Article date: April 2008
Most herbal medicines on the UK market are currently unlicensed products. Standards vary widely, and it is difficult for consumers or healthcare professionals to identify which products are manufactured to acceptable standards with reliable product information. The Herbal Medicines Advisory Committee was set up 2 years ago to advise the MHRA about safety issues related to herbal medicines.
The MHRA has previously issued warnings about herbal products that contain the toxic ingredient Aristolochicia species, heavy metals, or potent pharmaceutical substances (eg, fenfluramine).
Safety case studies:
- Recently, we warned consumers about a herbal body lotion (OSAS) that claimed to contain natural ingredients, but tested positive for betamethasone. The product was brought to our attention by a paediatric dermatologist who was concerned that a parent of a baby he was treating for eczema had started using the product on the infant
- Reports of suspected adverse drug reactions were linked to an unlicensed herbal product that was marketed for diabetes, which gave dangerous advice to patients to stop taking prescribed medication
For further examples of previous safety warnings about herbal medicines that contain potent or toxic ingredients see Herbal Safety News: Current safety issues
New regulation to safeguard public health
Regulation safeguards will be improved by the recent introduction of the Traditional Herbal Registration (THR) scheme. The first products registered in the UK under this scheme are now coming onto the market. As at March 2008, 11 products have been registered covering a total of ten different herbs. Registered products have been assessed by the MHRA and meet systematic standards of safety, quality, and patient information. Registered products are suitable for use without medical supervision, and indications are based on traditional use rather than proven efficacy. Herbal medicines with a Marketing Authorisation also continue to be available.
The Herbal Medicines Advisory Committee believes it is important to use the growing availability of regulated products and reliable information to enhance patient safety. Healthcare professionals will be increasingly better placed to advise patients who wish to self-medicate with over-the-counter herbal products on how they can make an informed choice in appropriate situations.
How to identify regulated herbal products:
- Herbal medicines with a Traditional Herbal Registration have a THR number on the product label
- Herbal medicines with a Marketing Authorisation have a PL number on the product label
The image below shows part of the label, including THR, for Niteherb (valerian, for temporary relief of sleep disturbances due to symptoms of mild anxiety):
The image below shows an extract from the leaflet for Prostasan (saw palmetto, for relief of symptoms of an enlarged prostate), which has a THR:
Sources of information about herbal medicines on the MHRA’s website:
- Public assessment reports for herbal medicines:
Covers products with a THR, and contains full information on registered products (including the Summary of Product Characteristics)
- Herbal information sheets:
Aimed at consumers; gives non-product-specific information about safe use of individual herbs; a reference collection of these sheets will progressively be prepared, making use of the MHRA’s assessment of THR applications
- Advice to consumers—safe use of herbal medicines:
Gives general advice, including avoidance of low-grade unlicensed products
Article citation: Drug Safety Update April 2008; Vol 1, Issue 9: 7