Is banning a fitting remedy?

MEDICAL HERBALISTS are up in arms about the recent Irish Medicines Board (IMB) ban on the use of popular herbal remedy, echinacea, for children under 12.

At the end of August, the IMB said the children’s herbal products containing echinacea were no longer recommended because of the lack of scientific data to support their use.

Pharmacies and health stores were thus required to remove echinacea-containing products for children from shelves and manufacturers were required to remove information on children’s dosage from adult echinacea products.

IMB director of human products authorisation Ann O’Connor said the decision was taken following a review of information on the safety and efficacy of echinacea products and guidance from the European Medicines Agency (EMA). The IMB concluded that the use of echinacea can be associated with rare side effects, mainly allergic reactions, which in some cases may be severe.

“Our view is that there are potential risks associated with the use of echinacea-containing products in children under 12 and there is limited benefit in this age group,” she said. “This is not a serious safety issue and the measures being taken are precautionary in nature. Parents should have no concerns if they have given echinacea to children under 12 in the past.”

Medical herbalists question this decision on several counts. First, they believe the review is based on studies which are “flawed” and that the rare side effects refer to a very small number of cases.

“The IMB’s decision is based on three adverse events [reactions] in children reported to the IMB and other adverse events reported to the World Health Organisation and the European Medicines Agency which information is not publicly available for. I think the IMB’s decision to ban echinacea for children under 12 is linked to a concern that it might interfere with the development of children’s immune system,” says Anne Varley, medical herbalist and chairwoman of the Irish Medical Herbalists Organisation (IMHO).

The IMHO is seeking access to all the data on adverse effects that the IMB’s decision was based on. The organisation is already aware of a number of published studies on echinacea and children – one of which showed there was no change in symptoms and some allergic reaction when echinacea was taken.

However, Varley argues that this study used the harvested flowers of echinacea “which have a high pollen count which could have caused the allergic reaction” and the treatment was started only when two cold symptoms were identified.

According to Varley, other research studies have found that adults show huge improvement if they are given echinacea immediately after the first symptom of a cold appears – in a high dose every couple of hours. “One particular study found a 23 per cent reduction in the severity and duration of cold symptoms when this protocol was followed,” she said.

Vivienne Campbell is a well-known medical herbalist based in Co Clare.

“I give echinacea to babies and I’m not a risk taker,” says Campbell. “It was the first herb I ever took myself. Really, what should have happened was that echinacea products could carry a label saying this product is not suitable for children who have allergies.”

Galway-based medical herbalist and GP, Dr Dilis Clare, says she hasn’t encountered any problems giving echinacea to children since she set up her practice 12 years ago. “The problem with the research into echinacea is that the sample sizes are too small to prove a gentle effect. Banning echinacea for children means that we, as medical herbalists, will waste valuable consultation time reassuring patients about echinacea. The IMB has caused a national scare about a herb which we would all give to our children and grandchildren.

“Echinacea is a member of the daisy family and some people are sensitive to this family of plants,” adds Campbell.

“Usually the reactions are very mild – a slight rash on the hands from handling the daisy plants or a couple of mouth ulcers if taking the plants internally. Also, we’d be cautious with anyone who has a medical history of allergies.”

Medical herbalists will of course still be able to prescribe echinacea to children (as opposed to being available over the counter). “For our patients, we make up individualised blends and we will continue to prescribe echinacea according to our clinical judgment which would include any possible allergic reaction,” says Clare.

The Irish Association of Health Stores (IAHS) also criticised the ruling from the IMB. A spokesperson for the IAHS says products containing echinacea had been used by children in Ireland for almost 20 years over which time there was “no knowledge of any adverse event”.

Health stores are actively encouraged to report any comments from customers on side effects of products purchased in their stores. In fact, even members of the public can report an adverse effect of medication – herbal or pharmaceutical – to the IMB.

Manufacturers of echinacea products are now legally obliged to change the dosage instructions on their products. “Although we disagree with the IMB’s position, we have no choice but to comply,” says Dr Jen Tan, medical director of Bioforce (A Vogel).

“Bioforce operates a herb safety monitoring system and records complaints from consumers and healthcare professionals. Since 2003, we haven’t received any reports of children under 12 experiencing allergic reactions to echinacea. There have been two cases of children taking accidental overdoses of echinacea junior [now banned], both of which resulted in no symptoms developing.”

Ultimately, according to medical herbalists, the ban on using echinacea in children will push the use of it “underground”. “People are telling us that they will buy it for themselves and give it to their children, which is more dangerous,” says Clare.