MHRA message – Herbal and homeopathic medicines: reminder to be vigilant for suspected adverse reactions and to report them to the Yellow Card scheme
9 Jul 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a reminder of the need to be vigilant for suspected adverse reactions to herbal and homeopathic medicines and to report them to the Yellow Card Scheme.
As you will be aware, herbal and homeopathic medicines are available from a wide range of outlets such as pharmacies, retail stores, online shops or supplied by herbal or homeopathic practitioners and only some of these are licensed by the MHRA.
The MHRA monitors both licensed and unlicensed herbal and homeopathic medicines in order to protect patient safety.
The MHRA Yellow Card reporting scheme has identified many important safety issues for herbal medicines, for example, interactions between St John’s wort and hormonal contraceptives and anti-epileptic medicines, which were unknown before being reported.
In addition, our vigilance of herbal products has led to warnings regarding the use of Butterbur (Petasites hybridus) products. Butterbur contains pyrrolizidine alkaloids, which can cause serious adverse effects such as liver damage and organ failure. The MHRA has previously published a safety alert advising consumers not to take unlicensed Butterbur herbal remedies. This advice remains unchanged.
Although homeopathic medicines are sometimes diluted to contain only a few molecules of active ingredient, a recent study highlighted a manufacturing error for a homeopathic medicine that resulted in an accidental atropine overdose and hospitalisation in a patient in Germany. Although this occurred outside of the UK, it is an example of the need to consider these medicines in patients who have an adverse reaction.
We are asking healthcare professionals to follow the Advice for healthcare professionals and the Advice for healthcare professionals to provide to patients’ sections in the Drug Safety Update article. We also ask healthcare professionals to establish with their patients if they are taking herbal or homeopathic medicines and to remind patients that if they are taking these medicines, they need to check that they are using licensed products.
Please see the article for information on how to identify whether a herbal or homeopathic medicine is licensed in the UK.
MHRA safety warning – Herbal products containing Butterbur
2 Jul 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware of a magazine article which promotes the use of Butterbur (Petasites hybridus) for the treatment of hayfever, or to treat migraines, asthma, chronic coughs and gastric ulcers. We advise patients not to take herbal products containing Butterbur to treat these conditions.
These are unlicensed herbal medicines that present a serious risk to public health, as they can cause liver toxicity, organ failure and other dangerous side-effects.
In January 2012, the MHRA published a safety alert advising people not to take unlicensed Butterbur herbal products, following reports of Butterbur products being associated with cases of liver toxicity and our advice remains unchanged.
There is no guarantee that unlicensed herbal medicines meet quality, safety, efficacy, and patient information standards required in the UK. This can endanger the health and welfare of people who take them.
Patients taking herbal products containing Butterbur should be advised to stop using them immediately and seek advice from their GP or pharmacist if they have any concerns.
Anyone can report any suspected side effects of herbal medicines via the Yellow Card scheme.
If you have any queries, please email MHRACustomerServices@mhra.gov.uk.
