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.

Herbal medicines

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.

Homeopathic medicines

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.

Healthcare professionals and patients are advised to report any suspected adverse reactions via the MHRA Yellow Card scheme