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Why is the FDA pushing for more products like Botox? Is it not safe?

Dr. Dean Kane Q & A. Q. The FDA announced today that they want to help bring botulinum products similar to Botox to market faster, both due to the high demand for these products and to find one that “reduces the risks of inadvertent injections” and address various “safety concerns related to the potential for local and distant spread of toxin effect”. This seems like a ridiculous drug/treatment to be funding since Botox is currently so popular. Does this mean they consider it too high risk?  Opinions? A. Botox(R), is developed, researched, studied and made by Allergan for cosmetic and therapeutic indications. It is one of the most extensively studied drugs in world history. It has a miniscule complication rate. While millions and millions of people are injected yearly with Botox, there are till others who are afraid that they are being injected with the actual bacteria and therefore too afraid to have the injections performed. This drug is purified to reduce complications and has no live bacteria. Let me say this again, Botox is a serum produced by the bacteria, but there are NO LIVE Bacteria injected into the face. The only way you can get Clostridium Botulinum is if you were injured like on a rusty can that may contain the bacteria.  The bacteria which makes this toxin enters from a skin injury or is consumed, it is the reproducing bacteria in the blood stream that make millions and millions of units of neurotoxin to produce the effects of botulism poisoning. The serum used in Botox again does NOT contain any live bacteria, it is a purified drug cosmetically created for functional and cosmetic purposes. The FDA is responsible for protecting and promoting the public health through the regulation and supervision of drugs, devices and other products. It analyzes and approves only the indications requested by a manufacturer for the marketing of the product according to safety and efficacy standards. To my knowledge, the FDA does not promote the expansion of any class of product(s). When a manufacturer wishes to introduce a product into the US, it must also provide the science in safety and efficacy for the indications it wishes to market. The FDA has a shortened process for approval when it is similar to a product already on the US market. Dysport, Xeomin and Myobloc are available in the US under this process. The webpage you have referenced indicates to me that the FDA is using this shortened process to provide the ability to market other neurotoxins, from other manufacturers for cosmetic use in the US market. I hope this has been helpful. Sincerely, Dean Kane, MD, FACS
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