OTTAWA - Health Canada is warning consumers not to use the natural health product Trophic Kelp & Glutamic Acid HCl due to the health risk posed by exposure to high levels of iodine. Women who are pregnant or breastfeeding, and individuals with thyroid disease such as Graves' disease are particularly at risk.Excessive iodine exposure can result in an enlarged thyroid and may cause either hypothyroidism (underactive thyroid disease) or hyperthyroidism (overactive thyroid disease) in susceptible individuals. Symptoms of hypothyroidism include weight gain, joint or muscle pain, fatigue, weakness, depression, increased sensitivity to cold, and abnormal menstrual cycles. Over time, untreated hypothyroidism may lead to infertility and heart disease. Hyperthyroidism symptoms include sudden weight loss, rapid or irregular heartbeat, increased sensitivity to heat, sweating, nervousness or irritability. Stroke is one of the most serious complications of hyperthyroidism. Unborn babies are very sensitive to high levels of iodine and may be born with an enlarged thyroid. Significant swelling of the thyroid could compress the baby's windpipe and interfere with breathing. As well, high levels of iodine in individuals with thyroid disease such as Graves' disease may reduce the effectiveness of antithyroid medications.
Health Canada cautions consumers, especially women who are pregnant or breastfeeding, individuals with thyroid disease such as Graves' disease or individuals with previous iodine deficiencies, to be aware that kelp products contain iodine, and advises them to consult their health care practitioners prior to taking these products.
Trophic Kelp & Glutamic Acid HCl provides an excess amount of iodine. Although not approved for sale in Canada, the product was available at retailers and pharmacies across Canada, and over the Internet. Trophic Canada Ltd. has initiated a recall of the product. Health Canada will monitor the effectiveness of this recall. Consumers are reminded that drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.
Health Canada advises retailers to remove Trophic Kelp & Glutamic Acid HCl from their shelves, and consumers should return the product to the place of purchase. Consumers who have taken the product and have health concerns should consult with a health care professional.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
No comments:
Post a Comment