A.Vogel Blog

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Echinaforce® for children under 12

by Alison, on 21 August 2012, Cold & Flu, Echinacea, Health, Herbal Remedies
echinacea-flower

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on the 20th of August that echinacea should not be taken by children under 12 years of age because of an association with a ‘low risk of allergic reactions’.

However, the MHRA has indicated that ‘this is not a serious safety issue’ and that ‘parents should not worry if they have given Echinacea to children under 12 in the past’. This announcement affects all echinacea based products (both licensed and unlicensed) and not just A.Vogel’s Echinaforce®.

Echinaforce® Echinacea drops and tablets have been available to consumers in the UK for over 25 years. During this time, and in common with other countries within the EU as well as Switzerland, Echinaforce® has been taken by children under the age of 12 years.

A.Vogel accepts that the law for medicines in each country is determined by its specific medicines regulator and that it is the responsibility of each to decide how a medicine can be used. Hence, although one country might allow use of echinacea in children under 12, it is the right of the MHRA to advise against this use in the UK.

Although we disagree with the MHRAs position, to remain within UK law, we have no choice but to comply and will change the dosage instructions on our packaging.

However, we felt that it was important for consumers to understand that, although the MHRA have made their announcement today, the advice they are giving is based on old data, rather than any new information on side effects received:

  • The HMPC monograph (or more correctly, the European Medicines Agency, Committee on Herbal Medicinal Products monograph), used to justify the decision was published over 4 years ago in March 2008 and states that traditional use of echinacea for those under 12 years is not recommended. However, it also states that as a well-established use medicine, ‘specific risk in children over 1 year of age is not documented’ – in other words, there is no data on any specific risk when echinacea is used by children over the age of one
  • The one research paper suggesting that in very rare circumstances echinacea can be associated with allergies, was published in 2002. This paper, by Mullins, was not a controlled study and described 5 cases of adverse reactions in adults who were ‘atopic’, meaning that they were prone to conditions such as eczema, asthma and hayfever. It is clear that those suffering from ‘atopy’ can be more prone to allergies of all forms, and not just to Echinacea.
  • Bioforce (UK) operates a herb safety monitoring system subject to regular audits by the MHRA. This has existed for over 10 years and records complaints received from consumers as well as healthcare professionals in the UK and Ireland. Since 2003, we have received no reports of children under 12 experiencing allergic reactions to Echinaforce. There have been two cases of children taking accidental overdoses of Echinaforce Junior, both of which resulted in no symptoms developing.

In summary:

  • The MHRA advice is based on an EU monograph published in 2008, and not on any new studies or data, so our knowledge of the safety of taking echinacea has not changed in the past 4 years
  • The MHRA are advising that echinacea should not be used by children under the age of 12 as a precautionary measure, because of the risk of allergies
  • This announcement does not affect the use of echinacea in children older than 12 years old, or adults
  • Parents should not worry if they have given echinacea to their children under 12 in the past.

 

Reactions

  • Gary Samer

    As a natural health practitioner with 32 years experience, I’ve used Echinaforce with all 4 of our children starting around the age of 2 with no problems whatsoever and quite outstanding results. It’s legal and “safe” to pump all sorts of highly toxic poisons; from vaccines, flouride, formulas, medications into our children with no problems but god forbid we try a natural herb used for hundreds of years. I’ll continue to “read between the lines” and trust Nature!

    • Alison

      Thank you Gary. It’s nice to hear the voice of experience and reason! Many of us will be looking at our strapping, healthy offspring and wondering just why we are supposed to believe that giving them Echinacea wasn’t a good thing!

  • Carla Howells

    I have given both my daughters the tablet form and neither have developed any issues. I think the benefit far outway this issue.

    • Alison

      Thank you Carla – very sensible. Echinacea doesn’t trigger allergic reactions in large numbers of children – in fact it’s a tiny number. The possibility of a child reacting to all sorts of foods and drinks and herbs and topical applications is always there, and this is not an issue with Echinacea any more than with other foodstuffs or herbs. Also, an allergic reaction to Echinacea is immediate, so if a child has taken it previously with no ill effect then there is no allergy present.

