Liver Risks

The UK's Medicines & Healthcare products Regulatory Agency (MHRA) will add warnings to black cohosh products about the risk of liver disorders associated with use of the herbal, the agency states in a release July 18

EU ‘Structured Dialog’ Offers Opportunity To Secure Supply

A “structured dialog” led by the European Commission with pharmaceutical industry stakeholders provides a critical opportunity to address weaknesses in the stability and security of the supply chain by improving the environment for local manufacturing, Medicines for Europe believes.





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