Archive – Some Ayurvedic medicinal products reported to contain high levels of heavy metals

Starting date:

March 3, 2005

Posting date:

March 3, 2005

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Poisoning Hazard

Audience:

General Public

Identification number:

RA-11000331

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Consumers who use Ayurvedic medicinal products should be aware that a new study in the United States has found that some commercially produced products may contain high levels of lead, mercury and/or arsenic.

The December 2004 issue of the Journal of the American Medical Association (JAMA) reported a study of commercially available Ayurvedic medicinal products sold in the Boston area, which found that 14 of these products contained potentially harmful levels of lead, mercury and/or arsenic. Although none of these products has been authorized for sale in Canada, to date, three of these products are suspected to be available in various parts of Canada.

One product, SAFI, manufactured by Hamdard (Wakf) Laboratories in New Delhi/Ghaziabad, India was tested by Health Canada and found to contain arsenic levels in excess of 40 times the maximum allowable concentration for drugs. Described by its labelling as a blood purifier used for skin diseases and as a treatment for digestive problems, SAFI is available as a liquid in a 200mL bottle and packaged in a lime green box, bearing a black and red label on both the front and back. Consumers are advised not to use this SAFI product.

Heavy metals pose a particular health risk because they may accumulate in vital organs. Children are most susceptible to the toxic effects of heavy metal poisoning.

Arsenic poisoning can affect the liver, bone marrow, cardiovascular system and central nervous system, causing nausea, abdominal pain, vomiting, muscle cramps, heart abnormalities, liver damage, anaemia and reduced motor nerve function.

Lead poisoning can affect the kidneys, liver, heart and central nervous system, causing weight loss, insomnia, dizziness, swelling of the brain and paralysis. Mercury poisoning can affect the kidneys and central nervous system, causing tremors, insomnia, memory loss, slowed sensory and motor nerve function and reduced mental function.

Health Canada has reviewed the findings of the JAMA study and is currently determining the availability in Canada of the products named in the study. A Customs Alert to the Canada Border Services Agency has been issued to monitor importation of these products. Further action will be taken if any of the remaining products are confirmed to be sold in Canada, and if laboratory testing determines that heavy metal levels exceed Canadian exposure limits.

Ayurvedic medicinal products are used in the traditional Indian healing paradigm, and are often imported from India. According to the principles of Ayurvedic medicine, heavy metals are used in a detoxified state in these medicinal products because of their reputed therapeutic properties. However, should the detoxification process not be strictly followed during manufacturing, it is possible for the resulting product to contain high levels of heavy metals. In addition to the JAMA study, other studies have found high levels of heavy metals in products sold in England and India. In Canada, Ayurvedic medicinal products must be authorized for sale either as a natural health product bearing a Natural Product Number (NPN) or a drug product, bearing a Drug Identification Number (DIN). These eight digit numbers are preceded by NPN or DIN and indicate that the product has been assessed by Health Canada for safety and effectiveness.

The JAMA study reported high levels of heavy metals in the following 14 Ayurvedic products

High levels of heavy metals in 14 Ayurvedic products

Product Name	Manufacturer	Indication(s) on Label
Bal Chamcha	Jalaram	problems associated with liver, digestion, teething, milk intolerance, irregular stools, regurgitation, bloating, parasites, colic, poor sleep, poor dentiton*, and myalgias*
Bala Guti	Zandu	children's tonic
Bala Sogathi	Navjeevan	for healthy growth of children, teething, cough, cold, fever, diarrhoea etc
Balaguti Kesaria	Kesari Ayurvedic Pharmacy	tonic tablets for babies with sudha and gold rickets, coryza*, cough griping, skin roughness, worms and dentiton*
Gesari	Harinarayan Pharmacy	indigestion, stomach problems, peptic pains*, uneasiness, bloating
Karela	Himalaya	metabolism regulating
Maha Sudarshan Churna	Dabur	malaria, febrile conditions* varied etiology
Maha Sudarshan Churna	Zandu	diaphoretic*, anti-malarial dyspepsia*, loss apetite
Mahalakshmi Vilas Ras with Gold	Baidyanath	weak lungs, cold, nasal problems, cough, runny nose, respiratory problems, blood deficiency, sinus HA, wound healing, asthma, palpitation, flu
Mahayograj Guggulu w/silver & Makardhwaj	Baidyanath	rheumatic pain, bile, pigmentation disorders, blood purific, eye problems, weakness
Navratna Rasa	Unjha Ayurvedic Pharmacy	general debility, rickets, calcium deficiency
Safi	Hamdard Pakistan	digestive systems, constipation, dermatitis
Shilajit	Syncom	tonic, bronchial skin piles, anaemia, inflammation, excess fat, dyspepsia*, worms, constipation
Swarna Mahayograj Guggulu with Gold	Baidyanath	pain, gas, rheumatism, CVA*, menstrual cycles, progesterone deficiency, strengthening arteries/veins, weak vital organs, mental disorders, fertility, menopause

* Dentition (dental problems); myalgias (muscle pain); coryza (runny eyes and/or nose); febrile conditions (fever); diaphoretic (perspiration); dyspesia (stomach pain); and CVA (cerebrovascular accident).

Consumers who have used any of these products and who are concerned about their health should contact a health care professional for advice. For more information about lead, mercury or arsenic poisoning, contact the nearest poison control centre.

The public is encouraged to inform Health Canada if they see these products for sale, or if they have any questions about this advisory by contacting the Health Products and Food Branch Inspectorate toll free number (1-800-267-9675). Should future laboratory tests find other products with high levels of heavy metals, this advisory will be updated.

To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario
K1A 0K9

Email: cadrmp@hc-sc.gc.ca

Or visit our website:
MedEffect™ Canada

Health professionals and consumers may report adverse reactions toll free to Health Canada at:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

Your call will be directed to the appropriate Regional Centre.

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