  • Janet

    once again the big drug companies are trying to ban our use of even more herbal remedies and the government and GPs do nothing.

    • Alison

      Hi Janet,

      It’s certainly something that many people feel – that their choice of natural remedies is being eroded.

  • Josephine Raj

    I have been using Echinacea for a year now & it helped to clear the cold & flu,which i am glad to say! My doctor was not at all pleased that I refused taking the flu jab.The flu jab did not helped me in the past & it was sever in my case.Like this morning I was sneezing & I took the Echinacea 15 drops with water & hasn’t sneezed & felt so much better.This is the best product to use at any given time on any seasons,If the young children have allergies maybe they shouldn’t be given.If it was OK in the past that parents giving this product to children under the age 12,as long as there is no allergy reaction then it should be fine. What does others think?

    • Alison

      Hi Josephine,

      I agree. If a child hasn’t any allergies and/or has used Echinacea previously then there is unlikely to ever be a problem. If a child has allergies and is very sensitive to things generally then it may react to Echinacea – possibly. If lots of children were affected in this way then we would have the reports coming in all the time, and we have none!

  • LILIAN HULF

    Almost complete rubbish , Echinacea is safer to use then many ”normal” medicines…..
    Lilian Hulf

    • Alison

      Hi Lilian,

      Yes I agree. Our pharmacovigilance department (which deals with all safety issues with the herbs) very rarely has reactions reported even in adults, and we have had none with children.

  • Laurence

    This is a very serious development and I cannot help but suspect sinister undertones. Echinacea has been demonstrated to be one of the more effective herbs in assisting the immune system and if it is said that the benefits of flu vaccination is far greater than the side effects and associated risks I should like to know what the ratio of side effects of echinacea to benefit is and compare it to the flu vaccine statistics. I would suggest that the echinicea study would reveal far less complications and significantly more benefit. May be a study worth undertaking though I cannot see it being used as a cornerstone to inform policy! It would be interesting also to see sales figures for pharmaceutical flu remedies last year and compare them to echinacea sales and compare them to the forthcoming flu season figures. The timing for this announcement raises other questions too I think.
    I am very disappointed at this move and do not believe that it is based on adequate research. This is cherry picking, and not good science!!!

    • Alison

      Hi Laurence,

      I think your comments on the illogicality of this move are very valid. Some people will be allergic to it – any substance whatever has the potential of causing allergic reactions in at least one of the vast human population – but there have only been 9 reported cases of allergic reaction to Echinaforce products world wide, which is comforting when you consider how many millions of people take it regularly.

  • jenny brockhurst

    What a load of nonsense! I have always used echinacea for my children..no bad side effects..only positive. Its a marvellous aid to those who don’t want to troll off to the quacks and get whatever ghastly drug is on offer….and risk side effects from those. Ridiculous!

    • Alison

      Hi Jenny,

      Thank you for your very sensible comments. I agree totally!

  • sue

    Our right to use natural products is being eroded by stealth by big Phama and its political supporters. We have used it for a long time now. My grandchildren use it with no side effects – both are under 12. We have given it to the dogs as they had suspected kennel cough with great success. We keep as far away from mainstream medicine as we can.

    • Alison

      Thank you for your sensible comments Sue. So many of us have used Echinaforce for children that we feel slightly bewildered by this claim.

  • Janine Parkinson

    Thank you for this well-balanced piece of information. I was brought up by a family of Drs and nurses who believed that (almost) everything could be cured in a natural way, and we seem to have been OK. I have brought up my own children and grandchildren in the same way, and they have thrived. We tend to use the old-fashioned method of “common sense”. It works surprisingly well! However, I have no complaints about Echanicea, and first read about it in the very large but readable “The Nature Doctor” by Vogel. Excellent book…….. Keep up the good work everyone at BioForce – many of my friends are supporters….thank you.

