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Following its recent assault on herbal products containing black cohosh (Cimicifuga [Actaea] racemosa) and butterbur (Petasites hybridus), the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has turned its attention to the use of Echinacea products by the under-12s.  Is it an early shot across the bows that signals a wider assault on herbal products?

MHRA: "Echinacea risks outweigh benefits"

According to the MHRA’s press release, it now recommends that children under 12 years of age should not use oral herbal medicinal products containing Echinacea, which are popularly used to treat colds and flu.  Apparently, “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.”  The Irish Medicines Board (IMB) quickly followed suit


The MHRA/IMB decision has been criticised by herbalists’ organisations in the UK and Ireland, bloggers and both UK and Irish retailers, and a petition calling for the MHRA to reverse its advice has been set up.  With regard to the latter, we must point out that there is no suggestion yet of Echinacea being ‘banned’: the MHRA/IMB is merely advising parents not to give it to children under 12, and products are being relabelled accordingly.

Hunting high and low

Although mute on the basis of its decision, the MHRA/IMB appear to have jumped on the findings of a single study, reported in a Cochrane review on Echinacea for preventing and treating the common cold.  People, especially children, suffer allergies from natural substances found in their environment.  But allergies to members of the daisy family (Asteraceae/Compositae), which include Echinacea, ragweed, chrysanthemum, marigold and daisies, are rare – and they are not severe.  They are simply mild skin rashes.  Owing to the lack of adequate studies, the Cochrane review also finds inadequate evidence of benefit in children, while recognising a benefit in adults.  This is counter to decades of clinical experience, and is much more likely a function of the number and quality of studies in children, that are generally considerably harder to gain ethics approval for.


We’re presently waiting for a reply to a series of questions to the MHRA, including whether it made its decision in response to additional cases of adverse reactions to Echinacea in children under 12, and we’ll update you when we know more.  For supporting evidence, the MHRA points interested punters, such as ourselves, to the European Medicines Agency’s (EMA’s) database of information on herbal medicines for human use


Table 1 below is a compilation of the relevant safety data from the various EMA monographs on Echinacea and the corresponding assessment reports by the Human Medicinal Products Committee (HMPC).

Table 1.  Data relevant to safety of various Echinacea species and parts as held on European Medicines Agency (EMA) database

Echinacea species and form

EMA monograph

HMPC assessment report

Date updated

E. purpurea aerial parts


Contraindications: people with sensitivity to Echinacea’s botanical family, the Asteraceae/Compositae; infants under 1 year old; progressive systemic disorders, autoimmune diseases, immunodeficiencies, immunosuppression and diseases of the white blood cell system Use in children aged 1–12 years of age: “Not recommended because efficacy has not been sufficiently documented”

As per monograph.


From conclusion: “In view of the results of the preclinical toxicological studies, clinical trials and of several decades of experience of its use in human beings, the expressed juice of Echinacea purpurea can be classified as a safe and well tolerated drug

5th March 2008

E. purpurea root


Contraindications: Hypersensitivity to the active substance or to plants of the Asteraceae/Compositae family


Not recommended in cases of progressive systemic diseases such as tuberculosis, diseases of the white blood cell system, collagenoses multiple sclerosis, AIDS, HIV infections and other immune diseases


Possible risk of allergic reactions in sensitive individuals, and of anaphylactic reactions in atopic individuals


Use in children under 12 years of age has not been established due to lack of adequate data   

No contraindications listed. Other comments as per monograph


There are no sufficient data on safety of purple coneflower root preparations in children; therefore the use of Echinacea purpurea root and preparations thereof is not recommended


From conclusion: “A certain level of safety could be expected due to the long-standing use of Echinacea purpurea root preparations with no serious side effects reported”

Monograph: 28th January 2011


HMPC assessment: 10th February 2011

E. pallida root

Contraindications: Hypersensitivity to the active substance or to plants of the Asteraceae/Compositae family; progressive systemic diseases such as: tuberculosis, diseases of the white blood cells system, collagenoses, multiple sclerosis, AIDS, HIV infections, and other immune diseases; children under 12 years of age

No contraindications listed Not recommended in progressive systemic diseases such as: tuberculosis, diseases of the white blood cells system, collagenoses, multiple sclerosis, AIDS, HIV infections, and other immune diseases


There are no data on safety of pale coneflower preparations in children; therefore the use of herbal drug and preparations is not recommended


From conclusion: “A certain level of safety can be assumed due to the long-time use of Echinacea pallida preparations with no serious side effects reported”

16th July 2009

E. angustifolia radix (root)

Contraindications: Hypersensitivity to the active substance(s) and to other plants of the Asteraceae/Compositae family


