Foreign Product Alert
2012-13
January 25, 2012
For immediate release
Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info




| Product | Undeclared Ingredient |
|---|---|
| Cardiotium | losartan atorvastatin |
| Paidusu | sibutramine, phenolphthalein thyroxine |
| SlimEasy Herbs Capsule | sibutramine phenolphthalein |
| Tianran Zuanshi Xianweisu | sibutramine, phenolphthalein thyroxine |
Losartan is a prescription drug used to treat high blood pressure while atorvastatin is a prescription drug used to treat high cholesterol. Losartan and atorvastatin should only be taken under the supervision of a health care practitioner.
Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke.
Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. Thyroxine is a thyroid hormone. Thyroid hormone preparations are prescription drugs used to treat hypothyroidism (low levels of thyroid hormones). Thyroid hormones should only be taken under the supervision of a health care practitioner.
According to the DH press releases:
Cardiotium was investigated by the DH after a local hospital authority reported an unexplained improvement in an 85-year-old patient's blood lipid profile. The DH ordered the company to recall the product from the Hong Kong market.
Paidusu and Tianran Zuanshi Xianweisu were investigated by the DH after a local hospital authority reported a 30-year old woman who had been taking these products sought medical treatment for hand tremor, palpitation, dry mouth, dizziness and shortness of breath. The symptoms subsided after she stopped taking the products.
SlimEasy Herbs Capsule was investigated after a 48-year-old woman was hospitalized for heart failure. The woman also reported shortness of breath and ankle swelling, and had been taking SlimEasy Herbs Capsule for about two years.
Side-effects associated with atorvastatin include serious muscle, kidney or liver injury, abdominal pain, diarrhea, headache and skin rash.
In addition to heart attack and stroke, side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.
Additional side-effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding. Side-effects associated with thyroid hormones include headaches, increased heart rate and blood pressure, chest pain, anxiety, tremors, sweating, difficulty sleeping, diarrhea and stomach pain.
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Media Enquiries:
Health Canada
613-957-2983
For more details on these Foreign Product Alerts, please visit the Health Canada Web site.
These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.
Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.
Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.
For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.
As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.