The Medicines and Healthcare Regulatory Agency (MHRA) has warned consumers about the dangers of unlicensed Black Cohosh remedies after a woman suffered serious liver failure when she took an unnamed product containing the herb. The woman subsequently required a liver transplant.
An investigation into the case and the product involved is ongoing.
The MHRA says it has received 53 reports of adverse reactions “suspected to be associated with the use of Black Cohosh” through the Yellow Card safety reporting system.
In a statement the MHRA urges consumers to choose herbal products licensed under the Traditional Herbal Registration scheme and to look for the THR logo on packs. THR products are required by law to provide comprehensive safety information – including, in the case of Black Cohosh, warnings to people with liver conditions not to take the product. Although since 2006 the Agency has asked manufacturers of all Black Cohosh products to ensure that appropriate safety warning is included in packaging, it says that some manufacturers have ignored the advice.
The MHRA told the Daily Mail that the agency had also found Black Cohosh being sold as a food supplement at 50 times the recommended dose.
Richard Woodfield, the MHRA’s head of herbal policy, said: “Unlicensed herbal medicines may have incomplete, inaccurate or no safety information and can mean you are gambling with your health, especially if you take these products without consulting a GP or a qualified healthcare professional.”
One industry insider told Natural Products: “We have been predicting this situation for years as it has been known that some manufacturers and suppliers have been selling high dose unregulated material with major health implications. We are now perilously close to losing another wonderful herb because of money-crazed companies who know nothing about herbal medicine or medical ethics.”
