Unlicensed herbal remedies for erectile dysfunction, available over the internet, could present serious health risks according to recent test results received by the MHRA.

The MHRA received advice from the Federal Agency for Medicines and Health Products in Belgium as well as the Food and Drug Administration (FDA) in the USA on 'Africa Black Ant', 'Rock Hard Weekend', 'Pandora' and 'The Best'.

These unlicensed products were found to contain the Prescription Only Medicine (POM) sildenafil, which should only be used when prescribed by a doctor and could cause potentially life-threatening high blood pressure.

The products have been marketed over the internet as a 'herbal supplement'. However, consumption of sildenafil in unknown or uncontrolled quantities could be extremely dangerous and cause serious adverse reactions such as heart attacks and strokes.

MHRA Head of Herbal Policy Richard Woodfield said: "Historically, with unlicensed herbal medicines, people have needed to be aware that the standards could vary widely and sometimes be poor.

"However, an increasing range of herbal medicines made to assured standards are now available on the UK market thanks to the Traditional Herbal Registration (THR) scheme."

Registered and licensed herbal medicines can be identified by the THR logo or the product licence (PL) number on the label.

The scheme has been designed so that the public will no longer have to guess at the safety and quality of herbal medicines.

Mr Woodfield added: "In the UK, certain medicines are categorised as POM due to their potent nature, so they should only be used under the care and supervision of suitably qualified healthcare professionals. "The unlawful sale of products posing as 'herbal' but containing POMs is a serious threat to public health and could be dangerous. Anyone with information about the sale or supply of products such as these should notify us immediately."

Any side effects of herbal products can be reported to the MHRA via the Yellow Card Scheme.

Notes

1. 'Africa Black Ant' comes in red and black packaging and is promoted as a natural dietary supplement or herbal Viagra for erectile dysfunction.

2. 'Rock Hard Weekend' and 'Pandora' capsules come in blister packs and bottles and are marketed as sexual enhancers for men and women.

3. 'The Best' is a male sexual enhancer and comes in yellow and red packaging with single blister capsules. It is promoted as a herbal Viagra for erectile dysfunction.

4. Members of the public are advised that they should only take Prescription Only Medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

5. The Traditional Herbal Registration (THR) certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the MHRA under the THR scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC (external link). Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.

Source:
MHRA