The BHMA AGM & WEBINAR
Thursday 17 June 2021, 11.45am
The Provision of THR Medicines and Northern Ireland
In the last few weeks the BHMA has been asked a number of questions on the provision of THR medicines to Northern Ireland after the Brexit transition period ends on 31st December. The MHRA has confirmed that THR products marketed in Northern Ireland will need to continue to comply with the current EU regulatory requirements. For advice on licensing procedures in general, importing/exporting, pharmacovigilance etc., please contact the MHRA Customer Services Centre firstname.lastname@example.org directly. The reason for this is the MHRA is working to collate all such enquiries received and they will also be able to quickly direct enquiries to the appropriate team. The MHRA GDP Inspectorate has also advised: “In relation to time lines please note that the Ireland/Northern Ireland Specialised Committee issued a press release that included: The UK and the EU exchanged updates on the implementation of the Protocol. The Committee noted that an agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements. https://www.gov.uk/government/news/irelandnorthern-ireland-specialised-committee-05-november-2020 Further guidance will be issued in due course.” Published: December 2020
Transition Guidance – Useful Links
Here are some useful links to the end of transition guidance from the Medicines & Healthcare products Regulatory Agency (MHRA):
- MHRA post-transition period information
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
- Contact list – Enquiries about the period from 1 January 2021
Published: December 2020
Known Herb / Drug Interactions are Easily Checked
Responding to national newspaper reports on herb / drug interactions this week, Chris Etheridge, Chair of the British Herbal Medicine Association says: “Whilst it is well known that in a few well documented cases, herbal medicines can affect the way prescribed and over-the-counter medicines work – such as St John’s Wort – the majority of herbal medicines are not known to affect prescription medicines in this way. “Anyone that is considering taking a herbal medicine should always buy one that displays the THR logo on the pack. It is important that you read the THR in-pack leaflet before taking the herbal medicine in order to ensure that it is safe and appropriate to do so. If you are taking another medicine, either prescribed by your doctor or over-the-counter, it is also sensible to double check its leaflet to ensure that it is safe to take the medicines and herbal medicine together. The information contained in these leaflets is accurate and reliable, and has been approved independently by the UK medicines licensing authority, the Medicines and Healthcare Products Regulatory Agency.” For more information on how to check if your herbal medicine can be taken with your prescribed medicine, click here. Published: Sept 2018
New BHMA Chair Appointed
Having worked tirelessly for the BHMA in recent years, we are both sad to announce the standing down of our current Chairman, Dr Dick Middleton, and pleased to announce that Dr Chris Etheridge has been appointed as our new Chair of the BHMA effective from 1 January 2018. Although Dick Middleton is retiring from his day job and standing down as BHMA Chairman, he will continue to contribute to our Association, working closely with other board members to ensure progression of the regulation of herbal medicines that are available to the public in the UK, either OTC or through herbal practitioners. Speaking of his appointment, Chris Etheridge says: “I feel deeply honoured to be taking on the role of Chair of the BHMA from Dick Middleton. I look forward to continuing his excellent work in promoting the THR scheme, and further developing the supportive seminars and workshops for THR holders. In addition, the BHMA will also look at creating a new online resource for all health professionals, where they can access information about THR products. The BHMA’s Herbal Practitioner Suppliers Scheme (HPSS) will continue to build a standard level of GMP across the whole practitioner supplier sector, improving any quality issues that may exist. “I look forward to facing the challenges of being the BHMA chair. This is a critical time for herbal medicine and I believe the BHMA is in a strong and unique position to be a leading authority in defining the continued future of herbal medicine in the UK and beyond.” The BHMA extends its thanks to Dick Middleton for all his hard work and dedication as BHMA chair for the last few years. We all owe him a large debt of gratitude.
Government Refusal to Regulate UK Herbal Practitioners as ‘Ideological Madness’
The BHMA endorses the views held by the European Herbal and Traditional Practitioners Association (EHTPA) and detailed in their recent press release that Government inaction on statutory regulation of herbal practitioners is a significant risk to public health.
The Walker Report recommendations earlier this year, authored independently by Professor Walker, whilst including detailed minutes of the Government Working Group meetings, unsurprisingly failed to include the damning Safety Report by the Herbal Medicines Advisory Committee (HMAC). This report, commissioned by Professor Walker, has now, commendably, been placed in the public domain by the EHTPA, and makes depressing and stark reading in terms of the ongoing safety to public health. If the expected Government endorsement of Professor Walker’s recommendations goes ahead later this month, it is difficult to see how this can be anything other than an ongoing significant risk to public health, given the facts laid out in the HMAC Safety Report. Dr Dick Middleton, Chairman of the BHMA says: “The BHMA is particularly concerned at the quality of supply of herbal materials dispensed by unregulated herbal practitioners. The HMAC Safety Report is littered with examples of poor, unsafe and unregulated practice which has risked, and continues to risk, the health of patients. “The Government’s policy on reducing bureaucratic regulation is clear, and where appropriate, is commendable. However, on this occasion, the BHMA believes that continuing lack of regulation of herbal practitioners will continue to damage public health to a significant extent. Furthermore, this risk will only increase as growing patient numbers, disenfranchised with an over-burdened National Health Service, turn to alternative treatments that lack substantial governance or regulation.”
