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34 Essentials of neuromodulation
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events were minor comparatively speaking to other treatments such as
dermal filler implantation.
Caution with the silicone stoppers
It is thought that when the needle punctures through the silicone stopper of
the BoNT-A bottle with the same needle intended for injection that the
needle becomes infiltrated with silicone molecules, which is then inadvertently injected into the patient’s tissue. Silicone can create a foreign body
reaction within the patient’s tissue and have adverse long term sequela. Some
research has identified that the presence of silicone granulomas and siliconoma can be the direct result of utilizing the same needle that has gone
through the silicone stopper (Stone, Zhu, Thach, & Ruegg, 2011).
Possible side effects with
*Swelling at the injection site
*Bruising at the injection site
*Discomfort (temporary) at the injection site
Dry mouth
Tenderness in the neck
*Headache
Double vision
Dizzy
*Faint
Itching
Rash
Wheezing
Asthma flair
Allergic reaction
Hives
*Indicates the most common yet benign side effects
Possible emotionally charged side effects
Not effective
Not strong enough
Results not as expected
ALL neuromodulators
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Contraindications with the use of ALL neuromodulators
(Absolute contraindications)
1. Hypersensitivity
Hypersensitivity to any botulinum toxin preparation or any of the components in the formulation. Severe and immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum
sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction
occurs, further injection of botulinum toxin should be discontinued,
and appropriate medical therapy immediately instituted. One fatal case
of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently, the causative agent cannot be reliably
determined.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
2. Infection or rash
Active infection or rash at the injection site is generally a contraindication in almost any esthetic procedure unless, of course, the injectionist is
treating the complication.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
3. Pregnancy or lactating
Currently, neuromodulators are listed as a pregnancy category C. There
have been reports that woman have inadvertently received neuromodulation while pregnant, and to this date, no teratogenicity has been
reported. The reported cases have had uneventful deliveries. Given
the procedures’ elective nature and that, proper research has not been
performed to concretely demonstrate pregnant and lactating women’s
safety. In animal studies, fetal abnormalities were reported in the growth
and development phases of pregnancy. It was reported that a decrease in
fetal weight along with skeletal ossification occurred. The expert opinion
is that it is not worth the patient’s risk, the unborn fetus, or a professional’s license to treat a known pregnant or lactating mother.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
4. Allergy to cows milk protein with the use of Dysport is an absolute con-
traindication. A true cows milk allergy is different from what most people will report as an allergy to milk, otherwise called lactose intolerant.
Dysport is formulated with a trace amount of a protein that is contained
in cows milk. Therefore, if the patient is allergic to cows milk, they may
not receive Dysport.
(Dysport, 2020)
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5. If the patient has a known sensitivity to human albumin, they may not
use any commercially available neuromodulators as it is reported that
they all contain human albumin. Even though there is a warning of
the possibility to spread viral diseases such as Creutzfeldt Jakob disease
(a fatal brain degenerative disease), there has not been a single reported
case of the transmission to date. It only comes as a warning at this point to
injectors. The idea that neuromodulators contain human byproduct is
also an essential piece of information or point to make for particular religious preferences. Individual religious preferences will not want any
injections or consume anything that has components of another human.
It is advised to specifically ask about someone’s religious preference so
that the provider can be sure that they are appropriately educated and
treating the patient according to their beliefs.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
6. Neurological disorder such as:
• Amyotrophic lateral sclerosis (ALS, aka Lou Gehrig’s disease)
• Myasthenia gravis
• Lambert Eaton
The use of any neuromodulators may very well exacerbate the clinical
effects. Individuals with peripheral motor neuropathic diseases may be at
an increased risk of clinically significant effects, including generalized muscle
weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and
respiratory compromise from any of the commercially available neuromodulations. Typically patients with these types of delimitating diseases are not
seeking out treatment for esthetic reasons. With that said, medicine is changing so rapidly, and lives are being extended, and cures are happening daily.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
Contraindications for the injector t o consider
1. Thick sebaceous skin—Thick sebaceous skin can be prohibitive in
achieving beautiful results with neuromodulators. The thick skin limits
the ability to substantially minimize glabellar lines with the use of neuromodulation. Patients with thick sebaceous skin will often need more
neuromodulation than the average dosing along with concomitant treatments such as skin resurfacing, prescription-strength skincare such as ZO
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Skin health. DCCM™ strictly uses the ZO Skin health line because it is
aggressive yet promotes skin health. The focus should be on the whole
patient, not just one wrinkle.
