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After four people became paralyzed back in 2004 after receiving Botox Cosmetic injections at a medical clinic in Oakland Park, Fla., the FDA and Office of Criminal Investigations (OCI) were called to investigate.

The victims were hospitalized with severe botulism poisoning. Luckily the paralyses were temporary and the FDA found they had been injected with potent, unapproved botulinum toxin.

The doctor who injected the toxin contributed the incidents to the Botox Cosmetic, an FDA-approved drug to treat forehead wrinkles.

The initial investigation of a Florida medical clinic turned into 210 investigations of health care professionals throughout the United States.

The work has led to 68 arrests and 29 convictions of individuals who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.

Botox Cosmetic, which is approved by the FDA to temporary reduce frown lines, is a sterile, purified version of the same toxin that causes botulism, a severe form of foodborne illness. In both cases, the toxin is produced by the bacterium Clostridium botulinum.

The injectable form of sterile, purified botulinum toxin, when used in small doses, locally affects the muscles' ability to contract, smoothing out frown lines to make them smoother.

OCI agents traced the fake Botox Cosmetic to a California laboratory that sold botulinum toxin for research purposes. More of the laboratory's research product was found at Toxin Research International Inc. (TRI) in Tucson, Ariz. This company was selling the unapproved toxin to health care professionals as a cheaper alternative to Botox Cosmetic. OCI agents found vials of the botulinum toxin at TRI, along with marketing materials targeted to physicians that were labeled "For Research Purposes Only, Not For Human Use." Invoices and product information sheets carried the same warning. However, physicians who were buying the cheaper, unapproved product were increasing their profits by charging their patients the same fee as if they were using the FDA-approved Botox Cosmetic.

The president of the TRI Chad Livdahl and his wife, a co-owner were convicted of fraud and misbranding a drug and sentenced to nine and six years in prison. Other co-conspirators got lesser sentences.

Further more, OCI agents tracked down more than 200 health care professionals throughout the country who bought the unapproved drug from TRI. Many of these health care professionals have also been prosecuted and are now serving time in federal prison.

These health care professionals scammed the patients by misrepresenting them the fake product, leading them to believe they were receiving the real Botox Cosmetic. They used the following tactics:

• advertised in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic

• displayed a certificate indicating they had received training by the Botox Cosmetic manufacturer, when they had not

• informed patients they would be receiving Botox Cosmetic

• failed to tell patients they were getting a drug not approved for human use

• asked patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic

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As a victim of Botox and still suffering the after math of this catastrophic cycle of side effects, I empathise with any one who endures what I have for the past two years, it's a deadly toxin and more needs to be done to highlight this to people. I was once an active well person my health is plagued by side effects, I'm now aware the toxin can migrate to other parts of the body which it did causing me temporary breathing problems I received adrenalin and steroids, it also attacked my neurological system I had leg and arm movements, night sweats, anxiety panic attacks, fainting fits, crippling acid reflux and numbness and tingling down my face.. I had numerous tests all inconclusive bloods normal, the risks are not worth it do not even think about using this product for cosmetic reasons, buy a good fade cream or have a facial don't be naive like I was!
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