OTTAWA - Health Canada is warning consumers not to use the dietary supplements 6-OXO (4-androstene-3,6,17-trione) and 1-AD (1-androstenediol), or any other supplements containing the ingredients 4-androstene-3,6,17-trione or 1-androstenediol, due to potentially serious health risks such as seizures and blood clots in the brain that can lead to disability.
Both 6-OXO and 1-AD are manufactured by ErgoPharm / Proviant Technologies in Champaign, Illinois. They are promoted as dietary supplements for body building, and are not authorized for sale in Canada. Health Canada has received one domestic adverse reaction case report in which an individual with no known predisposing medical conditions developed seizures and blood clots in his brain, associated with the use of 6-OXO and 1-AD.
6-OXO, which contains the compound 4-androstene-3,6,17-trione, is an unauthorized natural health product in Canada. 1-AD contains 1-androstenediol, an anabolic steroid that is regulated as a controlled substance in Canada, meaning it should only be dispensed by prescription and used under the supervision of a health professional. While neither product is authorized for sale in Canada, Canadians can access them over the Internet or purchase them while travelling abroad. The above-mentioned Canadian adverse reaction case involved a consumer who purchased the products in the U.S. and brought them into Canada through personal importation.
Consumers using 6-OXO, 1-AD, or other supplements containing 4-androstene-3,6,17-trione or 1-androstenediol without a prescription, are advised to stop taking the products immediately and consult with a health care professional if they have health concerns. Health Canada is taking action to prevent further importation of 6-OXO and 1-AD into Canada.
Health Canada is also reminding consumers to be cautious regarding the purchase of health products over the Internet or from outside of Canada, as these products may not have been assessed to the same standards as products approved for sale on the Canadian market. Authorized health products will bear either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Drug Number (DIN-HM). This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Consumers should contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find 6-OXO or 1-AD or any other supplements containing 4-androstene-3,6,17-trione, or 1-androstenediol being sold at a Canadian retail outlet without a prescription.
Consumers requiring more information about this warning can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
E-mail: [email protected]
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.
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