FDA Urges Docs to Buy Botox Made in the USA
December 28, 2012
In a recent news article, we cautioned consumers about purchasing discount Botox from websites like Groupon and Living Social. “Most commonly the products are diluted, so the effect is less than optimal.” According to the American Society for Aesthetic Plastic Surgery (ASAPS), risks associated with unlicensed filler range from dangerous reactions to outdated or ineffective products.
Now the U.S. Food and Drug Administration has followed up with a warning to doctors: “The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned and extra caution should be taken when considering them.” In other words, it is your doctor’s job to make sure products are full strength, uncontaminated and properly stored and manufactured.
On December 19, 2012, the FDA warned 350 medical practices that they may have received unapproved versions of Botox from a foreign supplier. The problem with unlicensed Botox from foreign shores is that such medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.
Further, unapproved meds may lack the necessary FDA-required labels that ensure appropriate, safe use and be boxed without the warnings or medication guides required for botulinum toxin products. Without this labeling, health care practitioners and patients will not be fully informed of potential risks or side effects from inappropriate use of these products.
The FDA warning strongly discouraged purchase of products received from foreign suppliers owned and operated by Canada Drugs, known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. With these unapproved products, the FDA cannot guarantee that their manufacture and handling follow US regulations and that the medications are safe or effective. FDA advice to doctors who have such products is to simply stop administering them.
It is the job of healthcare professionals and consumers alike to make sure that your syringe of Botox contains a safe and effective product. The Botox manufacturer, Allergan, says that legitimate Botox containers always contain the word ‘cosmetic’. Boxes and vials missing the 'cosmetic' label may be real Botox, but are not approved for cosmetic use in the United States.
Don’t hesitate to ask your doctor exactly what you are being injected with. Further, even with the FDA-approved product, all Botox injections are not equal. It takes a board-certified practitioner in an appropriate specialty with extensive training and experience to deliver the best results.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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