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FDA Cracks Down On Botox Scammers

Posted by Chrissie Cole
Thursday, August 14, 2008 10:15 PM EST
Category: Major Medical
Tags: Botox, Toxic Substances, FDA and Prescription Drugs, Defective Drugs, Cosmetic Surgery, Medical Malpractice, Medical Devices



IMAGE SOURCE: © iStockPhoto / Botox beauty treatment / mschenk

In November 2004, the Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI) was called in to investigate an illegal Botox scam.

Four people were hospitalized with botulism poisoning and temporary paralysis following injections with what they thought were Botox Cosmetic at a medical clinic in Florida.

The doctor administering the injections claimed the toxins used were Botox Cosmetic, made by Allergan, and currently the only FDA-approved botulinum toxin Type A, used to diminish wrinkles between the eyebrows.  

Botulinum toxin, in any form, is not permitted for commercial distribution without FDA approval.

As of July 2008, the OCI has made 68 arrests and 29 convictions of individuals who deliberately used unapproved, cheaper injections as a substitute for FDA-approved Botox Cosmetic in nearly 1,000 unknowing patients.

OCI agents traced the Botox products used in the Florida clinic to a California laboratory that sold the toxin for research purposes. Several more of the same products were found at Toxin Research International Inc. (TRI), located in Tucson, Arizona.

TRI was distributing the unapproved products to health care professionals as cheaper alternatives to Botox Cosmetic. OCI agents seized the products along with marketing materials from TRI in December 2004.

Several TRI associates have been arrested, including the company president. During the investigation into TRI’s involvement, OCI agents found shipping records that unveiled more than 200 health care professionals nationwide, from Las Vegas to Manhattan, who allegedly bought the unapproved drugs from the company.

As a result of the ongoing investigation, many doctors have been prosecuted and some are currently serving time in federal prison.

Botox is also used off-label to to treat several health problems, including headaches, backaches, excessive sweating (hyperhidrosis) of the hands and feet. It is approved for underarm hyperhidrosis as well as some neurological and muscle disorders. 

Botox Injection Safety Tips

» First and foremost, ask questions. If the doctor is unable to supply you with answers, look for a new doctor. What product are you being injected with? Is it an FDA-approved product that has been purchased in the United States?

» Prior to receiving an injection, disclose any and all medications you are currently taking including over-the-counter-drugs and vitamins.

» Make sure you fully understand the risks and benefits associated with the procedure beforehand.

» Botox Cosmetic should be administered in an appropriate setting by a trained and qualified health care professional.

In January, the public interest group, Public Citizen asked for a black-box label warning on Botox Cosmetic after 16 deaths were linked to the use of the toxin.

And this spring, a study published in the Journal of Neuroscience by researchers at the University of Padova in Italy found that after injecting botulinum neurotoxin type A near rats’ whiskers, the toxin moved to the brain stem, appears to disrupt nerve cells' ability to communicate and may change spinal cord circuitry, the authors wrote.

Those changes continued to be observed up to six months after the injection.

Allergan, makes about $1.2 billion a year from Botox Cosmetic which the drug maker claims has been used by 15 million around the world. Allergan says the product is purified, highly diluted, and safe. #

1 Comment

Anonymous User
Posted by Karen
Saturday, August 16, 2008 10:37 AM EST

For info on safe botox, check out more about Botox and Botox Cosmetic, locate Botox physicians near you, visit LINK

Comments for this article are closed.

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