The Partnership for Safe Medicines
SafeMeds Alert
MHRA Notice
April 7, 2009
MHRA Warns Serious Health Risk Posed by Traditional Chinese Medicine "Herbal Viagra"  
Dangerously high levels of undeclared pharmaceuticals have been discovered in a supposed 'Herbal Viagra' being sold in many Traditional Chinese Medicine (TCM) stores in the United Kingdom. 

The product 'Jia Yi Jian' was recently seized by the Medicines and Healthcare products Regulatory Agency (MHRA) and claimed to contain only herbal ingredients.

However, laboratory analysis revealed the unlicensed product contained up to four times the level of pharmaceuticals found in legally prescribed medicinal products licensed for the treatment of obesity and erectile dysfunction.

Manufactured by Hu Nan Aimin Pharmaceuticals Ltd, the undeclared ingredients could cause serious side effects including significant heart and blood pressure problems as well as adversely reacting with other prescription drugs such as those for blood pressure, heart disease and some antidepressants.

Richard Woodfield, MHRA Group Manager for Herbal Medicines, said people should consult their GP or a health care professional before taking herbal medication particularly for serious medical conditions such as obesity or erectile dysfunction.

"This product, adulterated with large and uncontrolled amounts of pharmaceutical substances, presents a clear risk to consumers.

"There is continuing evidence that some so-called 'herbal' products on the UK and international markets are nothing of the kind.

"Often, such marketing claims about the supposed natural ingredients in these unlicensed products are simply an attempt to divert the consumer's attention away from very low manufacturing and ethical standards.

"The MHRA has issued warnings previously about adulterated products supplied by some TCM outlets, but the problem is by no means limited to that sector.

"The safest method to obtain medication is to see a health care professional and have a proper diagnosis, especially as sometimes conditions such as erectile dysfunction can be the symptom of something more serious."

The MHRA advise anyone using this product to stop taking it immediately and consult their GP or a healthcare professional.
The Jia Yi Jian product tested contained 68.1mg of Sibutramine and 50.06mg of Tadalafil.

Tadalafil is a prescription only ingredient for the treatment of erectile dysfunction but is only legitimately used to a maximum dosage of 20mg per tablet.

Sibutramine is a prescription only ingredient for the treatment of obesity and is only legitimately used to a maximum dosage of 15mg per tablet.

When healthcare professionals in the UK prescribe these medications, they do so in controlled circumstances having assessed their use as the most suitable treatment for the patient's condition. This importantly involves an explanation of potential side-effects as well as important ongoing monitoring of the treatment.

Information on previous safety concerns associated with herbal products can be found on Herbal Safety News pages of the MHRA website.

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone -the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.



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