MHRA: Echinacea May Be Unsafe for Children

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK recently cautioned consumers about the use of echinacea supplements in children under 12 years-old. The MHRA is a government agency that oversees the safety and effectiveness of medical devices and medicines in the UK.

Traditionally used for a range of infections and malignancies, the roots and herb of echinacea species have attracted scientific interest due to their purported immune stimulant properties. Oral preparations of echinacea are popular in Europe and the United States for the prevention and treatment of upper respiratory tract infections or the common cold.

The MHRA recommendation resulted from the conclusions of the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC). These committees reported that the risk of allergic reaction to echinacea is higher in younger children. The MHRA stated that echinacea is still safe for children over 12 and adults.

The products Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets will be relabeled to reflect this recommendation. The MHRA is working to relabel other echinacea products on the market.

For more information about echinacea, please visit Natural Standard's Foods, Herbs and Supplements database.

Comments

[AM]

Echinacea is part of the same family as ragweed. Kids who have severe asthma or seasonal allergies will have issues with echinacea. It's good to see that natural standard is bringing this to light.

[NL]

This was very helpful. Echinacea and products that contain it are often being asked about in the pharmacy for children and adults. I am apt to try to dissuade most patients from using it for cold prevention. Now I will have data to support my recommendation, especially in children.

[KS]

Echinacea has a Natural Standard evidence grade of B for treatment of upper respiratory tract infections in adults, but has a evidence grade of C for treatment in children, as well as prevention in both children and adults. This is really good information for retail pharmacists, who often get asked questions about natural products. Most people do not realize that there are any potential interactions or risks. I'm glad I read this so if a customer ever comes in asking about the efficacy of Echinancea in treating URTI, I can be sure to ask if it is for an adult or child before making a recommendation.

[nb]

The concept of "preventing" or "treating" a cold is somewhat misleading to me. Colds are spread via casual contact with bodily fluids of an infected individual. A few years back, AirBorne was caught in the middle of a huge law suit for claiming that it could prevent a cold. I think that while it was a good thing to take precaution and advise children under 12 to not take Echinacea, the manufacturers of the supplements should be cautious of what their claims are, so that it is not misleading for the consumers.

[nh]

Before reading this, I could not remember what Echinacea was used for and I certainly did not know it posed a risk in children. I guess that thought is naïve of me, since many supplements and drugs can potentially be unsafe in children and adolescence. Although, Echinacea might help adults with upper respiratory tract infections or the common cold it seems as if other options might be more suitable for use in children.

[ee]

Contrary to the popular belief that natural products are always safe since they are “natural”, all natural products are not always safe for everyone. Doing a little more research before consuming a natural product is always good. A lot of people look for natural ways to help with their symptoms of either cough or cold or even stomachache. I am glad they conduct such studies to further enrich the public’s knowledge on natural products and their safety based on different age groups and disease states.

[My Lien T. Nguyen]

As Carla commented: "Pediatrics + OTC and natural remedies = sticky spot"
Not only OTC or natural remedies, but all medicines, children are not just little people. Their liver and renal functions, absorption of drugs, water to fat composition, and more are different from adults (in which drug clinical trials are conducted) and thus process materials differently. The echinacea article underscores the need for more review of natural products use in children.

[DS]

I am very surprised to hear that Echinacea is not safe for children under 12. Since it is a plant, I thought it would be safe for most people. This just shows that we cannot assume that all herbal products are safe for everyone. I wonder why there is an increased allergy risk in children?

[ki]

I am glad that I read this article. As a pharmacist, I often have patients ask questions about using echinacea supplementation to boost the immune system during a cold. It is important to know about this potential risk. I do agree with Nicole, I think it would be interesting to see if the patients who had a reaction to echinacea had any other allergies. It is common to see patients with allergies to several different types of plants and this may provide insight into other types of allergies patients with an echinacea allergy should expect.

[weezy]

This is a perfect example of a natural/herbal product that can actually be harmful, but the safety aspect is probably often overlooked by consumers due to the fact that it is OTC and a herbal remedy. It is so important to know what is safe for children so I'm glad to know about this risk for children younger than 12. I would think this is probably a common go-to remedy for children so this is very useful information.

[anonymous]

My grandpa is a huge supporter of Echinacea. He takes it daily when he is sick or not and has been urging my parents to start taking it too. This is an interesting article though. I am glad that as children we didn’t take it. Whenever an a parents asks for a recommendation for a child at the pharmacy, I always feel nervous to recommend anything because there is little safety data for vitamins and drugs in children. That is good that they are going to relabel things that contain Echinacea to get the awareness out there!

