Public advisory

Archive – Health Canada Warns Consumers Not to Use Certain Ayurvedic Medicinal Products

Starting date:
July 14, 2005
Posting date:
July 14, 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-11000686

Health Canada is warning consumers not to use certain Ayurvedic medicinal products because they contain high levels of heavy metals such as lead, mercury and/or arsenic. Health Canada is taking action to remove these products from the market and to prevent further importation into Canada.

Ayurvedic medicinal products are used in traditional Indian healing and are often imported from India. According to the principles of Ayurvedic medicine, heavy metals may be used because of their reputed therapeutic properties. However, improper manufacturing processes may result in dangerously high levels of heavy metals remaining in the final 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. For example, arsenic poisoning can cause nausea, abdominal pain, vomiting, muscle cramps, heart abnormalities, liver damage, anaemia and reduced motor nerve function. Lead poisoning can cause weight loss, insomnia, dizziness, swelling of the brain and paralysis. Mercury poisoning can cause tremors, insomnia, memory loss, slowed sensory and motor nerve function, and reduced mental function.

The following is a list of the unapproved Ayurvedic medicinal products found on the Canadian market thus far, which have been analyzed by Health Canada and found to contain high levels of lead, mercury and/or arsenic:

  • Karela tablets, produced by Shriji Herbal Products, India
    Karela capsules, produced by Himalaya Drug Co, India
  • Karela capsules, produced by Charantia, UK (specifically batch #12011)
  • Maha Sudarshan Churna powder, produced by Zandu Pharmaceuticals, Mumbai, India
  • Maha Sudarshan Churna powder, D & K Pharmacy, Bhavnagar, India
  • Maha Sudarshan Churna powder, produced by Chhatrisha, Lalpur, India
  • Maha Sudarshan Churna powder, produced by Dabur India Ltd, New Delhi, India
  • SAFI liquid, produced by Hamdard-WAKF-Pakistan
  • SAFI liquid, produced by Hamdard-WAKF-India
  • Yograj Guggul tablets, produced by Zandu Pharmaceuticals, Mumbai, India
  • Sudarshan tablets, produced by Zandu Pharmaceuticals, Mumbai, India
  • Shilajit capsules, produced by Dabur India Ltd, New Delhi, India

As a precaution, Health Canada advises Canadians not to use any other Karela, Safi, Maha Sudarshan Churna, Yograj Guggul, Sudarshan or Shilajit products unless they have the required market authorization.

Health Canada will be working with the importers and distributors of these products to remove them from the market.

Canadians should only use Ayurvedic medicinal products that have been authorized for sale by Health Canada. Authorized natural health products will either bear an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM). This authorization indicates that the product has been assessed by Health Canada for safety, efficacy and quality.

Consumers who have used any of these products and who are concerned about their health should contact a health care professional for advice. Consumers with this product are advised not to dispose of the product until they have contacted their Municipal Government regarding the safe disposal of these products. For more information about lead, mercury or arsenic poisoning, contact the nearest poison control centre.

This warning follows a Health Canada advisory issued March 3, 2005 after Health Canada reviewed a study in the Journal of the American Medical Association (JAMA) that found potentially harmful levels of lead, mercury and/or arsenic in 14 commercially available Ayurvedic medicinal products sold in the Boston area.

The public is encouraged to inform Health Canada if they see any of the above listed Ayurvedic medicinal 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).

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

Your call will be directed to the appropriate Regional Centre.

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