“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,” said Richard Woodfield, the MHRA’s Head of Herbal Policy
“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 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.
Echinaforce Tablets and Echinaforce Echinacea Drops will also be over-labelled.
“These products have been updated in line with this new advice and newly labelled products will be available in due course,” the Medicines and Healthcare products Regulatory Agency (MHRA) said.
“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 agency also warned of an, “unknown number of unlicensed Echinacea products on sale in the UK.”
It said these products should be relabelled and advised parents and carers not to use them in children under 12 years.
Low, but severe risk
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.
The potential severity of the reactions warranted the alert, even as it acknowledged 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.