Children below the age of 12 should not take Echinacea

The popular anti-cold and flu herb, Echinacea, should not be given to children under the age of 12 due to potentially "severe" allergic reactions. This is the official opinion of the UK medicine regulator, MHRA.

'This is not a serious safety issue, but parents and carers need to be aware that children under 12 could have a low risk of developing allergic reactions, such as rashes from oral Echinacea products. The measures being taken are precautionary in nature. Parents should not worry if they have given Echinacea to children under 12 in the past. Anyone who has concerns should speak to their doctor, pharmacist or qualified healthcare practitioner.' (Richard Woodfield, Head of Herbal Policy - Medicines and Healthcare products Regulatory Agency (MHRA))

Current situation

The product information for authorised Echinacea products lists the following allergic reactions: rashes, hives, swelling including swelling of the skin due to fluid and swelling of the face, difficulty breathing, asthma and life threatening anaphylactic shock.

Effects of this advice

A side effect of this warning is that the agency has to update two products, currently registered under the EU Traditional Herbal Medicinal Products Directive (THMPD) - Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets.

Echinaforce Tablets and Echinaforce Echinacea Drops also have to be relabeled. 'Current stock will be over-labelled and the new labels will state clearly that the products should not be used in children under 12 years.' The MHRA also warned of an 'unknown number of unlicensed Echinacea products on sale in the UK.' These products are also to be relabeled and the MHRA advises parents and carers not to use them in children under 12 years.

Low, but severe risk

According to the MHRA the advice came from the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC). The MHRA said the potential severity of the allergic reactions warranted the alert, even though the risk of allergic reactions in children was low. 'Children aged 12 years or over and adults can continue to use oral products containing Echinacea. Risks of side effects in older children and adults are reduced because they weigh more and in general catch fewer colds,' it said. The European Herbal Medicinal Products Committee (HMPC) advice on the matter can be found here

Information on the Traditional Herbal Registration (THR) Scheme can be found here.

Information on the herbal products registered under the Traditional Herbal Registration (THR) Scheme can be found here. (THR)