2. Prior CO
resurfacing or eye surgery is undoubtedly cause for pause. It
2
is essential to stop all neuromodulators 3 months before the patient’s
eyelid surgery. The surgeon must have a complete and proper scope
of the patines natural and unoppo sed facial function. A patient who
has recently had a CO
treatment or aggressive skin tightening treat-
2
ments also causes pause. Allowing the patient to have ample healing
time is necessary. The skin can be swollen and tight, with some of these
procedures masking the muscle movement’s accurate anatomical
representation. They are also at greater risk of infection during their
healing phase. A slow restorative journey is typically the safest for
the patient and the provider.
3. Upcoming special events—This is a problematic situation as many
patients come in a little too late to have things done. It is a common misconception that esthetic services deliver quick results. The continued
misconception is that they are relatively inexpensive and do not pose
any risk of downtime. The harsh reality is that neuromodulation comes
with the risk of bruising and takes 2 weeks to heal. The minimal risk of
bruising is really the only sequela in the hands of a trained professional. If
the injector needs to tweak a treatment, the final result is 4 weeks from
the initial injection. It is a delicate balance here with special events. It is
common practice to begin a brides treatment plan about a year from the
date. A wedding is too essential of a day to begin practicing treatments.
The photos will be her only moments from that day, and if she had a
botched esthetic procedure, the injector would be thought of in a negative light every time that album is picked up. All of her friends and family will be told the horrific story of how the injector ruined her one
special day in her life. A bride is very stressed out and will typically have
unrealistic expectations of perfection. It is advised that the injectionist
use their judgment with regards to upcoming special events.
4. Cardiovascular disease
There have been a limited number of reports following the administration of botulinum toxin A of adverse events involving the cardiovascular
system. The reports included arrhythmia and myocardial infarction;
some cases did end with fatal outcomes. The patient reported having
issues post neuromodulation and suffered a cardiac event with previous
risk factors, including pre-existing cardiovascular disease. In expert
38 Essentials of neuromodulation
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opinion, the literature is not supportive at this time to demonstrate that
the neuromodulation caused the event. However, with the use of any
drug, it is advised that caution be used when administering the medication to patients with pre-existing cardiovascular disease. One fatal case
was reported in the absence of cardiac history post neuromodulation.
After further review, it was found that the provider reconstituted the
neuromodulator with lidocaine instead of saline or preservative saline.
This particular isolated instance of injector error was not related to the
neuromodulator.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
5. Pre-existing conditions at the injection site
Caution should be used when botulinum toxin treatment is used in the
presence of inflammation at the proposed injection site(s), ptosis, or
when excessive weakness or atrophy is present in the targeted
muscle(s). Scaring, trauma, swelling, and many underlying issues at
the injection site can lead to an adverse event.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
6. Breathing or swallowing disorders
Treatment with neuromodulators can result in swallowing or breathing
difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is
a consequence of the weakening of muscles in the injection area that is
involved in breathing or oropharyngeal muscles that control swallowing
or breathing. Deaths as a complication of severe dysphagia have been
reported after treatment with botulinum toxin. These reports of death
were not in the esthetic client. They were reported under the use of therapeutic medical treatment. Much higher doses are given in these patients,
and they also receive the neuromodulator in higher risk areas that control
pertinent muscles related to the stability of neck muscles and airway.
Dysphagia may persist for several months and require the use of a feeding
tube to maintain adequate nutrition and hydration. Aspiration may result
from severe dysphagia and is a particular risk when treating patients in
whom swallowing or respiratory function is already compromised.
Treatment with botulinum toxins may weaken neck muscles that serve as
accessory muscles of ventilation. The inadvertent injection into the
wrong area may result in a critical loss of breathing capacity in patients
with respiratory disorders who may have become dependent upon these
accessory muscles. There have been post-marketing reports of severe
breathing difficulties, including respiratory failure. When treating the
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esthetic client’s platysmas band, this is an inherent risk.
Patients with smaller neck muscle mass, and patients who require bilateral injections into the sternocleidomastoid muscle for cervical dystonia
treatment are at greater risk for dysphagia. Limiting the dose injected into
the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
Injections into the levator scapulae may be associated with an increased
risk of upper respiratory infection and dysphagia.
Patients treated with botulinum toxin may require immediate medical
attention if they develop swallowing, speech, or respiratory problems.