National News – Tuesday 14th July 2015
The Daily Mail and BBC Online News have printed information about the findings of the next BBC programme Trust Me I’m a Doctor, due to be aired on Wednesday 15th July. The findings illustrate the importance for consumers to choose traditional herbal medicines when purchasing herbal products. Herbal medicines regulated under EU medicines law are suitable for treating self-limiting minor ailments. These herbal medicines display a THR logo on the carton and they always include an in-pack leaflet which gives reliable, approved customer information. All of these herbal medicinal products are of consistently high quality and can be purchased by consumers with confidence. Herbal products that do not include a THR logo on the pack are not regulated as medicines and may, in a number of cases, not be manufactured to such high standards. The BHMA website www.bhma.info gives detailed information about traditional herbal medicines that are available to purchase in the UK, both on-line and in retail outlets. To find THR traditional herbal medicines for a range of indications such as coughs and colds, or stress and anxiety, click here: https://bhma.info/indications/
BHMA Members shared memories, laughter and thought provoking opinions as they celebrated the BHMA 50th Anniversary at the Barber Surgeon’s Hall, 11 June 2015.
The AGM commenced mid-morning with forty members present to review the BHMA’s year and financial accounts, after which a further 50 members joined the event and enjoyed an outstanding herb themed lunch in the convivial surroundings of The Great Hall. “The 50th Anniversary Celebration Lunch was an inspiring occasion,” said current Chairman, Dr Dick Middleton. “The opportunity to reminisce over past challenges and achievements was made all the more easy with a splendid display of memorabilia, put together by Board Member Peter Bradley. This was complemented further perfectly by an inspiring speech from Victor Perfitt, a past-Chairman of the BHMA, who gave an often amusing snapshot into the characters and personalities who have shaped the Association over the last 50 years.” Dr Middleton rounded off the proceedings with a speech in which he reminded the audience of the enormous improvements that current European regulations have made to public safety in relation to OTC herbal medicines. He congratulated the many companies involved in manufacturing and marketing THR herbal medicines as well as the MHRA regulators, in improving public safety and ensuring a wide availability of high quality medicinal herbs such as St John’s Wort, Black Cohosh and Echinacea. Dr Middleton reminded the audience that low quality botanicals are still appearing on the UK market, particularly through websites, with alarming regularity and that the BHMA in the future would work closely with both UK and International trade associations, professional herbal practitioner associations, regulators, academic experts and the media to educate companies and improve the quality of global supply chains. Special thanks go also to The Beadle of the Barber Surgeons’ Hall for making the BHMA most welcome, to Vicky the archivist for opening up the library to share the 16th and 17th Century editions of John Gerard’s ‘Herball’ and finally, to Dr Timothy Cutler for his informative and entertaining speech on the history of the herb garden at the Hall.
27 March 2015: Government U-turn leaves public safety at risk from rogue herbalists
The EHPTA and the BHMA has issued a joint press release in response to Professor David Walker’s ‘Report on the Regulation of Herbal Medicines’ published late on Thursday 26 March 2015. Despite previous agreement that statutory regulation could be the only way to safeguard the public from poorly trained and unethical herbal practitioners, in the report Professor Walker recommends voluntary accreditation by the Professional Standards Authority (PSA). In objection to the recommendation for voluntary accreditation, an open letter to the Department of Health has subsequently been supported and signed by over half of the Herbal Practitioner and Medicines Working Group objecting to the report and calls on the government to reconsider its decision in the interest of public health. Click here for a copy of the full letter. Dr Dick Middleton, Chair of the BHMA said, “The BHMA fundamentally disagrees with the recommendations made by Professor Walker which he has made to the Government under the guise of the Herbal Medicine Practitioners Working Group. We are particularly concerned that at a time when the quality and provenance of herbal food supplements is being questioned in the US and Europe, that there should be a recommendation to consider the supply of herbs supplied by herbal practitioners as herbal food supplements. This will increase the risk to public safety.”