Not recommended in cases of progressive systemic diseases such as tuberculosis, diseases of the white blood cell system, collagenoses multiple sclerosis, AIDS, HIV infections and other immune diseases


Possible risk of allergic reactions in sensitive individuals, and of anaphylactic reactions in atopic individuals


Use in children under 12 years of age has not been established due to lack of adequate data

Contraindications: Hypersensitivity to plants of the Asteraceae/Compositae family; progressive systemic diseases (tuberculosis, sarcoidosis), autoimmune diseases (collagenoses, multiple sclerosis), HIV infection, AIDS, haematological diseases (agranulocytosis, leukemia); serious hepatic diseases; epilepsy; pregnancy and lactation


Use in children under 12 years of age has not been established due to lack of adequate data


From conclusion: “Although toxicological data are limited, a certain level of safety could be expected due to the long-standing use of Echinacea angustifolia root preparations with no serious undesirable effects reported

29th May 2012


Safe as houses

It’s crystal clear from the data in the table that Echinacea is a remarkably benign substance: it’s been used for a long time, by thousands upon thousands of people, with – to quote the EMA’s own documents, and by extension the MHRA/IMB – “No serious undesirable effects reported”.  None of the documents have been recently updated with damning new information on Echinacea’s supposedly perilous effects on children under 12.  Where Echinacea is not recommended for those children, it’s due to a lack of data and not safety concerns.  And it’s anyone’s guess why the EMA monograph for E. pallida cites children under 12 as a contraindication: statements in the monograph are not individually referenced, although a list of references is provided, and the HMPC assessment report says nothing about a contraindication.  Either way, E. pallida is not widely available on the UK or Irish marketplace.


These data show us that hypersensitivity reactions to Echinacea are extremely rare, much rarer in fact than similar reactions to common foods widely distributed in the European marketplace, such as dairy, wheat and peanuts.  To be logically consistent with its stance on Echinacea, a regulator would have to ban these foods and not just issue a recommendation to restrict their use – which, let’s face it, isn’t going to happen.  A far more realistic way around the problem is for manufacturers to include an allergy warning on the labelling and/or product insert, something the larger manufacturers, at least, already do. This is much preferable to issuing a warning that denies the vast majority of a given population group, in this case children under 12, use of a product that so many have benefited from over so many years.

Testing the waters

We suspect that the MHRA and IMB are ‘testing the waters’ with their decisions.  Because Echinacea is so popular, with clearly beneficial effects in upper respiratory tract infections including colds and flu – and a direct competitor to children’s medicines like Calpol which, unlike Echinacea, don't actually address the immune system itself – the MHRA and IMB may feel emboldened in their apparent crusade against herbal products if no public outcry occurs (see our ‘Call to Action’, below). 

In that case, we wouldn’t be at all surprised if the MHRA and IMB then acted to actively ban Echinacea products that are sold as food supplements.  Their likely justification would be that Echinacea products pose both a danger to children, and, citing the Cochrane finding, are therapeutically active only in adults.  This would give the regulator the power to declare Echinacea food supplements or teas to be ‘unlicensed medicines’.  And it would force their removal from the market.  This would leave only the registered medicine versions, precisely what many who have spent significant amounts of money registering products have wanted all along.


We don’t want that to happen, and we’re sure you don’t either.  So let’s give the MHRA/IMB the public outcry that will stop it in its tracks!  See our ‘Call action’ below for how to get involved.

Call to action

  • If you live either in the UK or Ireland,  you may wish to endorse our letter about the issues and send your endorsement to the MHRA or IMB, depending on where you live.  Even better, use our letter as a jumping-off point to write your own.  If you’ve seen your under-12s benefiting from use of Echinacea, make sure you tell these regulators. They appear to be presently convinced that Echinacea lacks efficacy in children.  Please copy us into your correspondence (at [email protected]) and send your letters by email to Richard Woodfield at the MHRA ([email protected]) or to John Lynch at the IMB (he[email protected]).  Alternatively, you can post hard copies to the following addresses:

Richard Woodfield

Head of Herbal Policy

Medicines and Healthcare products Regulatory Agency

151 Buckingham Palace Road

London

SW1W 1SZ

Or:

John Lynch

The Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earslfort Terrace

Dublin 2

Ireland

  • If you’re a retailer of Echinacea products, or a parent considering giving them to your under-12 kids, our advice is to just carry on as before — following the directions on the label!  If your child was one of those very few that showed allergic skin reactions to the daisy family, you would know about it by now and have stopped them from taking it!  The MHRA/IMB recommendation, which will undoubtedly filter through to product labeling in due course, is just that – a recommendation that carries no legal weight

 We'll be sure to keep you posted on the response to our letter to the MHRA.


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