By Toni Clarke
April 26 Fraudulent versions of the wrinkle
treatment Botox, which is made by Allergan Inc and also
used to treat headaches, underarm sweating and overactive
bladder, are being sold in the United States, the Food and Drug
Administration said on Friday.
The FDA said in an alert posted on its website that the
outer carton of the fraudulent Botox is counterfeit, and the
vial inside is foreign and not approved for sale in the United
"FDA cannot confirm that the manufacture, quality, storage,
and handling of these products follow U.S. standards," the
The agency said the products could be counterfeit,
contaminated, improperly stored and transported, ineffective and
Allergan said that in addition to violating federal law,
products that are illegally imported may either be counterfeit
or the quality may have been compromised.
Authentic Botox is stored and transported by Allergan
according to rigorous specifications, the company said.
Botox is a sterile, purified version of the same toxin that
causes botulism, which can cause potentially deadly swallowing
and breathing difficulties, and when injected, acts to
temporarily smooth certain frown lines. It generated sales in
2012 of $1.77 billion, of which roughly half came from cosmetic
The FDA said the fraudulent Botox is being sold under the
names "Online Botox Pharmacy," "Onlinebotox.com" and
"Onlinebotox." The FDA said it did not appear that the
fraudulent product was being sold over the Internet, but that
sales had been solicited via fax, by offering prices below those
of FDA-approved products.
In 2004, four people were hospitalized with poisoning after
being injected with unapproved botulinum toxin, which a doctor
had passed off as Botox.
The case prompted a wide-scale investigation of more than
200 clinics throughout the United States and resulted in dozens
of convictions of people who injected patients with unapproved,
cheaper substitutes for Botox.
As recently as last December, the FDA alerted more than 350
medical practices that they may have received unapproved
medications, including Botox, from a foreign supplier.
The FDA's alert comes as lawmakers are seeking to create a
national set of standards for tracking prescription drugs
through the distribution chain to help prevent counterfeit or
contaminated products from reaching the public.
The U.S. House of Representatives and Senate each released
draft drug-tracking bills this week. The House draft would
require drugs to be traced, but only in lots, that can contain
thousands of individual packages. The Senate bill would require
each individual drug unit to be traceable.