Adverse Reactions

Former Clinical Assistant Professor, University of California, Irvine, CA, USA



BotoxDysportXeominNeurotoxin complicationsBotulinumtoxin type AEyelid ptosisBrow ptosisAesthetic techniqueAesthetic nursingContraindicationsLip asymmetry

15.1 Contraindications and Adverse Effects Related to BoNT/A

Botulinumtoxin type A is one of the most widely studied drugs in the world and although the safety and efficacy studies are positive, there are a few potential adverse effects but no reported deaths when used cosmetically (Dayan 2013). Absolute contraindications to BoNT/A treatment are few but include allergy to any of the components of the medication or pre-existing infection at the injection site. Further, BoNT/A prescribing instructions include avoidance of injection into patients with a history of neurological conditions or diseases. There is also an extremely remote potential of spread of viral illness or Creutzfeldt–Jakob disease although there has not ever been a reported case of either (Carruthers and Carruthers 2005; Allergan 2017).

BoNT/A treatment is contraindicated in pregnant or lactating women, or women who are planning to become pregnant because there is scant literature on the safety of administration during these times. In animal studies, there are increased risks of toxicity (Allergan 2017; Ipsen 2017; Merz 2018; Pirazzini et al. 2017). However, it has been found that administration of BoNT/A during or before the first trimester of pregnancy, the outcomes are identical to the general population outcome (Brin et al. 2016).

The following are the most commonly reported adverse reactions from BoNT/A cosmetic treatment:

  • AbobotulinumtoxinA (Dysport ®)

    Glabellar Lines: (≥2%) nasopharyngitis, headache, injection site pain or reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis, nausea, and blood present in urine (Ipsen 2017).

  • OnabotulinumtoxinA (Botox ®)

    Glabellar Lines: eyelid ptosis (3%)

    Lateral Canthal Lines: eyelid edema (1%)

    Forehead Lines: headache (9%) and brow ptosis (2%) (Allergan 2017)

  • IncobotulinumtoxinA (Xeomin ®)

    Glabellar Lines: (>1% of patients) headache (Merz 2018)

15.2 Adverse Effect Related to the Penetration of Skin by the Needle

As with any injection, there may be pain at the injection site due to penetration of the needle through the skin and subsequent stimulation of nerve endings. This pain may be decreased by the application of ice or topical anesthetic to the area at least 30 min prior to treatment, although many patients tolerate the procedure without anesthetic. Other potential ways to decrease the pain associated with BoNT/A treatment are use of smaller gauge needle, vibration injection technique, and/or use 0.9% sodium chloride solution with preservative as the diluent (Sharma et al. 2011). There is no evidence that preservative-free diluent or 32G needles are associated with better outcomes (Carruthers and Carruthers 2005; Price et al. 2010).

Another adverse effect related to the penetration of skin by the needle is the potential for infection. Although it has been demonstrated through large studies that 70% isopropyl alcohol antisepsis does not decrease rates of infection, it may offer some protection against the extremely remote local infection rate (Pham and Perry 2009). However, BoNT/A treatment is contraindicated in the presence of infection at the treatment site to avoid introduction of pathogens into deeper tissue via needle puncture (Allergan 2017; Ipsen 2017; Merz 2018). In addition, best practice recommends the practitioner’s hands be clean, gloved, and free from pathogens.

An additional adverse effect is bruising related to needle puncture. At any time a needle is inserted into the skin, there is a possibility it will graze or puncture a vessel. When the vessel opens, blood spills out into the surrounding tissue, with bruising commensurate with amount of blood leakage. Even a small drop of blood can leave a noticeable bruise. Some suggestions for patients to decrease the potential or amount of bruising are to avoid drinking alcohol, taking non-essential anticoagulants such as aspirin (unless medically indicated), non-steroidal anti-inflammatory drugs (NSAIDs), and herbal remedies such as garlic, ginger, vitamin E, fish oil, St. John’s wort, among others, for 7–10 days prior to treatment (Carruthers and Carruthers 2005; Emer and Waldorf 2011).

Another option to help reduce the incidence of bruising a patient during treatment is the use of a near infra-red (NIR) vessel locator, i.e., Accuvein®. The NIR device displays a map of the superficial vessels of the skin so the practitioner can avoid puncture of a vein by a needle during aesthetic injection procedures. A device to assist practitioners in vein visualization can improve patient satisfaction and safety by helping to prevent bruising (see Fig. 15.1).


Fig. 15.1

The near infra-red (NIR) light illuminates vessels under the skin and can help prevent bruising. Photo: B. Haney, DNP, FNP-C, FAANP

Local swelling at the injection site is usually temporary, lasting 20–30 min. The solution of the neurotoxin is injected as a depot into spaces in the face where the tissue is thin and difficult to camouflage so the solution is visible in the local area until it dissipates. This can be alarming for treatment-naive patients because the sites resemble insect bites immediately after injection. On occasion, an injection site may remain edematous for days or weeks if a deep vessel was injured and the blood remains contained under the superficial tissues causing a subcutaneous hematoma.

15.3 Adverse Effect Related to Technique

Patient expectations will determine the level of satisfaction so expectations should be very clear before BoNT/A treatment. Management of patient expectations is an important aspect of any cosmetic procedure and should be thoroughly discussed and documented in the patient record. Undesired muscle impairment, ptosis of the eyelid(s), ptosis of the brow, asymmetry of brows or smile, plateau smile (orbital area), and decreased efficacy are all adverse effects related to technique and/or local diffusion of the BoNT/A into surrounding muscle fibers (Carruthers and Carruthers 2005; Allergan 2017; Ipsen 2017; Merz 2018).

15.3.1 Undesired Muscle Impairment

A common complaint from women is the formation of superficial upper lip lines or smoker’s lines. These superficial lip lines are caused by smoking, sun exposure, or volume loss. Many of these women deny ever smoking and are distraught at the appearance of these lines. But smoking is not the only cause for these lines and explanation of the role of sun exposure, volume loss, and/or muscle contraction should be reviewed with the patient. A low dose of BoNT/A into the fibers of the orbicularis oris has been found to be helpful in temporarily alleviating the appearance of upper and lower lip lines. However, if too large a dose is used, lip dysfunction is imminent and results from diffusion of too much neurotoxin into the orbicularis oris muscle fibers.

The patient may notice asymmetrical smiling, difficulty pronouncing certain words, inability to whistle or play musical instruments, or impaired drinking and eating (Carruthers and Carruthers 2003, 2005). The patient who cannot tolerate these potential side effects, especially speakers, singers, and musicians, should be counseled about different options to treat lip lines such as laser resurfacing or dermal fillers/smoothers. Typical dosing for the treatment of fine lines around the mouth ranges from 4 units of onabotulinumtoxinA, prabotulinumtoxinA-xvfs, and incobotulinumtoxinA or 10 units of abobotulinumtoxinA up to 12 units of the former or 30 units, respectively, divided between 4 and 8 injection sites (Carruthers and Carruthers 2003, 2004). Since a lower BoNT/A dose is used around the mouth compared to the upper face, the effect does not last as long, typically about 6–8 weeks and this is another consideration to review with patients.

15.3.2 Eyelid Ptosis

Eyelid ptosis is a potential side effect of BoNT/A treatment (Allergan 2017; Ipsen 2017; Merz 2018). Eyelid ptosis gives the patient a heavy lid sensation and a sleepy appearance that can last for days or weeks. This unfavorable side effect is caused from diffusion of the BoNT/A into the levator palpebrae superioris, and can be avoided by using precise technique (Carruthers and Carruthers 2006; Lorenc et al. 2013). This side effect is easily avoided by accurate placement of the BoNT/A no closer than 1 cm above the bony orbital rim and avoiding injecting beyond the mid-pupillary line when injecting the glabella area (Carruthers and Carruthers 2005; Lorenc et al. 2013). The application of pressure under the orbital bone during injection of the corrugators may help prevent ptosis.

If eyelid ptosis occurs, it can be treated with apraclonidine drops if desired (Wijemanne et al. 2017). Apraclonidine is a prescription eye drop that helps to elevate the upper eyelid through stimulation of an adrenergic muscle located near the levator muscle called Muller’s muscle (Carruthers and Carruthers 2005; Wijemanne et al. 2017). These drops can be used as directed until the ptosis resolves, usually within several weeks or earlier.

15.3.3 Brow Ptosis

Brow ptosis results from too high a dose in the frontalis or injection sites placed too low and may last for the duration of treatment, 3–4 months. The patient may complain of heavy, flattened, dropped brows and a completely immobile forehead. On occasion, they can also experience puffiness to the eyelids. The practitioner can avoid brow ptosis by injecting the procerus and corrugator muscles along with the frontalis to ensure the counter balance of depressor and elevator muscles (see Chap. 2) (Carruthers and Carruthers 2006, 2007; Lorenc et al. 2013). In addition, injecting a small amount 1 cm above the orbital rim at the mid-pupillary line will help prevent brow and lid ptosis (Carruthers and Carruthers 2005; Kordestani et al. 2016). Further, a technique can be used where a low dose of BoNT/A is injected at the lateral tail of the brow and procerus along with the frontalis; this can also help prevent brow ptosis. It is not recommended to treat the frontalis exclusively (Carruthers and Carruthers 2005, 2007, 2006; Lorenc et al. 2013).

15.3.4 Plateau Smile

A patient may complain of a shelf or dent when they smile several days or weeks after BoNT/A treatment for crow’s feet. This happens because the injection sites were positioned too close to the lateral canthus and there is subsequent relaxation of the orbital muscles, while the remaining facial muscles continue to have full movement (Carruthers and Carruthers 2005). This results in an unbalanced look where the face moves normally when smiling but the eyes are motionless causing the cheek to create a crease commonly called plateau smile. One way to avoid this is to inject at least 1cm away from the lateral canthus and in some cases, avoid the lowest injection site altogether (Carruthers and Carruthers 2005, 2006).

15.3.5 Medication Tolerance

A potential additional adverse effect is decreased length of effect from the BoNT/A medication on the treated muscles. Dose related concerns include shorter duration of effect but some patients have short duration of effect even when recommended doses have been administered. One theory is the muscle fibers that are undertreated with low doses do not have enough saturation of the toxin and therefore the result of treatment duration is shorter and/or weaker (Klein 2003; Carruthers et al. 2005). There is a potential increased risk of shorter treatment duration when patients are chronically under-dosed, that is, patients who repeatedly return before the recommended 3-month interval or who consistently receive lower than recommended doses (Frevert 2015; Carruthers et al. 2005). To ensure the best outcome, appropriate dosing is essential and frequent touchups should be avoided (Naumann et al. 2013).

15.3.6 Patient Dissatisfaction

Lastly, patient dissatisfaction can also be considered an adverse effect. Patients may not receive the outcome they expected and can be disappointed. Bruising, swelling, heavy lids, and unnatural shaped brows can result from treatment and should be discussed in the consultation (see Fig. 15.2) (Alam et al. 2002). Reassurance that with time or a slight adjustment using additional BoNT/A can help alleviate these effects.


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Apr 18, 2020 | Posted by in NURSING | Comments Off on Adverse Reactions

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