Keeping Canadians In The Know About Health And Consumer Product Safety

Main Category: Public Health
Article Date: 28 Jun 2008 - 5:00 PST

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The Honourable Tony Clement, Minister of Health, reminded Canadians of the important health product safety information that Health Canada provides on an ongoing basis - including Warnings and Advisories.

"Canadians need to be confident in the products they use," said Minister Clement. "While the vast majority of Canada's processors, importers, manufacturers and suppliers provide safe consumer, health and food products, there are cases where serious safety issues have been identified. Canada's new Food and Consumer Safety Action Plan will improve upon Canada's world class regulatory processes by targeting the small percentage of industry who behave irresponsibly. That means a more level playing field for law-abiding Canadian businesses and increased protection for the consumers they serve."

Health Canada issues Warnings in the most urgent situations, when there is a high probability that the use of, or exposure to, a product will cause death or other serious adverse health effects. The Department uses Advisories to inform the public of possible serious health hazards to enable Canadians to make informed decisions concerning the continued use of health products. These documents also describe compliance and enforcement actions taken by Health Canada, such as product recalls.

From January to June 2008, Health Canada issued 11 Warnings and Advisories on several drugs and natural health products. The Warnings and Advisories previously issued were as follows:

January 2008

Warning - Yeniujyn
Health Canada warned Canadians not to use this unauthorized product because it contains heavy metal contaminants and may pose a serious health risk. Yeniujyn is advertised as a natural health product, for adults and children, to be used "to cure involuntary passage of urine diseases." The product was found to contain high levels of lead and arsenic.

February 2008

Advisory - Fentanyl Transdermal Pain Patches
Health Canada advised Canadians not to use 25 mcg/hr Duragesic (fentanyl transdermal system) patches sold by Janssen-Ortho Inc. and 25 mcg/hr Ran Fentanyl Transdermal System patches sold by Ranbaxy. These patches were being voluntarily recalled by the manufacturer because they may have a cut along one side of the patch which could result in leaking of the fentanyl gel from the patch. These patches are prescription medications containing a strong narcotic for use in the management of persistent, moderate to severe chronic pain. Exposure to fentanyl gel that has leaked from the patch may lead to increased skin absorption and could result in serious, potentially life-threatening adverse events, including respiratory depression (slowed breathing) and possible overdose, which may be fatal.

March 2008

Warning - ADAM
Health Canada warned consumers not to use ADAM, an unauthorized product promoted for the treatment of erectile dysfunction, because it may pose serious health risks. ADAM contains an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil, which should only be used under the supervision of a health care professional. The product may pose serious health risks, especially for patients with pre-existing medical conditions such as heart problems, those who may be taking heart medications, or those who may be at risk for strokes.

Warning - Libidus
Health Canada warned consumers not to use Libidus, an unauthorized product promoted on the web site of the manufacturer for the treatment of erectile dysfunction. The product may pose serious health risks, as it was found to contain the undeclared prescription drug sildenafil, which should only be used under the supervision of a health care professional. Patients with pre-existing medical conditions, including those with heart problems, those taking heart medications, or those at risk for strokes, may be at an increased risk of serious health effects associated with the use of this product.

Advisory - Carbamazepine
Health Canada advised that patients of Asian ancestry using the epilepsy drug Carbamazepine may be at increased risk of serious skin reactions as compared to patients of non-Asian ancestry.

Advisory - Heparin
Health Canada advised Canadians that testing of heparin products marketed in Canada identified a contaminant in products from manufacturer B. Braun Medical Inc. The Department worked with the company on its recall of the affected Canadian products from the market. The contaminant, oversulphated chondroitin sulphate, has also been found in heparin products in the United States and Australia.

Warning - PediaCol
Health Canada warned parents and caregivers not to use a certain lot of PediaCol drops, a product for infants taken orally to relieve symptoms of excess gas associated with colic. The product, labelled with the lot number PDC701, was found to be contaminated with yeast and may pose serious health risks.

April 2008

Warning - Vigoureux
Health Canada warned consumers not to use Vigoureux, an unauthorized product promoted for the treatment of erectile dysfunction. The product may pose serious health risks, as it was found to contain the prescription drug sildenafil, which was not indicated on the label and should only be used under the supervision of a health care professional.

May 2008

Warning - Trophic Kelp and Glutamic Acid HCI
Health Canada warned consumers not to use the natural health product Trophic Kelp & Glutamic Acid HCI 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.

Warning - Desire
Health Canada warned consumers not to use Desire, an unauthorized product promoted to enhance male sexual performance, as this product may pose serious health risks in certain patients.

June 2008

Warning - 6-OXO and 1-AD
Health Canada warned consumers not to use the dietary supplements 6-OXO and 1-AD, or any other supplements containing the ingredients 4-androstene-3,6,17-trione or 1-androstenediol, due to potentially serious health risks associated with those ingredients, such as seizures and blood clots in the brain that can lead to disability.

Health Canada