Unregistered menopause remedy prompts MHRA warning
Drug safety MHRA officials have urged consumers to remember that "natural does not always mean safe" after the agency issued a safety notice for an unlicensed black cohosh herbal remedy.
MHRA officials have urged consumers to remember that "natural does not always mean safe" after the agency issued a safety notice for an unlicensed black cohosh herbal remedy.
FSC Black Cohosh 1,000mg capsules are used to relieve menopausal symptoms and have been available online and through independent health food shops.
The MHRA has asked the manufacturer to remove the product from the market because it is not authorised as a medicine and contains 50 times the approved dose for menopausal complaints.
The product also has insufficient labelling detailing safety information and side-effects, the MHRA has said.
The MHRA said the public should take care to buy registered herbal medicines only. It added that registered black cohosh products bearing a traditional herbal registration (THR) number and logo are available. These have been quality checked and assessed for safety and are supplied with a public information leaflet providing information about the correct use of the product as well as information on potential side effects.
MHRA head of herbal policy Richard Woodfield explained an unlicensed herbal product may have incomplete, inaccurate or no safety information. "You are gambling with your health, especially if you take these products without consulting a GP or qualified healthcare professional," he said.
The MHRA claims to have received as many as 50 suspected adverse reaction reports associated with various unlicensed black cohosh products since 1998, with reactions including jaundice, liver problems and hepatitis.
Find out more about the traditional herbal registration scheme and what it means for you with C+D's guide and video interview with Richard Woodfield.