The move follows precautionary advice from the European Herbal Medicinal Products Committee and from the UK Herbal Medicines Advisory Committee. Both these committees concluded that that the perceived benefits of the use of echinacea in children under 12 years were outweighed by the potential risks in this age group and that there was a low risk of allergic reactions but that these could be severe.
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.
The MHRA said that children aged 12 years or over and adults could 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, the agency said.
The licences of four echinacea products registered or licensed for children aged under 12 years have been updated in line with this new advice. The MHRA is requesting that unlicensed products also be relabelled and advises parents and carers not to use them in children under 12 years.
The MHRA’s head of herbal policy Richard Woodfield said the measures being taken were precautionary in nature.
‘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,’ he said. ‘Parents should not worry if they have given Echinacea to children under 12 in the past.’
The MHRA advised anyone with concerns to speak to their doctor, pharmacist or qualified healthcare practitioner.