[Maryjoy Lepak]

Following along with Nicole's comment, I would like to learn about the circumstances of the seven UK children who had an allergic reaction. She brought up an excellent point that we do not know whether these children were at a higher risk of an allergic reaction due to "plant allergies" or "co-existing asthma." It is also difficult to know whether or not the product came from a pure echinacea source. From the data presented, I am hesitant to make this a firm recommendation - but more of a precaution among high risk pediatric patients.

[anonymous]

This is a very serious issue. It is so important to be extremely careful with anything that is related to children. Not only is research often lacking in children, but it is important to remember children have different kinetics than adults. Allergic reactions can be very serious and life-threatening. I am thankful for this blog so that if I am asked about this Echinacea I can provide the most up to date information.

[ron]

Interesting read. Working in a retail pharmacy, I see a lot of people purchasing Echinacea, to help fight of their cold. This is definitely important information as a future healthcare provider, to let my patients know that Echinacea is not recommended in children younger than 12 now.

[Nicole]

I had read about this on a UK website and am glad they are updating their packaging labels. So many people in the US and EU use echinacea, especially in young children since many parents are interested in using "natural" and "drug free" products, so it is important that these new warnings are published. I had read that a total of 7 children in the UK have been reported to have this type of reaction following echinacea but I am curious to know if they had any other plant allergies that could have been cross-reactivity or possibly co-existing asthma that might have been responsible for these adverse reactions?

[AS]

I agree with this and it is great that products are being relabeled so consumers are aware of the risks. Using CAM products in children should always be done with caution since often there are limited studies on this specific patient population. According to NS the use of echinacea in both the treatment and prevention of upper respiratory tract infections in children has an evidence grade of C indicating that there is lacking or conflicting evidence.

[LO]

It's so important to look at the recommendations for products in our younger patients. Especially in natural or herbal products, medications commonly aren't studied in patients younger than 12 or 18 years old. We can't just assume a product is safe for everyone if it's natural. I'm glad that they are working to relabel the products!

[Marina]

According to the above article, the main reason Echinacea is not advised in children under 12 is for the risk of them developing an allergic reaction.

In the Natural Standard monograph for echinacea, the plants ragweed, chrysanthemum, marigold, daisy and chamomile are can produce an allergic cross-sensitivity.

So I am wondering, is echinacea not advisable for children as a blanket recommendation or for children with a history of allergic reaction to any of the above? Or might taking echinacea too early cause the children to develop an allergic reaction to this family of plants?

PS - I used to get propolis when I was younger!

[Carla]

Allergic reactions that the MHRA warns about are “rashes, hives, swelling including swelling of skin due to fluid and swelling of the face, difficulty breathing, asthma, and life threatening anaphylactic shock.” That sounds pretty similar to something found on a drug label. In the U.S., DSHEA prevents supplement labels from claiming that they treat a specific illness, but is there any law that says the label has to include side effects?

[Anonymous]

The combination of pediatrics and OTC and herbal medications are always a tricky issue to deal with. Many people call or walk in to the pharmacy and want a recommendation for their child who is having X and Y symptoms, and sometimes Z symptoms, but does not have insurance, or does not want to go to a doctor. This really puts you in a tricky spot. Many pharmacists aren't comfortable making recommendations to children for liability reasons and they know that the child should most likely see a doctor in case something serious is going on. Most OTC products will state something similar on the packaging as well. I can remember one time when I was working retail, a mother came up to the counter with a bottle of tums and asked if it was ok to give to her, who told her mother she was "just having heartburn". I asked how old her daughter was and she replied "11 years old". I then told her the manufacturer does not recommend giving to anyone under the age of 12 years old. The mom didn't like that answer very much. I recommended she see a medical provider because if that was the first time its happened, it may not even be heartburn. And if it was something that has been continuous and happened alot in the past, then still the daughter should see a medical provider to receive proper care.

Pediatrics + OTC and natural remedies = sticky spot

[anonymous]

I have never heard this claim before. Glad I read this article because Echinacea is a very popular supplement that customers buy in the pharmacy that I work at. Now I will have to be on the look out to warn the customers not to give it to their children or anyone under the age of 12 and warn them of the increased allergy risk. This is particularly practical because children seem to get sick more often and therefore may be more likely candidates to receive an Echinacea supplement. Also, some of the multivitamins that have claims to boost the immune system contain Echinacea.

[liz eh!]

Agreed but what about bee propolis instead when there is no allergy to bees or pollen?