Faux-Tox: Is there really fake Botox?

By Warren B. Seiler III MD

As one of the top injectors of Botox Cosmetic in Alabama, I have always purchased my Botox directly from Allergan Inc. which is the only legitimate producer of Botox in the US. I have found out over the last few years that there are an astonishingly large number of physician and non-physicians (yes non-physicians!) that are buying Botox from other sources, all of which are illegal.  Why? One reason and one reason only:  it’s cheaper. Now you know how some of “those places” can offer Botox at a lower price.

I get something by fax, mail or email all the time from something like a “Canadian Pharmacy” trying to sell me cheaper Botox (and even though buying it from Canada is illegal, it’s usually fake, expired, or from a foreign country). Don’t worry, I have never even considered it, but I am shocked at how often it occurs. I always report these companies to my contact at the DEA. The DEA has really started to investigate these issues.

So what is it if it’s not really Botox? It may just be water, or some fake powder. Years ago, there was a report of several patients almost dying after receiving research-grade toxin instead of the real product.

What should you do? Simply make sure your provider is only purchasing Botox from Allergan. Your physician should be able to give you the name of their Botox rep and/or an account number.  The FDA maintains a list of doctors that are known purchasers from outside the USA. It’s not just the cheaper places, you would be surprised that some very well-known providers are not buying real Botox.

The article below is straight from the FDA website and discusses the dangers of imported Botox.
FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices.  The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards.  These fraudulent products are considered unsafe and should not be used.

The company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” At the time this alert was issued, the company did not appear to be selling its products over the internet. Instead, the company has been using “blast faxes” to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a U.S. return address when sending packages to medical practices, even though the products are from foreign sources.

Medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.  Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.

FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.  Currently, there is no indication that Allergan’s FDA-approved version is at risk, and this product should be considered safe and effective for its intended and approved uses.

Suspect fraudulent products can be identified as follows:
the outer carton displays the active ingredient as “Botulinum Toxin Type A”; or
the lot numbers and expiration dates on the outer carton and accompanying vial do not match.

FDA is asking the public to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources:

Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
Report to OCI at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm1, or
Email – DrugSupplyChainIntegrity@fda.hhs.gov

Health care professionals and patients should report adverse events related to the use of any suspect medications to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:

Complete and submit the report online: www.fda.gov/MedWatch/report.htm2, or
Download form3 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

FDA has issued a series of alerts and letters to practitioners about the risk of buying medicines from foreign or unlicensed sources.

http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm4  and http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm299920.htm5

The Food and Drug Administration is committed to protecting public health by securing the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.

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