As reported by the FDA, the botulinum toxin, a primary ingredient in in Botox injections, has killed at least 16 people when the toxin spread to other parts of their bodies.

 

The deaths are cited in a petition by the group Public Citizen to have a “black box” warning about this risk placed on the packaging of Botox and related medications. The highest warning level that the FDA can give a product without removing it from shelves is called a black box.

 

Botox made by Allergan and Myobloc from Solstice Neuroscience are a few of the injections that you can receive based on the botulinum toxin, which stops nerve impulses from getting to muscles, in turn making them relax. These two drugs are medically approved for the treatment of cervical dystonia, which often results in tough or spastic neck muscles. Botox is known by more people as a way to smooth out face wrinkles.

 

According to Public Citizen’s review of 180 reports of adverse effects reported to the FDA, at least 87 people have been hospitalized and 16 killed due to a spread of the toxin beyond the injection site. Side effects of the toxin include muscle weakness, trouble swallowing, or even aspiration pneumonia. Four of the people who died from the injections were children.

 

While the prescribing instructions for both medications mention the risk that botulinum toxin can spread and paralyze other parts of the body, the warnings are easy to miss, said Sidney Wolfe, director of the Public Citizen Health Research Group. Public Citizen has said that the Food and Drug Administration should outline the risks with a block box warning while requiring doctors to also hand out a guide to patients before administering these injections. 

 

“These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear, and could prevent more serious complications, including death,” the FDA says.

Unfortunately, Botox received from one cosmetic procedure provider may not be exactly what you get at another. Even though Botox (botulinum toxin type A) is supplied to all doctors and facilities in a manufacturer’s vial containing 100 units of vacuum-dried neurotoxin complex, in order to be able to inject these active units of Botox, a physician must add a saline solution to get it in “liquid form.”

There are 100 units of Botox in every vial, and the more saline that is added to the vial, the less active units that will be present in each syringe. You should be aware that some may refer to this as the dilution process, but it is actually called “reconstitution.” So while each healthcare professional gets the same Botox product from the manufacturer, when it’s reconstituted for injection, strength and efficacy will differ depending on the amount of saline added. This brings to mind a number of questions for you to ask yourself before deciding on Botox injections.

With this in mind, you should be cautious when you see Botox offered at bargain prices. Everyone pays the same price to the vendor (Allergan) - so how can prices to patients vary so much? It doesn’t seem reasonable, does it? That’s because it isn’t, if manufacturer’s recommended reconstitution guidelines are followed. Botox at a “bargain” price almost always means it has been diluted far beyond what’s recommended (or effective).

A patient may assume that he or she is getting a “good dose” of Botox because the physician is injecting a large amount - but don’t confuse units of saline with units of actual Botox. Physicians who add more saline to the Botox vial than is suggested by the manufacturer, or by the American Society of Plastic Surgeons (ASPS), are administering a less effective injection of Botox - so you should always ask, “What is your reconstitution ratio?”

Also, some facilities quote a price based on the area of injection. You need to look further into this vague statement. As well as asking about the reconstitution ratio, you also need to ask a second important question, “how many units do you inject in that area?”

And, that begs the next question — what is their definition of an “area”. For instance, a provider may advertise “$99 per area”, but if the crow’s feet area is broken up into two areas, when in most practices it is considered one area, you’re not getting any bargain. Look, instead, for a dermatologist or plastic surgeon that charges for Botox “by the unit” so you only pay for the exact number of units you receive. Be sure that he or she follows ASPS guidelines on reconstitution, as well.

If you’re considering Botox, you want to be as educated as possible and do plenty of research before going ahead with the injections. Being the well-informed consumer of these products means being aware of exactly what is being used in your cosmetic treatment, whether the person administering your cosmetic treatment is qualified, and last, but not least, if you are even a candidate for Botox injectables.