Middle-aged women warned against buying unlicensed herbal menopause treatment
Concerned: The MHRA said the pills contain 50 times the approved dose for treating menopausal symptoms
People are being warned against buying a potentially dangerous herbal product for treating symptoms of the menopause.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety notice over FSC (Food Supplement Company) Black Cohosh 1000mg capsules.
The MHRA said the pills – an unlicensed herbal remedy – contain 50 times the approved dose for treating menopausal symptoms and do not have the necessary authorisation as a medicine.
It has asked the manufacturer to remove the product from the market after experts also found it carried poor labelling relating to safety information and side effects.
The pills can currently be bought in health food shops and online.
According to MHRA figures, 50 reports of suspected adverse reactions linked to various unlicensed black cohosh products have been received since 1998.
They have included some people suffering jaundice, liver problems and hepatitis.
Some black cohosh products have a traditional herbal registration (THR) and come with a patient information leaflet detailing correct use of the product and describing potential side effects.
The MHRA is recommending people use these registered herbal medicines, which can be identified by a THR registration number on the packaging.
Most products will also display the THR logo.
Head of herbal policy, Richard Woodfield, said: “This alert highlights the importance of using a registered product.
“If the product is not a THR there has been no guarantee relating to the safety or quality of the product.
“Reading the patient information leaflet ensures that you are aware of the correct way to take a medicine, the potential side effects as well as any possible interactions with other medication you may be taking.
“An unlicensed herbal product 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 qualified healthcare professional.”