Undeclared drug ingredients may pose serious health risks

Starting date:
April 30, 2019
Posting date:
April 30, 2019
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-69796

Last updated:

Products Alerts

These foreign health products have been found by regulators in the United States and Australia 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 they may have been brought into the country by travellers or purchased over the Internet.

Unauthorized Foreign Health Products
Product name Hazard identified Details Photo
U.S. Food and Drug Administration - United States
Slimina Undeclared sibutramine Weight loss capsules
The Silver Bullet Undeclared sildenafil and tadalafil Sexual enhancement capsules
Therapeutic Goods Administration - Australia
Germany Black Ant  Undeclared sildenafil Sexual enhancement 2000mg tablets
OA/RA capsules Aristolochic acid contamination Pain relief for osteoarthritis

What you should do

  • Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace.
  • Consult a healthcare professional if you have health concerns related to the use of any of these products.
  • Read the label of the products you buy 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 a Homeopathic Drug Number (DIN-HM).

Background

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

Aristolochia refers to a group of plants that contain aristolochic acids, which are naturally occurring toxic substances. Health risks associated with the use of health products containing aristolochic acids include kidney failure and cancer.

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 and Tadalafilare prescription drugs used to treat erectile dysfunction. Sildenafil and Tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as they 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 health or safety concerns

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 April 3, 2019, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

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