Press release
| Date: | 11 February 2011 |
|---|---|
| Time: | 16:30 |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to warn people about the herbal weight loss product ‘Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula’ after test results have now revealed it contained more than twice the prescribed dose of a banned powerful pharmaceutical ingredient, sibutramine.
Sibutramine was a Prescription Only Medicine (POM), however, its marketing authorisation (product licence) was withdrawn for safety reasons in January 2010 following a warning from the European Medicines Agency that it increased the risk of heart attacks and strokes.
Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula is believed to be widely available over the internet as well as in some Traditional Chinese Medicine (TCM) outlets in the UK.
Anyone currently using this product should stop taking it and consult their healthcare professional immediately.
This issue was bought to the Agency’s attention by a concerned GP after one patient was hospitalised and several others reported suffering a range of side effects including palpitations, severe gastritis and abdominal pain, as well as insomnia after taking the capsules.
MHRA Head of Herbal Medicine Policy, Richard Woodfield, said: “Since 2005, the MHRA has found over 280 examples where so-called ‘herbal’ or ‘natural’ products have been adulterated with random quantities of powerful pharmaceutical substances. Such products pose a real risk to the public.
“It is situations such as this one that the Traditional Herbal Registration (THR) scheme is being introduced and why EU legislation has been changed in order to regulate herbal medicines.
“People have a right to know that what they are putting into their bodies to treat one condition will not directly cause a possibly more severe one simply as a result of very poor practice in parts of the sector.
“The THR scheme will make it possible to give people clear advice on which herbal products are safe to use, and provide an assurance that they were made in adequate conditions, and to the necessary standard.”
Notes to Editor
- For pictures of Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula, contact the MHRA press office on 020 3080 7651 or press.office@mhra.gsi.gov.uk
- Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula is developed by Bitter Orangs Trade CO. Ltd and Chinese Scientific Academy.
- 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 judgements 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.
- Further information on the MHRA’s THR scheme and details of products granted a THR can be found on the Traditional Herbal Medicines Registration Scheme page of the website.
- Additional information on the most recent alerts can be found via the following links
5 Nov 2010: Warning about 'herbal slimming pills' containing banned Prescription Only Medicine sibutramine
6 Oct 2010: Herbal product alert: Payouji (or Paiyouji) tea and Pai You Guo (Slim Capsules)
16 Sep 2010: Warnings received from overseas medicines agencies
Press release: Update: People warned over adulterated herbal weight loss pill – test results reveal twice the prescribed dose of banned pharmaceutical ingredient 