These reactions can occur within hours to weeks after injection with
botulinum toxin.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
7. Human albumin and transmission of viral diseases
Allergy to human albumin (it is remote with the use of all neuromodulators)*. All of the commercially available products contain albumin.
Human albumin is a derivative of human blood. Based on effective
donor screening and product manufacturing processes, neuromodulation carries an extremely remote risk of transmitting viral diseases.
A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)
is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin. Religious preference
may play an essential role in the use of neuromodulators, given that there
is a trace amount of human blood in the product.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
8. Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity.
Treatment with BoNT-A may result in the formation of neutralizing
antibodies known to reduce the effectiveness of subsequent treatments
by inactivating the toxin’s biological activity. Xeomin claims that
because they do not use any accessory proteins, users can not develop
immunogenicity. Currently, the recommendation for treating the
immune response is waiting 6 months to 1 full year without utilizing
any neuromodulation treatments. After the washout period of 6 months
to 1 year, the patient is advised to go back to their provider and initiate
treatment. Clinical trials have shown this pause therapy to effectively
clear out the system and allow neuromodulation to be effective again.
(Allergan, 2020; Dysport, 2020; Jeuveau, 2020; Xeomin, 2020)
39Safety of neuromodulators
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9. Zinc deficiency
We learned earlier that BoNT-A is a metalloprotease drug; this means
that BoNT-A’s are metal-dependent, specifically Zinc dependent. There
is a subgroup among the metalloproteases, and that is gluzincin. The
word even has Zinc right in it, alluding to the importance of Zinc in
the role of BoNT-A release of acetylcholine to disrupt the message center. There must be adequate Zinc within the host in order for the BoNTA to bind and prohibit the release of acetylcholine. Zinc deficiencies are
most prevalent in developing countries. However, in the United States,
the range of statistics is from 12% to 40% demonstrating zinc deficiencies
(Lebeda et al., 2010). Even with an adequate nutritional intake of Zinc, it
is still possible for one to be deficient. Zinc deficiency can occur due to
poor absorption of the nutrients ingested. There is heaps of relevant
information coming to light on the gut biome. After much reading, it
appears that a zinc deficiency can cause an alteration in the gut biome.
Conversely and interestingly enough, a person with an altered gut biome
will have trouble absorbing the nutrients. The concept of Zinc deficiency brings about a moment of pause and highlights the need for further research on nutrients and the gut biome.
Most developers of neuromodulators will advise that the office has an
Epi-pen on hand as well as liquid Benadryl, ice, and sniffing salts. It is at
a minimum that an esthetic practice have a basic first aid kit on hand.
The state boards will not take exception to the first aid kit during an
inspection.
There have been no systemic reaction reports and no reported long-term
complications or hazards using neuromodulation for approved esthetic purposes. Severe adverse reactions, including excessive weakness, dysphagia,
and aspiration pneumonia, with some adverse reactions associated with fatal
outcomes, have been reported in patients who received botulinum toxin
injections for unapproved uses. In these cases, the adverse reactions were
not necessarily related to the distant spread of toxin but may have resulted
from the administration of botulinum toxin to the site of injection and adjacent structures. In several of the cases, patients had pre-existing dysphagia or
other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the
unapproved uses of botulinum toxin. The safety and effectiveness of botulinum toxin for unapproved uses have not been established.
A lethal dose of botulinum toxin would be 25–35, one hundred unit
vials. Diluted that would equate to 2500–3000 units of BoNT-A. These
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studies come from reports of childhood deaths that were treated with high
dose therapy for cerebral palsy. Cosmetic procedures have a maximum
cumulative dose recommendation generally to not exceed 360 units in a
3-month interval.
Drug to drug interactions
Many patients are at the mercy of multiple doctors and, at times, can be
experiencing polypharmacy. Due diligence is required for the community’s
safety, and part of due diligence is taking a thorough medical history. Present
the form in layman’s terms so that the reader can truly understand the language. Medical terms are a different language, and health care providers can
not assume that the patient has the same level of understanding. Break it
down for the patient.
1. Avoid concurrent treatment with aminogylcosides or other agents interfering with neuromuscular transmission. It is thought that the aminoglycoside could potentiate the weakness from botulinum toxin A injections.
Examples of an aminoglycoside:
Tobramicin
Gentamicin
Paromycin
Amikacin
Neomycin
2. Anticholinergics—these are drugs that block acetylcholine.
Examples of anticholinergics:
Amitriptyline (Elavil)
Benztropine (Cogentin)
Chlorpheniramine (Actifed, Allergy & Congestion Relief, Chlor-
Trimeton, Codeprex, Efidac-24 Chlorpheniramine, etc.)
