UK-based herbal supplements manufacturer A. Vogel says a recent medicines agency ruling that anti-cold and flu herb echinacea should not be sold to children under the age of 12 was based on outdated data.
The Medicines and Healthcare products Regulatory Agency (MHRA) made the ruling based on the potential for, “low risk of allergic reactions” even as it acknowledged that, “This is not a serious safety issue…”.
Responding, A. Vogel said the ruling did not reflect the current understanding of echinacea.
“Although we disagree with the MHRAs position, to remain within UK law, we have no choice but to comply and will change the dosage instructions on our packaging,” the company said.
“However, we felt that it was important for consumers to understand that, although the MHRA have made their announcement today, the advice they are giving is based on old data, rather than any new information on side effects received…”.
A. Vogel noted:
- The monograph used to justify the MHRA decision was published in March 2008 and states that traditional use of echinacea for those under 12 years is not recommended. However, it also states that as a well-established use medicine, ‘specific risk in children over one year of age is not documented’ – in other words, there is no data on any specific risk when echinacea is used by children over the age of one.
- The one research paper suggesting that in very rare circumstances echinacea can be associated with allergies, was published in 2002. It was an uncontrolled study and described 5 cases of adverse reactions in adults who were prone to conditions such as eczema, asthma and hayfever.
- Since 2003, the company has received no reports of children under 12 experiencing allergic reactions to echinaforce (its echinacea product).
“The measures being taken are precautionary in nature. Parents should not worry if they have given echinacea to children unde r 12 in the past. Anyone who has concerns should speak to their doctor, pharmacist or qualified healthcare practitioner,” the MHRA said when it issued its warning in late August.
The warning means the agency has to update two products that had been registered under the EU Traditional Herbal Medicinal Products Directive (THMPD) - Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets.
A. Vogel agreed to over-label Echinaforce Tablets and Echinaforce Echinacea Drops to compy with the MHRA.
The agency also warned of an, “unknown number of unlicensed echinacea products on sale in the UK.”
The MHRA said it had followed the advice of the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC) in issuing the warning.