|Date:||Monday 20 August|
|Subject:||Echinacea herbal products should not be used in children under 12 years old|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) today advised parents and carers not to use oral herbal products containing Echinacea for children under 12 years of age. Children aged 12 or over and adults can continue to use herbal products containing Echinacea.
This move by the MHRA follows precautionary advice from the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC). They both concluded that the perceived benefits of the use of Echinacea in children under 12 years are outweighed by the potential risks in this age-group and there is a low risk of allergic reactions but these could be severe. 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.
Two Echinacea products (Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets) were registered under the Traditional Herbal Registration (THR) Scheme for children aged between six and 12 years as well as for older children and adults. These products have been updated in line with this new advice and newly labelled products will be available in due course. 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.
In addition, there were two oral Echinacea products (Echinaforce Tablets and Echinaforce Echinacea Drops) with product licences for children aged between six and 12 years. The labelling of these products is also being updated in line with this advice and existing stocks will also be over-labelled.
However, there is an unknown number of unlicensed Echinacea products on sale in the UK. The MHRA is requesting that these products are also relabelled and advises parents and carers not to use them in children under 12 years.
Richard Woodfield, the MHRA’s Head of Herbal Policy, said:
“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 MHRA is working with the herbal sector to ensure that all oral Echinacea products are re-labelled with a warning that they should not be given to children under 12. 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.”
Notes to Editor
1. 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.
2. The two products with product licences are called:
Echinaforce Tablets (PL 13668/0001) and
Echinaforce Echinacea Drops (PL 13668/0002)
And the two products with traditional herbal registrations are called:
Echinaforce Junior Cold & Flu Tablets (THR 13668/0015) and
Echinaforce Chewable Cold & Flu Tablets (THR 13668/0025)
3. Information on the advice from European Herbal Medicinal Products Committee (HMPC) can be found here: Herbal medicines for human use (external link)
4. Information on the Traditional Herbal Registration (THR) Scheme can be found here:
Herbal medicines regulation: Registered traditional herbal medicines
5. Information on the herbal products registered under the Traditional Herbal Registration (THR) Scheme can be found here: List of products granted a Traditional Herbal Registration (THR)
6. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Our work is underpinned by robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk