HerbalEGram: Volume 9, Number 9, September 2012

On August 20, 2012, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) advised parents not to use echinacea products in children under the age of 12 and also required manufacturers to re-label their echinacea products with the advisory warning.¹ The Irish Medicines Board has issued the same warning.² The decision is being denounced by various herbal medicine groups and a major manufacturer of echinacea products, which they say have been used safely in children for numerous years.^2,3

MHRA is the UK Department of Health agency responsible for ensuring safety and efficacy of medicines and medical devices.¹ In a press release, MHRA stated that its advisory on echinacea (Echinacea spp.) was based on conclusions from the European Herbal Medicinal Products Committee (HMPC), an EU agency, and the UK Herbal Medicines Advisory Committee, an advisory body of the MHRA. These groups found 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.”¹ According to the MHRA press release, the documented adverse reactions — which authorized echinacea products in the United Kingdom already feature on their package information — include “rashes, hives, swelling including swelling of the skin due to fluid and swelling of the face, difficulty breathing, asthma and life threatening anaphylactic shock.”

Richard Woodfield, MHRA’s director of herbal policy, stressed in the press release that “this is not a serious issue,” and that the risk faced by children under 12 is “low.”¹ Even considering the precautionary nature of the advisory, that any warning was issued at all is proving incomprehensible for many involved parties.

Scientist Roland Schoop of A. Vogel Bioforce AG, which manufactures the popular Echinaforce^® line of products, pointed out that the adverse events listed by MHRA in its press release are rarely observed and “should be considered in the light of the estimated number of courses of treatment, more than 10 million annually” (email, August 24, 2012). (A peer reviewer of this article noted that such evidence is impressive considering the mandatory adverse event reporting required of a high proportion of EU medicinal products, including echinacea products registered as traditional medicinal products and those that are fully authorized as medicines.)

“If compared with the thousands of deaths attributed to over-the-counter anti-inflammatory drugs or decongestants,” said Schoop, “the safety of Echinaforce appears very favourable.”^4,5 Other review papers also have concluded that echinacea is essentially safe.^6,7

A director of the European Herbal and Traditional Medicines Practitioners Association echoed Schoop’s sentiments, telling the Daily Mail that “the new guidance was ‘arbitrary’ and not based on any new research.”³ The president of the Irish Association of Health Stores (IAHS) told The Irish Times that children have been safely using echinacea products in Ireland for about 20 years, that “there was ‘no up-to-date evidence’ to show the product was unsafe for use by” children under 12, and that “there might be more sense in banning the sale of peanuts.”²

Schoop — whose 2006 echinacea meta-analysis was selected as one of the top 25 research papers by the US National Institutes of Health Office of Dietary Supplements⁸ — said that MHRA’s warning is surprising and irrational. According to a Bioforce press release, MHRA based its decision on the 2008 HMPC monograph even though section 4.4 of the monograph “explicitly states that ‘specific risk in children over 1 year of age is not documented.’”⁹

“While the clinical evidence on echinacea in children might be sparse,” said Schoop, “there exists a tremendous experience on the use of echinacea/Echinaforce in children [for] over 50 years.”

Many European countries already recommend that echinacea products state the potential of allergic reactions in those who have known allergies to plants in the Asteraceae family (also known as Compositae) or who have genetic dispositions to develop allergic reactions.

“The MHRA recommendation substantially diverges from newer recommendations from the European Scientific Cooperative on Phytotherapy or by Health Canada,” said Schoop. “Countries like Switzerland, Canada, Croatia, Australia, but also Germany and Austria today acknowledge the use of echinacea in children.”

The moves on echinacea as an “herbal medicinal product” in Europe may be seen as part of a wider pressure on regulators across the world, including in the United States, to restrict the use of medicines in children under 12, in response to the paucity of clinical trial and safety data on conventional medicine dossiers.

The MHRA/IRB decision on echinacea warning applies primarily to over-the-counter echinacea medicines, which make up the vast majority of echinacea products sold to the public, said Simon Mills, herbal practitioner and advisory board member of the American Botanical Council. It may have less impact on trained herbalists, who can prescribe patients echinacea preparations after conducting personalized consultations including routine screenings for atopic sensitivities, allergies, and asthma, he added (email, September 4, 2012).

“It is only advice, not a legal instruction or ban,” said Mills. “Herbalists can take a decision based on their experience and standards of practice, to take professional responsibility for their use of echinacea in children. I reckon most will choose to carry on as before.”

American Botanical Council Founder and Executive Director Mark Blumenthal pointed out MHRA’s failure to distinguish the important differences between echinacea products using the roots of the plant and those using the aerial (above-ground) parts.

“Any reactions that may be reported,” said Blumenthal, “are most likely associated with echinacea preparations containing aerial parts of the plant (e.g., dried leaves and/or flowers, or fresh-pressed juice), which may contain pollen, thereby possibly causing a reaction in a highly sensitized individual. Such reactions are probably very seldom, if ever, associated with alcoholic (ethanol) echinacea preparations made from echinacea roots only, as such preparations rarely, if ever, contain pollens. Further, its probable that the alcohol in extracts of either roots and/or aerial parts would most likely inactivate any pollens.”

Manufacturers of echinacea products available on the UK market are currently in the process of labeling products with the new advisory and over-labeling products currently on the shelves.


—Lindsay Stafford Mader


References

1. Echinacea herbal products should not be used in children under 12 years old: MHRA [press release]. London, England; Medicines and Healthcare products Regulatory Agency. August 20, 2012. Available at: www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627.

2. Ahlstrom D. Echinacea 'unsuitable for children’. The Irish Times. August 20, 2012. Available at: www.irishtimes.com/newspaper/breaking/2012/0820/breaking48.html. Accessed August 24, 2012.

3. Bates C. Echinacea could trigger allergies in children under 12, UK drugs watchdog warns parents. Daily Mail online. August 20, 2012. Available at: www.dailymail.co.uk/health/article-2191024/Echinacea-trigger-allergies-children-12-warns-UK-drugs-watchdog.html#ixzz24UMr3nMI. Accessed August 24, 2012.

4. Barrett B. Medicinal properties of echinacea: a critical review. Phytomedicine. 2003;10(1):66-86.

5. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA. 1999;281(9):824-829.

6. 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.

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

8. Bioforce receives American Botanical Council’s Tyler award [press release]. Austin, TX: American Botanical Council. March 5, 2012. Available at: http://cms.herbalgram.org/heg/volume9/03March/2012VETaward.html?t=1331247049.

9. Schoop R. Statement from Med. Dept. A. Vogel Bioforce AG on the MHRA and IMB’s advise on the use of Echinacea in children below 12 years [press release]. Bioforce AG. Unpublished. Sent to LS Mader from R Schoop. August 24, 2012.