2005-09 March 3, 2005 For immediate release Advisory OTTAWA -- 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)1 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: 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: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_e.html Health professionals and consumers may report adverse reactions toll free to Health Canada at: Tel: 866 234-2345 Fax: 866 678-6789 Your call will be directed to the appropriate Regional Centre. -30- Media Inquiries: Nathalie Lalonde Health Canada (613) 957-1803 Public Inquiries: (613) 957-2991 Saper RB. Kales SN, Paquin J. Burns MJ, Eisenberg DM, Davis RB, Phillips RS. Heavy metal content of ayurvedic herbal medicine products JAMA, 2004 December 15; 292 (23):2868-73.
