Cardiotium, Paidusu, SlimEasy Herbs Capsule, and Tianran Zuanshi Xianweisu

Starting date:

January 25, 2012

Posting date:

January 25, 2012

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance

Audience:

General Public

Identification number:

RA-120001754

• 
  Images

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.

Source of alert

Hong Kong Department of Health

Product names

• Cardiotium
• Paidusu
• SlimEasy Herbs Capsule
• Tianran Zuanshi Xianweisu

Manufacturer / Place of origin

Cardiotium is imported and sold in Hong Kong by Ocean Pharmaceutical (HK) Limited.

Paidusu is manufactured by Sheng Run Ke Ji Kai Fa You Xian Ze Ren Gong Si.

The manufacturer of SlimEasy Herbs Capsule is unknown.

Tianran Zuanshi Xianweisu is manufactured by Ha Sheng Run Ke Ji Kai Fa You Xian Ze Ren Gong Si.

Product description

Cardiotium is promoted as a traditional Chinese medicine used for managing hypertension (high blood pressure), blood lipid (fat) levels and coronary heart disease.

Paidusu is promoted for weight loss.

SlimEasy Herbs Capsule is promoted as a natural health product used for weight loss. 

Tianran Zuanshi Xianweisu is promoted for weight loss.

Reason for warning

The Hong Kong Department of Health (DH) warned consumers not to use these products after they were found to contain the following undeclared pharmaceutical ingredients.

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.

Possible side effects

Side effects associated with losartan may include fatigue, hives, swelling of the face, and/or throat, dizziness, and muscle pain. Losartan use during pregnancy can cause injury and even death to the fetus. Consult a health care practitioner immediately if you have taken Cardiotium while pregnant.

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.

What you should do

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. 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.

Background

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. 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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983 

Public enquiries

613-957-2991

1-866-225-0709

Images

Select thumbnail to enlarge - opens in a new window