UK herbal sector agrees black cohosh liver warning
regulator over labelling of black cohosh products with liver injury
warnings, and has asked it to review the safety data again next
The Medicines and Healthcare Products Regulatory Agency (MHRA) announced last month that it was introducing labelling of products containing the herb, which has a long history of use for menopause symptoms, following two reviews of the safety data.
Penny Viner, chair of the Herbal Forum, told NutraIngredients.com that a voluntary agreement with the MHRA that by the end of October, unlicensed herbal medicine products containing black cohosh should carry the following warning:
"Black cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice. Not suitable for patients with a previous history of liver disease."
She said that the MHRA had originally wanted the warnings to be in place by the end of August, but that the forum negotiated a longer lead time for its members to comply.
While the labels are to be used on products manufactured from now on, Viner said that manufacturers should supply labels to retailers who have existing stock to sell that does not carry the wording.
Although the MHRA's original communication was that labelling be voluntary, a spokesperson indicated to NutraIngredients.com that if there should be little uptake it would take steps to make the labels mandatory.
Since the main associations manufacturing and marketing black cohosh containing products are members of the Herbal Forum, it seems there will now be no need for such draconian action.
But despite the industry's compliance, the book on black cohosh is not closed.
Viner said that the forum has asked MHRA to review the data again next year, since it appears that the number of adverse events reported is not on the increase but if anything is decreasing.
She said the MHRA "has indicated that it will".
The MHRA's action in July coincided with a public safety statement from the European Medicines Agency (EMEA) on black cohosh.
A spokesperson for the EMEA told NutraIngredients.com that, as the body that evaluates medicines for human use, it does not have the jurisdiction to make warning labels on products mandatory. That she said is down to the regulatory bodies of individual countries.
Swedens' Medical Products Agency also issued a statement, pursuant to the EMEA opinion.
Barbro Gerden, a spokesperson for the agency and physician who has been involved in liver damage cases, said that warnings of the potential link between black cohosh and liver damage have been included on product information leaflets in Sweden for a number of years.
There are no plans to have warnings on the outside of products sold in Sweden at the present time, but discussions are underway on possibly strengthening the language used in the leaflets and requiring companies to describe the symptoms of liver damage.
The present furore in Europe comes five months after Australia's Therapeutic Goods Administration made warnings mandatory on black cohosh products sold within its bailiwick.