Echinacea for children and the MHRA

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In Britain the Medicines and Healthcare Products Agency,  the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, have issued a warning that Echinacea products should not be given to children under the age of twelve years. This was widely announced by the press. In the past the MHRA have held discussions with the Professional herbal practitioner bodies before implementing any such regulation, but not on this occasion. This is a worrying development which will result in a lack of balanced information needed to formulate appropriate regulation. I have used Echinacea products with all age groups for over twenty years without a single adverse report.

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Professional herbal practitioners screen for allergies and any likely contraindications or interactions with their patients so this is the common experience across the profession. The previous position, of no warnings required, was supported by research like a systematic review, based on clinical studies, case reports and surveillance programmes of national medicines regulatory authorities. The World Health Organisation concluded, for example, that Echinacea products have a good safety profile when taken in the short term.  This review also observed that “if adverse events associated with Echinacea occur they tend to be transient and reversible”.[1]  In addition, the European Medicines Agency refers to a paper by Freeman and Spelman that states “Given our findings, the estimated risk of taking echinacea products (1 in 100,000), the number of echinacea doses consumed yearly (> 10 million), the number of adverse events (< 100) and that the majority of use is short term, E. purpurea products (roots and/or aerial parts) do not appear to be a risk to consumers.”[2] 

 

The questions that come to mind are what has changed since and why has discussion not taken place? From my perspective, given the present evidence, I do not see any appreciable risk to the health of children by taking Echinacea products from a professional herbalist.

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UPDATE

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I am happy to report the MHRA has updated their warnings/restrictions on the use of the herb Echinacea with children under 12 years of age and after exchanges with the herbal professional bodies; the Medicines and Healthcare products Agency have now clarified the situation:
“In relation to continued practitioner use of Echinacea in children under 12; this would be for the individual practitioner to decide in full consultation with their clients.”

 

 

[1] Huntley AL, Thompson Coon J, Ernst E. The safety of herbal medicinal products derived from Echinacea species: a systematic review. Drug Saf 2005, 28: 387-400.

[2] Freeman C, Spelman K. A critical evaluation of drug interactions with Echinacea spp. Mol Nutr Food Res. 2008 Jul;52(7):789-98.

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Echinacea also has research suggesting it is safe to take during pregnancy:

Perri D, Dugoua JJ, Mills E, Koren G. Safety and efficacy of echinacea (Echinacea angustafolia, e. purpurea and e. pallida) during pregnancy and lactation. Can J Clin Pharmacol. 2006;13(3):e262-e267.