Following a report of a UK case of liver failure suspected to be associated with an unlicensed traditional Chinese medicine (TCM), the MHRA has discovered the illegal and dangerous inclusion of nitrosofenfluramine and fenfluramine, in Shubao Slimming Capsules being supplied on the UK market.
Fenfluramine is an appetite suppressant which was banned globally on health grounds in 1997 due to concerns about the drug’s effect on the heart.
Nitrosofenfluramine is known to be toxic to the liver. Globally, the illegal adulteration of slimming products with nitrosofenfluramine and fenfluramine has been associated with a large number of reports of liver toxicity.
In Japan 160 people are known to have been made ill, and four patients have died following the use of several TCM slimming products thought to contain these drugs.
The UK patient required and received a liver transplant.
The Agency is investigating the matter and has seized samples of Shubao from a number of TCM outlets in the UK. All of the samples tested contained nitrosofenfluramine and/or fenfluramine. The amount of the substance(s) varied widely making assessment of the health risk problematic.