August 20th 2012 – The Irish Medicines Board (IMB) today advises that children’s herbal products containing echinacea will no longer be recommended based on the lack of scientific data to support their use. This new advice follows a review by the IMB of available data on the safety and effectiveness of echinacea and it is now advising that such products should not be used for children under 12 years of age. The IMB is communicating with retailers and others within the supply chain to inform them of this recommendation and to request that children’s echinacea‐containing products are removed from sale.

Adult echinacea herbal products are not affected by this recommendation. However, some adult product information includes information on children’s dosage. It is anticipated that new product information will change over the coming months to reflect this new advice. In the meantime, the IMB is recommending that adult echinacea ‐containing products are also not used in children.

The implementation of the European Herbal Medicines Directive in Ireland in 2011 prompted a review of previously unregulated herbal products on the Irish market. The IMB has considered all information available regarding safety and efficacy of echinacea products. The available safety data as well as guidance from the Committee on Herbal Medicinal Products of the European Medicines Agency (EMA) were evaluated. The IMB concluded that the use of echinacea can be associated with rare side effects, mainly allergic reactions, which in some cases may be severe.
Ms Ann O’Connor, IMB Director of Human Products Authorisation states, “This is a prudent measure which is being taken following evaluation of the data available. Our view is that there are potential risks associated with the use of echinacea‐containing products in children under 12 years of age and there is limited evidence of benefit in this age group.

As a result, we are recommending that they should no longer be used. It is important to carefully check the ingredient list on a herbal product and if it contains echinacea, it should not be given to children. This is not a serious safety issue, and the measures being taken are precautionary in nature. Parents should have no concerns if they have given echinacea to children under 12 in the past.”

“As with all medicines, the goal is to maximise the benefits of use and reduce the risks. Products containing echinacea are medicines and as such, they should be used with care. As with all medicines, we ask members of the public to report any suspected side effects to their healthcare professional or to us directly via our website” concludes Ms O’Connor.

IRH Response: We have contacted the IMB (and the MHRA in the UK who issued a similar statement) and asked to see the research and data they used to issue this statement. We will make a response in due course.

Update: A campaign has been launched to get the decision reversed. Petition here: