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Beware of Fraudulent Botox

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Botox is one of the names for the neurotoxic protein called botulinum toxin, which in large doses causes botulism, a rare but serious illness caused by bacteria.

Botox currently has many uses, but is most commonly known for its cosmetic use of treating wrinkles, facial creases, lazy eye, uncontrolled blinking, and glabellar lines.  Botox in 2012 generated sales of $1.77 billion, with approximately half coming from cosmetic use.

Non-cosmetic uses for Botox are treatments for cervical dystonia, writer’s cramp, excessive sweating, achalasia, chronic pain, neuropathy, migraine headaches and overactive bladders.

Unfortunately for the many users of Botox in this country, the U.S. Food and Drug Administration reported last month that fraudulent versions of Botox are being sold in this county.  The FDA posted an alert on its website stating the outer carton of the fraudulent Botox is counterfeit, and it contains a foreign vial inside which is not approved for sale in the United States.

In a press release, the FDA said, “The FDA cannot confirm that the manufacture, quality, storage and handling of these products follow U.S. Standards.”

The Botox that has been approved in this country is made by Allergan Inc..  Allergan warned those healthcare professionals that were purchasing products from a non-Allergan supplier, that these products are illegally imported and may either be counterfeit or the quality may have been compromised, as well.

In 2004, four people were injected with unapproved botulinum toxin and required hospitalization.  In a wide scale investigation of more than 200 clinics throughout this country, dozens of people were convicted for injecting patients with unapproved, cheaper substitutes of Botox.

To prevent the use of counterfeit or contaminated products in this country, our elected officials in Washington are seeking to create a set of standards to be used nationally for tracking prescription drugs and medical products such as Botox through the distribution chain.

To read the FDA’s alert on Botox, go to the agency’s website: http://www.fda.gov/Drugs/DrugSafety/ucm349503.htm

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