FDA warns doctors of counterfeit Botox
WASHINGTON (AP) — Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.
The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.
In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.
A request for comment from the drug distributor was not immediately returned.
Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.
Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG's Genentech unit.
The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.
In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.
A request for comment from the drug distributor was not immediately returned.
Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.
Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG's Genentech unit.
The manufacturer of that wrinkle treatment should take their product back to FDA unless they really want to ship it illegally. If they want to prove that their product is safe then they should do it very soon.
-Ms. Tille
I am very grateful that you continue to report on this type of egregious medical practice. There are many of my collegues that do not realize that it is not only dangerous but ILLEGAL to import pharmaceuticals for use in their practices. Living Social, Groupon and other resources like this have really made this practice come to light. I ran accross a Living Social for a practice offering some ridiculously low unit price for Botox. The practitioner was getting the product from outside the country and injecting it into her clients with dubious results. If it sounds too good to be true...BUYER BEWARE, it is too good to be true.
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If you want to be sure that you are getting real Botox go to someone that you trust and whom you establish a relationship. My clients come to see me and KNOW that I will treat them with love and respect and only provide them real Allergan Product. My clients get their "points" from Brilliant Distinctions and continue to come back becasue they know that they are getting the real product from me. Ask your provider about Brilliant Distinctions! Ask to see the original vial that they drew their product from or better yet ask to see them draw it up. Your face is too valuable and too important to go to someone you "found on some discount site."
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Botox should cost between $10 - $15 dollars per unit. If it costs less than that I wonder about the business practices, business model and possibly the ethics of that pracitce. Sometimes if you pay in advance you can buy 100 units for $10 per unit but generally, you can expect to pay somewhere around $12 per unit as a fair market cost.