This news is putting a scare into the pharmaceutical cosmetics industry.
The U.S. Food and Drug Administration (FDA) has written a warning letter to more than 350 medical practices about a bogus Botox that may have come from a foreign source distributed through Canada.
The product may be contaminated, counterfeit, stored improperly and basically unsafe. Patients injected with the unapproved version of Botox frown eraser could suffer adverse effects from its main component, botulinum toxin, which can be fatal.
The letter went out to doctors across the U.S. including 28 clinics in Florida.
The California-based company, Allergan, owns the trademark on Botox cosmetic. Allergan received FDA approval in December 1989 for the injectable as a treatment of strabismus (eyes misaligned), blepharospasms (eye twitches), and hemifacial spasm in patients over the age of 12. Botulinum toxin blocks the nerve-muscle transmission essentially freezing the frown.
Botulinum toxin type A is now known as Botox Cosmetic used to improve the frown lines between the eyebrows known as the glabellar lines. It is also used to treat excessive sweating. The American Society of Plastic Surgeons estimates 4.6 million procedures are done in the U.S. every year.
The contaminated cosmetic may be distributed by CanadaDrugs.com, a Winnipeg-based online supplier which has been a focus of FDA investigators for years. Phony Avastin was shipped to cancer clinics through companies associated with CanadaDrugs.com.
Medical News Today reports the following distributors are owned by Canada Drugs – Bridgewater Medical, Clinical Care, A+ Health Supplies and QSP (Quality Specialty Products).
Clinics are being told to double check to make sure the product comes from Allegan or distributors with a state license. Doctors who received the letters are asked to stop administering the unapproved versions of Botox.
The Office of Criminal Investigations (OCI) researches criminal conduct concerning drugs and medical devices that have FDA approval. They can be contacted at 1-800-551-3989.
Doctors may want to take this warning seriously. A Tennessee doctor is facing three years in jail and a $250,000 fine after he bought counterfeit drugs from a Canadian wholesaler and charged full price to federal health programs in the U.S.