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By Jim Kouri
Posted 1:00 AM Eastern
February 18, 2008

For quite some time, the Food and Drug Adminstration received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses.

Although the FDA has not provided information on the number of alleged deaths due to the toxin, a private, public-interest group Public Citizen claims they've documented 16 cases of deaths due to botulinum products.

"The FDA immediately go on the defensive whenever they've failed to perform their primary function -- protecting Americans. Usually a private, public-interest group makes an allegation and FDA officials react. And to think Americans pay billions of dollars for that agency," said political strategist Mike Baker.

Botox is being hailed as the next best thing to the fountain of youth for those wishing to erase skin wrinkles. At first it was the miracle drug for the rich and famous, but today most Americans are able to afford these medical treatments.

The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases ended in tragic outcomes including hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.

While use of of the substance is recongnized as a cosmetic treatment, the use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the United States, according to the FDA.

But despite the FDA's limited approval of Botox Cosmetic, dermatologists and doctors routinely administer the drug for "off-label" uses such as treating "crow's feet" around the eyes and alleviating migraine headaches. Whenever used to treat wrinkles, Botox Cosmetic lasts only three to six months, which means that users must repeat the injection process at least twice a year to maintain their wrinkle-free face.

In an early communication based on the FDA's ongoing safety review, the agency claims the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the pharmaceutical products.

However, the adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults, although its use is common in European, South American, and Asian nations.

Botox, or Botulinum Toxin Type A, comes from the waste of the bacteria Clostridium Botulinum, the same toxic byproduct that causes botulism food poisoning. Botox works by blocking nerve signals between the brain and muscles, effectively paralyzing the muscles that cause wrinkles and certain medical disorders.

"Because Botox is produced from bacteria, it is created with varying levels of potency-some batches of the drug, in other words, are stronger -- and perhaps deadlier -- than others," claims Mike Baker.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, which may include difficulty swallowing, weakness and breathing problems. While acknowledging the dangers associated with the toxin, FDA officials are not advising health care professionals to discontinue prescribing these products.

According to officials at the FDA, their agency is currently reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions. So far, a report has not been forthcoming.

Meanwhile, the Humane Society has weighed in with their own report. According to their press release, "each batch of Botox must be tested before [being] released to doctors and dermatologists; to determine the right potency of Botox-the key ingredient of which is botulinum toxin, the most poisonous substance known to mankind-Allergan uses a highly questionable test known as LD50, whose sole purpose is to find the dose that kills 50% of the animals used in the test.

Public Citizen, non-profit watchdog group, asked US authorities to require the strongest possible warning, highlighted in a "black box," on Allergan Inc's Botox and Solstice Neuroscience Inc's Myobloc, according to an MSNBC report.

While the FDA has repeatedly denied any coverup or white-washing, little information is available publicly about the types of potency testing, if any, that the FDA requires on Botox. Repeated Freedom of Information Act requests by the Human Society, for instance, to the FDA yielded little pertinent information, according to officials

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As with most controversial medical and scientific debates, there are those who claim critics are overreacting epecially plastic surgeons and pharmaceutical corporations.

"If the mainstream media give this story the coverage it deserves perhaps it will actually save lives -- especially the lives of children who depend on adults to make decisions based on the best interests of those children," said Baker.

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But despite the FDA's limited approval of Botox Cosmetic, dermatologists and doctors routinely administer the drug for "off-label" uses such as treating "crow's feet" around the eyes and alleviating migraine headaches.