Archived – Health Canada warns consumers not to use unauthorized intravenous health products due to potential health risks

Starting date:

October 13, 2006

Posting date:

October 13, 2006

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Unauthorized products

Audience:

General Public

Identification number:

RA-110001553

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Health Canada is warning consumers and health practitioners not to use the unauthorized intravenous products Bismacine (also known as Chromacine), Dioxychlor (also known as DC-3) and Sulfoxime because they may pose a serious risk to health.

These products have been promoted as an intravenous protocol to treat Lyme disease, a tick-bourne illness. Additionally, Dioxychlor and Sulfoxime injections have been promoted for the treatment of other health conditions. Together, Sulfoxime and Dioxychlor are promoted as anti-microbial agents.

Bismacine is not an authorized health product in Canada; however, it has been available for sale from compounding pharmacies in the United States. Bismacine contains high amounts of bismuth, a heavy metal that is authorized for use in some oral medications to treat Helicobacter pylori, a bacterium that can cause stomach ulcers. However, using bismuth through injection may result in cardiovascular collapse, kidney failure or death.

There is evidence that Dioxychlor and Sulfoxime, although not authorized by Health Canada, have been purchased by Canadians, in Ontario, Quebec and Nova Scotia, from a U.S. Internet pharmacy.

Bismacine, Dioxychlor or Sulfoxime injections are not recognized naturopathic practices in Canada and they are not used by licensed naturopathic doctors in Canada for the treatment of Lyme disease or any other condition.

All three products are manufactured by American Biologics of Chula Vista, California. The same manufacturer markets a device called the Bradford High Resolution Microscope as a tool to diagnose Lyme disease. This device has not been reviewed or approved by Health Canada.

Lyme disease occurs mainly during the summer. It is treated with antibiotics, either orally or intravenously, depending on the severity of the disease. Visit the It's Your Health fact sheet for more information on Lyme disease.

To date, no adverse reactions suspected to be associated with these products have been reported to Health Canada. However, there has been one death and several reports of injury related to treatment with Bismacine in the United States.

Health Canada is advising consumers and health practitioners not to use Bismacine, Dioxychlor or Sulfoxime for the treatment of any medical condition, including Lyme disease. Individuals who believe they have suffered side-effects from using these products are advised to seek medical attention immediately. Health Canada is also advising consumers and health practitioners not to use the Bradford High Resolution Microscope to diagnose any medical condition.

Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to these or any other health products, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada website.
 

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613-957-2983

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613-957-2991
1-866-225-0709

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