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Foreign Product Alert: 24 foreign health products found to contain undeclared drug ingredients

OTTAWA: These foreign health products have been found by regulators in the United States, Singapore, Australia and Hong Kong to contain undeclared drug ingredients, which may pose serious health risks.

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible that they may have been brought into the country by travellers or purchased over the Internet.

What you should do

Contact Health Canada at 1-800-267-9675 or complete an online complaint form if you find a product listed above in the Canadian marketplace.
Consult a health care professional if you have health concerns related to the use of any of these products.
Read product labels before making a purchase to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM).

Background

Prescription drugs should be used only under the supervision of a health care professional.

Benproperine is an ingredient used as a cough suppressant. Benproperine is not approved for use in Canada. Side effects associated with benproperine include sleepiness, dry mouth, abdominal pain and rash.

Bisacodyl is a stimulant laxative used in over-the-counter drugs to treat occasional constipation. Common side effects may include stomach discomfort or cramping, nausea and diarrhea.

Clenbuterol is a veterinary drug used to treat respiratory diseases in horses. It is not authorized for human use in Canada. Serious side effects include seizure, heart attack, psychosis or damage to skeletal muscle. Other side effects include irregular heartbeat, increased blood pressure, tremors, nervousness, nausea, increased blood sugar, headache and dizziness.

Diphenhydramine is an antihistamine used to treat allergies. It is also found in some cough and cold products and sleep aid medications. Side effects associated with diphenhydramine include drowsiness, dizziness, nausea, headache and dry mouth.

Mycophenolic acid is a drug that inhibits the normal response of the immune system. It is used to prevent organ rejection in patients receiving kidney transplants. Common side effects include nasopharyngitis, high or low blood pressure and abnormal blood test results. Use of mycophenolic acid increases the risk of infection, and long-term use may result in an increased risk of lymphoma. Use of mycophenolic acid during pregnancy is associated with increased risk of pregnancy loss and birth defects.

N-desmethyl sibutramine is similar to sibutramine, a drug previously used to treat obesity. Sibutramine 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. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. Additional side effects include decreased blood pressure, skin rash and gastrointestinal bleeding.

Sennosides are the active ingredients in some over-the-counter stimulant laxatives used to treat constipation. Side effects include stomach discomfort or cramping, nausea and diarrhea.

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. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerin) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Tadalafil is a prescription drug used to treat erectile dysfunction. Tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Report a health or safety concern

To report a side effect to a health product to Health Canada

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

As of August 6, 2019, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

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Foreign Product Alert: 24 foreign health products found to contain undeclared drug ingredients


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