Echinaforce for children under 12
The Irish medicines regulator, the Irish Medicines Board (IMB) announced on the 20th of August that echinacea should not be taken by children under 12 years of age because of an association with ‘rare side effects, mainly allergic reactions’.
However, the IMB has indicated that ‘this is not a serious safety issue’ and that ‘the measures being taken are precautionary’. This announcement affects all echinacea based products (both licensed and unlicensed) and not just A.Vogel’s Echinaforce®.
Echinaforce® Echinacea drops and tablets have been available to consumers in the Ireland for nearly 20 years. During this time, and in common with other countries within the EU as well as Switzerland, Echinaforce® has been taken by children under the age of 12 years.
A.Vogel accepts that the law for medicines in each country is determined by its specific medicines regulator and that it is the responsibility of each to decide how a medicine can be used. Hence, although one country might allow use of echinacea in children under 12, it is the right of the IMB to advise against this use in the Ireland.
Although we disagree with the IMBs position, to remain within Irish law, we have no choice but to comply and will change the dosage instructions on our packaging.
However, we felt that it was important for consumers to understand that, although the IMB have made their announcement today, the advice they are giving is based on old data, rather than any new information on side effects received:
- The HMPC monograph (or more correctly, the European Medicines Agency, Committee on Herbal Medicinal Products monograph), used to justify the decision was published over 4 years ago 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 1 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. This paper, by Mullins, was not a controlled study and described 5 cases of adverse reactions in adults who were ‘atopic’, meaning that they were prone to conditions such as eczema, asthma and hayfever. It is clear that those suffering from ‘atopy’ can be more prone to allergies of all forms, and not just to Echinacea.
- Bioforce (UK) operates a herb safety monitoring system subject to regular audits by the MHRA. This has existed for over 10 years and records complaints received from consumers as well as healthcare professionals in the UK and Ireland. Since 2003, we have received no reports of children under 12 experiencing allergic reactions to Echinaforce. There have been two cases of children taking accidental overdoses of Echinaforce Junior, both of which resulted in no symptoms developing.
- The IMB advice is based on an EU monograph published in 2008, and not on any new studies or data. Our knowledge of the safety of taking echinacea has not changed in the past 4 years
- The IMB are advising that echinacea should not be used by children under the age of 12 as a ‘precautionary measure’, because of the risk of allergies
- This announcement does not affect the use of echinacea in children older than 12 years old, or adults
- Parents should not worry if they have given echinacea to their children under 12 in the past.