The US FDA has written to over 350 medical practices about unapproved versions of Botox as well as other medications they may have purchased from a foreign supplier.
The FDA (Food and Drug Administration) says these products may be contaminated, counterfeit, ineffective, unsafe, and/or wrongly stored and transported. Patients could be placed at risk if medical practices purchase and use illegal and unapproved medications from foreign suppliers on their patients; effectively depriving them of safe and proper treatment, the Agency added.
The FDA requests that medical practices which bought the unapproved versions of Botox and any other products from suppliers owned by Canada Drugs, stop administering them to their patients. The following distributors belong to Canada Drugs – Bridgewater Medical, Clinical Care, A+ Health Supplies, and QSP (Quality Specialty Products).
Many, and possibly all the products these suppliers sell and distribute have not been approved by the FDA, making it impossible for the Agency to confirm that the manufacture and handling of these medications and Botox versions follow US regulations, or that they are effective and safe for clinical uses.
Unapproved medications may also not have the required labels that ensure their safe and appropriate use. For example, the botulinum toxin (Botox) products might not have the boxed warning or Medication Guide that the FDA requires for its approved botulinum products. There is a risk that doctors might not be fully informed regarding the potential serious risk of harm, or even death from the use of these products.
The health care community should examine its purchasing practices carefully to make sure that products are bought straight from the manufacturer, or from wholesale drug distributors in the USA which have a state-license.
The FDA wrote “Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them.”
Any suspected criminal activity should be reported to the Office of Criminal Investigations (OCI) by phoning 1-800-551-3989, or via the OCI Web Site.
Verifying wholesale drug distributor license – to find out whether a wholesale drug distributor is licensed to sell in your state (or where it is conducting business), go to this FDA web page.
Written by Christian Nordqvist