Archive for November, 2009

Posted on 25 Nov 2009
Category: Fake Botox
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In November 2004, four people became paralyzed after purportedly receiving Botox Cosmetic injections at a medical clinic. They were hospitalized with severe botulism poisoning. The paralysis was temporary—a result of being injected with potent, unapproved botulinum toxin.

The FDA’s Office of Criminal Investigations investigated. As it turns out, about 30 doctors had injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.

These doctors ended up with their licenses revoked, paying restitution and fines, and serving jail time.

Think it can’t happen to you? Of course it can. Companies and websites are still out there, offering doctors cheap alternatives to FDA-approved Botox and dermal fillers such as Restylane and Perlane.

When you buy Botox, always make sure you are buying the real thing. You know how the saying goes – if it looks too good to be true, it probably is. If you buy Botox at prices that are significantly lower than the market price for the FDA-approved drug, you risk buying fake Botox that could injure your patients and land you in jail.

According to the FDA, Under federal law, no form of botulinum toxin may be commercially distributed for use on humans unless it has been approved by the FDA. At this time, Botox Cosmetic, made by Allergan is the only type of botulinum toxin approved by the FDA to temporarily soften the frown lines between the eyebrows.

Similarly to Botox, there are companies who offer doctors fake dermal fillers, including Restylane and Perlane. Those companies are marketing their products with slightly different names than the original, FDA-approved fillers. Don’t be one of those who don’t notice the “misspellings” and only see the price difference. These products are fake, and could be extremely dangerous for your patients. Those same companies often offer to sell deep chemical peel kits directly to consumers (!), which should be a HUGE warning flag for anyone browsing those websites.

Protect your patients. Protect yourself. When you buy Botox and dermal fillers, make sure you buy the real, FDA-approved drugs. Never allow yourself to fall for a scam or become tempted by extremely low prices. Remember: if it looks too good to be true, it probably is.

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When you buy Botox for treating your patient’s facial lines, remember that while the FDA has only approved the cosmetic use of Botox for treating eyebrow furrows, doctors have been successfully administering Botox for treating a number of other cosmetic problems, including crow’s feet, forehead lines, crepey necks and even sagging breasts.

Botox is injected into the facial muscles that create dynamic wrinkles – those formed over time by repeatedly frowning, raising the eyebrows, smiling, or squinting. Some doctors also use Botox to treat wrinkle around the mouth. The injections work by temporarily paralyzing these muscles.

Botox is not effective against other types of wrinkles, including wrinkles caused by heredity, smoking, sun exposure, and the effects of gravity. Other methods, including injecting dermal fillers such as Juvederm and Restylane, may work better to treat some of these conditions.

Off-label use of Botox is possible – and legal – because FDA-approved drugs can be used by licensed doctors off-label according to their best judgment. That includes using those drugs for indications other than the ones that led to FDA approval.

However, when you buy Botox for cosmetic off-label use, it’s important to use it responsively. When you administer Botox to treat a wrinkled forehead, crow’s-feet, the mouth area, and bands in the neck, your patient is exposed to higher doses of Botox than those in the studies that led to the FDA approval. Make sure you are conservative with your doses, and ask your patient to focus on the areas that bother her the most instead of tackling everything in one session.

Of course, when you buy Botox for any cosmetic use, you should also remind your patients that just like any medical procedure, Botox is not without risk, although complications are almost always mild and temporary.

Many doctors believe that it’s just a matter of time until the FDA approves Botox for some of the most successful off-label uses such as smoothing forehead lines. Until then, when you buy Botox for off-label uses, use your best judgment and remember that with conservative, correct use of Botox, you can make a real, positive difference in your patient’s self confidence and save them the high cost and risks of surgery.