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   Aug 19

Unlicensed Traditional Chinese and Ayurvedic Medicines found to contain heavy metals

All herbal safety warnings and alerts

19 August 2013

The MHRA has recently been made aware of several unlicensed  herbal products which have been found to contain heavy metals.

Product Names:
Bak Foong Pills
Hairegenerator
Niu-Huang Chieh-tu-pien
Divya Kaishore Guggul
Chandraprabha Vati

Product Description: 
The first warning relates to an unlicensed Traditional Herbal Medicine (TCM) Bak Foong Pills, containing lead, which is being prescribed by TCM practitioners for relieving menstrual discomfort.

Bak Foong Pills

The pills were recalled after samples were found to contain 1.8 and 2.3 times the limit permitted by the Hong Kong Government.

Bak Foong Pills are manufactured in Hong Kong by Hong Kong Medicine Manufactory.

The second warning relates to a TCM, Hairegenerator, containing excessive mercury, prescribed by TCM practitioners for the treatment of hair loss. Hairegenerator was recalled after a sample was found to contain 11 times the level of mercury permitted by the Hong Kong Government.

Hairegenerator

Hairegenerator is manufactured by Hang Cheong Lung Pharmaceutical Limited (HCL). Initial investigations by the Hong Kong Department of Health revealed that HCL supplied herbal ingredients to another licensed manufacturer, Luen Wing Chinese Medicine Manufacture Company Limited (Luen Wing), to manufacture Hairegenerator. Hairegenerator would then be returned to HCL for packaging before its distribution to the local market.

The Swedish National Food Agency (SNFA) reported that it had found “extremely high” levels of arsenic in products going by a variety of names including, Niu-Huang Chieh-tu-pien, and Indian names, Divya Kaishore Guggul and Chandraprabha Vati. The products are used to treat mumps, sore throat, tonsillitis, toothache, skin infections, anorexia and fever in infants.

Niu-Huang Chieh-tu-pien

All the above are unlicensed products and as such have not been authorised for sale in the UK. However, these and similar products are widely available on the internet and the public should exercise caution when purchasing unlicensed products as standards can vary widely and they have not been assessed by the MHRA for safety and quality puposes.

Possible side effects
The adulteration of ethnic medicines with heavy metals is a significant international problem. The Agency has received several reports of the use of, mercury, lead and arsenic in unlicensed Ayurvedic or traditional Chinese medicines. The inclusion of these metals, or salts containing them, pose a serious risk to public health.

Mercury – Inorganic mercuric salts can cause severe nausea, vomiting, abdominal pain, bloody diarrhoea, kidney damage and failure and potential nervous system effects.
Arsenic – can cause severe nausea, vomiting, skin disorders, haemorrhagic gastroenteritis, cardiac arrhythmias, anaemia, jaundice, peripheral neuropathy, convulsions and paralysis.
Lead – Can cause abdominal pain, vomiting, kidney damage, peripheral neuropathy, in coordination, impairment of mental function, convulsions and coma.

Reporting side effects
If you have taken any of these products and think you may be experiencing side-effects, please contact your doctor for advice. Take this information with you to help your doctor understand the situation. Please also help us gather more information on this issue by submitting a Yellow Card report.

Source: MHRA

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