The MHRA said it wants warning labels to appear on black cohosh containing products. Its opinion was informed by the Commission on Human Medicines and the Herbal Medicines Advisory Committee, both of which have concluded that “the data underlines an association between black cohosh and risk of liver disease”.
Details of the data reviewed by the two committees was not available. But the EMEA’s advice to doctors and patients, also published yesterday, was informed by a third evaluation, by the Committee on Herbal Medicinal Products (HMPC), which looked at 42 case reports of hepatoxicity.
The proposed wording to appear on UK product packaging is: “Warning: In rare cases, black cohosh may cause liver problems. Consult your doctor if you already have liver disease or become unwell while using this product.”
Professor Edzard Ernst, director of complementary medicine at the Peninsula Medical School, Universities of Exeter & Plymouth, said that only four of the case studies drawn upon by the investigation are such that any meaningful inferences can be drawn from them. “I understand that regulators have to err on the safe side, but I wonder whether this is not some overreaction as black cohosh has been used for a long time,” he said. Moreover, Professor Ernst said he was not aware of any specific research establishing a mechanism of action for black cohosh’s effect on the liver.
Bonnie - this is sabotage to scare people away from herbals. The National Institutes of Health research showed tremendous safety - more than for every other heb except milk thistle. I have had hundreds of clients taking the Phyto Pharmica brand, and have never seen a hint of elevated liver enzymes or toxicity.
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