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      Public advisory - Unauthorized drug products sold illegally on Quadragen and Advanced Research websites may pose serious health risks


      News provided by

      Health Canada (HC)

      Jul 19, 2024, 16:38 ET

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      OTTAWA, ON, July 19, 2024 /CNW/ -

      Summary

      Bromantane_50mg_per_mL_Advance Research (CNW Group/Health Canada (HC))
      Bromantane_50mg_per_mL_Advance Research (CNW Group/Health Canada (HC))
      Bromantane_50mg_per_mL_Quadragen (CNW Group/Health Canada (HC))
      Bromantane_50mg_per_mL_Quadragen (CNW Group/Health Canada (HC))
      Noopept_20mg_per_mL_Quadragen (CNW Group/Health Canada (HC))
      Noopept_20mg_per_mL_Quadragen (CNW Group/Health Canada (HC))
      RU58841_50mg_per_mL_Advanced Research (CNW Group/Health Canada (HC))
      RU58841_50mg_per_mL_Advanced Research (CNW Group/Health Canada (HC))
      Bromantane_50mg_per_mL_Advance Research (CNW Group/Health Canada (HC)) Bromantane_50mg_per_mL_Quadragen (CNW Group/Health Canada (HC)) Noopept_20mg_per_mL_Quadragen (CNW Group/Health Canada (HC)) RU58841_50mg_per_mL_Advanced Research (CNW Group/Health Canada (HC))
      • Product: Unauthorized drugs sold on Quadragen and Advanced Research websites associated with the company Quad Inc.
      • Issue: Health products – Unauthorized product; Product safety
      • What to do: Do not use these products. Consult a health care professional if you have used them and have health concerns. Only buy prescription drugs from licensed pharmacies. Read product labels to verify that health products have been authorized for sale by Health Canada.

      Images

      Affected products

      Unauthorized injectable peptide drugs sold on Quadragen and Advanced Research websites associated with the company Quad Inc. Updated on July 19 to include additional unauthorized drugs.

      Issue

      UPDATE – July 19, 2024: After further review of the products seized from Quad Inc., Health Canada is expanding its warning to include additional unauthorized drugs. In addition to the injectable peptide drugs that Health Canada previously warned about, the following drug products were also being illegally sold on the Advanced Research and Quadragen websites and may pose serious health risks:

      • Bromantane and omberacetam oral drops promoted as "nootropics" on the company's websites. Nootropic drugs are synthetic drugs that may enhance mental and cognitive skills, however their precise effects are unknown. There are no drugs authorized in Canada for any use that contain bromantane or omberacetam.
      • RU-58841 topical drops applied to the skin promoted as a "selective androgen receptor modulator (SARM) for hair regrowth". The product is a nonsteroidal antiandrogen that blocks the effects of androgens (male hormones) like testosterone. RU-58841 is not authorized in Canada for any use.

      The background section below provides additional information on the health risks related to bromantane, omberacetam, and RU-58841. Should additional safety concerns be identified, Health Canada will take appropriate action to protect consumer health and safety and will inform the public as appropriate. 

      Original Advisory – June 26, 2024: Unauthorized injectable drug products sold illegally on Quadragen and Advanced Research websites may pose serious health risks

      Health Canada is warning consumers not to buy unauthorized injectable drugs from Quadragen and Advanced Research websites (www.quadragen.io/, and www.advancedresearch.bio/) because they may pose serious health risks. Unauthorized injectable drugs carry significant health risks due to the potential for infection, allergic reactions, and other poor outcomes.

      The two websites are associated with Quad Inc., a company located in Beloeil, Quebec. Health Canada seized injectable peptides, along with unauthorized bodybuilding drugs, from Quad Inc. At Health Canada's request, the company has stopped advertising and selling unauthorized health products, including taking down its Quadragen and Advanced Research websites.

      Peptides carry out a range of important functions in the body. Injectable peptide drugs are often marketed for bodybuilding, anti-aging, or enhancing athletic performance. Some peptides can be produced for use in medications. Most synthetic injectable peptides are regulated as prescription drugs in Canada and require a prescription from a licenced health care professional. Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects.

      Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, additives or contaminants that may or may not be listed on the label.

      Should additional safety concerns be identified, Health Canada will take appropriate action to protect consumer health and safety and will inform the public as necessary.

      What you should do

      • Do not use these products. Consult a health care professional if you have used them and have health concerns.
      • Only buy prescription drugs from licensed pharmacies and avoid buying health products from questionable or untrustworthy websites. Be aware of the risks of buying health products online.
      • Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste or return the product to your local pharmacy for proper disposal.
      • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
      • Report any health product-related side effects or complaints to Health Canada.

      Background

      Bromantane (also known as Ladasten) is a drug that is not authorized in Canada for any use and has not been reviewed by Health Canada for safety, effectiveness and quality. The long-term effects on the body are unknown. Anti-doping regulations have prohibited its use in sports. Bromantane has been tested in only a few clinical trials, and there is no information on dosing in humans or on any potential interactions with other drugs. In animals, high doses have caused vomiting, regurgitation, diarrhea, and increased urination. Bromantane has not been reported to cause withdrawal symptoms or addiction but some reported adverse events after discontinuation have included fatigue, depression, and confusion.

      Omberacetam (also known as GVS-111 and Noopept) is a drug that is not authorized in Canada for any use and has not been reviewed by Health Canada for safety, effectiveness and quality. The long-term effects on the body are unknown. One clinical study has shown adverse events such as increased sleep disturbances, increased blood pressure, irritability, and headache. The main concern with omberacetam is the limited clinical information for this drug. The highest tolerable dose, tolerance and dependence, and interactions with other drugs are all unknown.

      RU-58841 is a nonsteroidal antiandrogen drug that is not authorized in Canada for any use and has not been reviewed by Health Canada for safety, effectiveness, and quality. The long-term effects on the body are unknown. While information from clinical studies on the safety of RU-58841 is limited, side effects reported by users include allergic reactions, skin irritation, redness, itching, and dryness. Based on its mechanism of action, if absorbed in the blood stream, RU-58841 could cause fatigue, headache, dizziness, decreased libido, and erectile dysfunction. The main concern with RU-58841 is the limited clinical information for this drug. The highest tolerable dose, tolerance and dependence, and interactions with other drugs are all unknown.

      Également disponible en français

      SOURCE Health Canada (HC)

      Media Enquiries: Health Canada, (613) 957-2983, [email protected]; Public Enquiries: (613) 957-2991, 1-866 225-0709, [email protected]

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