Chlorpromazine (Thorazine)
Clozapine (Clozaril)
Cyclobenzaprine (Amrix, Fexmid, Flexeril)
Dicyclomine (Bentyl)
Diphenhydramine (Advil PM, Aleve PM, Bayer PM, Benadryl, Exce-
drin PM, Nytol, Simply Sleep, Sominex, Tylenol PM, Unisom, etc.)
Doxepin (Adapin, Silenor, Sinequan)
Hydroxyzine (Atarax, Vistaril)
Meclizine (Antivert, Bonine)
Nortriptyline (Pamelor)
42 Essentials of neuromodulation
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Olanzapine (Zyprexa)
Orphenadrine (Norflex)
Oxybutynin (Ditropan, Oxytrol)
Paroxetine (Brisdelle, Paxil)
Prochlorperazine (Compazine)
Protriptyline (Vivactil)
Pseudoephedrine HCl/Triprolidine HCl (Aprodine)
Scopolamine (Transderm Scop)
Thioridazine (Mellaril)
Tolterodine (Detrol)
Anticholinergic drugs with a lesser effect:
Alprazolam (Xanax)
Amantadine (Symmetrel)
Baclofen
Carisoprodol (Soma)
Cetirizine (Zyrtec)
Cimetidine (Tagamet)
Clorazepate (Tranxene)
Codeine
Colchicine
Digoxin (Lanoxicaps, Lanoxin)
Diphenoxylate (Lomotil)
Fluphenazine (Prolixin)
Furosemide (Lasix)
Hydrochlorothiazide (Esidrix, Dyazide, HydroDIURIL, Maxzide &
literally scores of other medications for high blood pressure)
Loperamide (Imodium)
Loratadine (Alavert, Claritin)
Maprotiline
Nifedipine (Adalat, Procardia)
Ranitidine (Zantac)
Thiothixene (Navane)
Tizanidine (Zanaflex)
3. Curare like non-depolarizing blockers-muscle relaxers.
4. Lincosamides—A class of antibiotics treating Gram-positive bacteria and
Protozoans.
Examples of this drug:
Clindamycin
5. Polymyxins are antibiotics that work on gram-negative bacteria.
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43
Examples of polymixins:
Polymyxin B and polymyxin E (also known as colistin)
6. Quinidine is a class 1 antiarrhythmic drug and is used as an
antimalarial drug.
7. Magnesium sulfate—used to treat low levels of magnesium.
8. Anticholinesterases—these drugs are used in Parkinson’s and prevent
the neurotransmitter acetylcholine breakdown by the enzyme
acetylcholinesterase.
Examples of this drug are:
Physostigmine
Neostigmine
9. Succinylcholine chloride.
These drugs can potentiate the effect of the toxin.
References
Allergan. (2020). Botox Cosmetic history. https://www.botoxcosmetic.com/what-is-botox-
cosmetic/botox-cosmetic-history. (Accessed March 2020).
Cote, T. R., Mohan, A. K., Polder, J. A., Walton, M. K., & Braun, M. M. (2005). Botulinum
toxin type A injections: Adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. Journal of American Academy Dermatology, 53,
407–415. https://doi.org/10.1016/j.jaad.2005.06.011. Accessed May 2020.
Dysport. (2020). For health care professionals. https://www.dysportusa.com/healthcare-
professionals#importantsafetyinformation. (Accessed March 2020).
Jeuveau. (2020). Ready for a modern-made tox?. https://jeuveau.evolus.com. (Accessed July
2020).
Lebeda, F., Cer, R., Mudunuri, U., Stephens, R., Singh, B., & Adler, M. (2010). The zinc-
dependent protease activity of the botulinum neurotoxins. Toxins, 2(5),
979–997. https://doi.org/10.3390/toxins2050978.
Stone, H. F., Zhu, Z., Thach, T. Q. D., & Ruegg, C. L. (2011). Characterization of diffusion
and duration of action of a new botulinum toxin type A formulation. Toxicon, 58(2),
159–167. Science Direct https://doi.org/10.1016/j.toxicon.2011.05.012. Accessed
May 2020.
Xeomin. (2020). A uniquely purified choice for frown lines. https://www.xeominaesthetic.com/
professionals/. (Accessed March 2020).
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