    • Alison

      Hi Janine,

      Thanks for your support and your experience. I love reading the Nature Doctor – full of common sense, which is often distressingly uncommon these days!

  • mary kennedy

    Has anyone ever questioned the side effects of giving antibiotics, antihistamines, steroids etc etc to children under 12???

    • Alison

      Hi Mary,

      Hopefully the MHRA is turning its attention to some of these items as well as to herbal remedies. They aren’t just singling out Echinacea but are looking at many medications that have up to now been given to children under 12. Like you, I hope that this will lead to less medicating of children and possibly a more common sense approach involving decent diet, exercise, and regular hours of sleep!

  • andrea

    As a mum of 3 children, two with milk allergies as babiesand one who became allergic to everything that had colour in it because of a pharmaceutical medicine for worms; I turned to natural medicines and have used echinacea sucessfully with all of them with no effects and according to the research they would be the group effected as they have had ecema, hayfever and one asthma however I would like to say that when I have used echinacea it worked marvelously and I would recomend that other parents use it.

    • Alison

      Thanks Andrea, it’s very good to hear the voice of common sense and the actual real life experience of some of the millions of parents who use Echinacea.

  • Sue Schubert

    I agree with everybodys positive comments. It’s good to see parental common sense being used.
    It’s more likely the children bought up in a sterile, antibacterial, visit the doctor for a sniffle, pill-popping, plug-in air freshener world who have a reacction to something natural – it comes as a shock to their systems.
    I have given my daughter Vogal echinacea before and the only reaction was ‘it tastes like grass’
    More power to your elbow Alison!

    • Alison

      Hi Sue,

      Thanks! I do so agree – plug in air fresheners make my nasal passages cringe! I think parents will find this very puzzling!

  • Kath at Wholesome Bee

    Trying to ‘ban’ a medicine or drug, herbal or not, does not always stop people taking it, it just alters where they get it from. By targeting children the pharmacutical driven organisations (MHRA in this case) are scaremongering parents, using political power to their own ultimate gain. How sad. Everything, and more so in politics EVERYBODY it seems, can be bought.

    • Alison

      Hi Kath,

      Thanks for your comments. Yes, it is a real shame to raise fears amongst parents. I’m glad you find Echinacea a useful remedy.

  • Breda Sneddon

    I find this current scaremongering horrific and hypocritic. I have just had the pleasure of reviewing reports from trials on a pharmaceutical drug which directly caused the deaths of a number of people within a few months of starting treatment and has continued to cause deaths including in other trials and even after the treatment has been withdrawn. Allergic reaction to the drug is possible and severe allergic response is rare – but as with anything we take internally or put on our skin it is possible! New trials are continuing on this drug even after 10 years of people dying as a side effect. Yet the answer there is to change the name of the drug. Get the botanists out, can we change the name of Echinacea?

    • Alison

      Hi Breda,

      What a smashing idea! We could call it after Black Elk, who generously shared it with Vogel. That would reflect its long and proud heritage.

  • Maureen

    I have given my child Echinacea to build up her immune system for many years now with no side effects whatsoever…
    I disagree 100% with the views of the MHRA…
    Yet another rule purely to reduce customer choices…worrying development!!!

  • Carol

    Possibly another propaganda campaign by the pharmaceutical syndicates to put herbal companies out of business!!!

  • Nic

    Thank you for such a succinct and helpful response to the new guidelines. As a holistic therapist, I freely admit I tend to use my instinct and experience rather than following government advice and agree with all the comments below that this latest effort is ridiculous. It simply appears to be yet another example of the government/pharmaceutical companies trying to scaremonger and encourage the use of their, often, more dangerous products than relying on Mother Nature.

  • Andy

    I’ts about time all the Large Drug Companies started to elimiate all the bad side effects
    from their drugs & leave the herbal remedies alone.

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