He told British consumers: “If you think you have suffered a side effect from these products, tell us through our reporting system called the Yellow Card Scheme.” The system can be reached through its website, www.mhra.gov.uk/yellowcard.
So far, there’ve been no adverse drug reactions reported in the UK. But cases of liver toxicity have been linked with these products in Europe, the MHRA said.
The regulator also issued a letter to the UK herbal industry asking herbal shops to remove these “unlicensed” products from their shelves. There are no licensed butterbur products in the UK, and these are prohibited or restricted in a number of other European countries, the agency said.
Traditional herbal registration scheme
Because it’s unlicensed, standards of safety and manufacture in the UK’s herbal sector vary widely. Seeking to ensure the safety of British consumers of herbal products in this setting, MHRA introduced the traditional herbal registration scheme in 2005.
Under this scheme, manufacturers of over-the-counter traditional herbal medicines are required to meet standards of safety, quality and patient information.
Currently, under this scheme, there are no products containing butterbur licensed for use in the UK, the MHRA said explicitly in a press statement. But it was aware that many butterbur products were still are being marketed in the UK, it said.
While asking herbal shops to pull the butterbur product off their shelves, it also advised consumers: “When looking for herbal medicines, you should look for herbal products that have a traditional herbal registration or a product license; so that you can be confident the product has been assessed as meeting appropriate safety standards, and has the necessary patient information.
“Products with a traditional herbal registration can be identified by a THR number on their label,” Woodfield explained. “This means that the product has been assessed by the MHRA so that consumers can be confident that its quality can be assured and that is accompanied by the necessary information about how to use the product safely,” he said.
In the past, the MHRA has issued a number of warnings about unlicensed herbal medicines and Traditional Chinese medicines.
“We will continue to take regulatory action against herbal medicines not marketed within the Traditional Herbal Registration Scheme,” the Herbal Policy chief vowed.
Butterbur Side Effects was originally published 18 February 2012. Updated 3 October 2016.