The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning against a Traditional Chinese Medicine (TCM) after adverse reactions indicated it contained an unauthorised, unspecified pharma ingredient.
The product, ‘Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula’, was recalled after a doctor reported the hospitalisation of a patient who had taken the product.
Separate adverse events included palpitations, gastritis, abdominal pain and insomnia.
While not releasing the name of the contaminant, previous MHRA warnings for similar products referenced sibutramine. The MHRA said lab testing of the product was underway.
In issuing the warning, the MHRA warned anyone taking the product to cease and consult a doctor. It also took the opportunity to promote the Traditional Herbal Medicinal Products Directive (THMPD), as a regulation that had been enacted to deal with such transgressions.
“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,” said MHRA head of herbal medicine policy, Richard Woodfield.
“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.”
The THMPD requires all herbal products making health and medicinal claims to gain THRs but response has been lacklustre across the EU so far. The regulation came into force in 2004 and manufacturers were given a seven-year grace period to comply, which expires in April 30 this year.
The UK has seen the most activity where, as of December 31, 2010, there had been 187 registrations for individual products. Eighty four products had been approved and none rejected. But many member states have seen no registrations at all meaning 1000s of products may be about to have their legal status changed.