FDA Warns of "Fraudulent Versions" of Botox
FDA is reporting on its Web site that "fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices." According to FDA, these products are being sold under the company names “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox,” but they do not appear to be sold online. The discounted products rather are being promoted via fax, FDA reports.
FDA's recent warning isn't the first time the agency has pointed out risks from unapproved Botox products. In 2004, FDA began investigating cases of severe botulism poisoning reportedly caused by injections of "unapproved botulinum toxin," the agency reported in a Consumer Update. The investigation lead to several arrests and convictions.
The most recent warning centers on products provided in vials "labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States," the agency reports. The outer carton is "counterfeit" and displays the active ingredient as “Botulinum Toxin Type A,” FDA reports. "The lot numbers and expiration dates on the outer carton and accompanying vial do not match."
FDA-approved Botox for injection (100 units/vial) made by Allergan lists the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. FDA has not found any indication that Allergan’s FDA-approved version is at risk, it reports.
Consequently, FDA advises consumers to "know what you are being injected with. Make sure your health care professional is using only an FDA-approved product purchased within the United States. If he or she refuses to give you this information, look for another health care professional," it shares in the Consumer Update.