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Health News
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At the heart of scientific research surrounding the testing of new drugs are the laboratory animals. These animals are the “guinea pigs” for every new medication that becomes available; the purpose is to educate researchers on potentially harmful side effects possibly related to that medication prior to consumer use. When Botox, a diluted form of botulism, was tested in the initial stages, the laboratory animals showed zero side effects that would trigger a belief that the toxin had reached their brain, researchers now believe otherwise. When this diluted form of botulism enters the brain, irreversible brain damage potentially may occur. The test animals did show signs of the Botox entering the bloodstream after facial injection and as long as the Botox was in the blood stream it was assumed that it could not reach the brain. Thus, in 1989, Botox was approved for human use.
Now, many years and millions of Botox injections later, the pre-clinical testing is now showing signs that the drug may actually seep into the brain. The pathway to the brain is one that researchers were not looking for and thus passed right by them in the animal trials. At the heart of the mistake were the Neurons at the injection site. When the Botox is injected into the face, the Neurons absorb a small amount of the toxin and then after migration to the brain stem, affected the normal Neuron activity. This path from face to brain took only 3 days.
These results are a complete reversal of all findings in the early studies that helped to move Botox from the trial stage to the clinical stage and eventually onto the market for human use. Scientists reported in the original studies that Botox was completely broken down while still in the facial tissue and any botulism agent that was absorbed would only enter the bloodstream with no chance of moving to the brain.
In an attempt to backtrack and figure out just how many people have been put in danger from the incorrect trial results, the FDA launched a safety review. During the review, many of the deaths associated with the use of Botox were linked to the useage for medical conditions and not cosmetic procedures. But, researchers do acknowledge that cosmetic usage does have the potential of causing death as well.
Many uses that Botox is prescribed for are not “approved” uses though the use of Botox for alternative treatments is completely legal in the hands of a licensed doctor. Patients seeking to use Botox to rid their faces of wrinkles and for other cosmetic procedures should cautiously use their best judgment based upon the evidence of possible Botox side effects.
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Last Updated on Friday, 19 December 2008 04:37 |