Serious adverse events related to the cosmetic use of botulinum toxin include thyroid eye disease in a patient with Graves hyperthyroidism, sarcoidal granuloma, pseudoaneurysm of the frontal branch of the superior temporal artery, and severe respiratory failure. eCollection 2020. Initial treatment increases your survival chances and lowers your risk of complications. Field M, Splevins A, Picaut P, et al. There are no reports of teratogenic effects in humans from in utero botulinum toxin exposure. eCollection 2020 Apr-Jun. The patient should shower and be decontaminated immediately. https://www.uptodate.com/contents/search. Varghese-Kroll E, Elovic EP. Commercial heat pasteurization (including vacuum packed pasteurized products and hot smoked products) may not be sufficient to kill all spores and therefore the safety of these products must be based on preventing bacterial growth and toxin production. Treatment with botulinum toxin is widely viewed as safe, effective and largely devoid of serious side effects. The majority of anti-toxin antibodies do not affect its function. According to Kothari et al., diplopia occurs in 2.1% of patients [12]. In addition to injection site complications, there is a group of aesthetic and functional adverse effects associated with different muscle responses to botulinum toxin or with the misplacement of botulinum toxin. There are some well-known, mild side effects of botulinum toxin treatment on the upper face. Some researchers report that up to 1% of patients who receive botulinum toxin injections may experience severe, debilitating headaches [6]. Higher zygomas and less prominent cheek fat pads predispose to sunken lateral cheeks. To prevent infection, the injection site should be cleaned with an antiseptic solution with all makeup residue removed. Direct digital pressure can be used to isolate the injection site from the eye. Foodborne botulism, caused by consumption of improperly processed food, is a rare but potentially fatal disease if not diagnosed rapidly and treated with antitoxin. In the older patient, a combination of loose skin and attenuated orbital septum can further facilitate the dissection of injected botulinum toxin. BTX-A effectively alleviated patients with TN in both short or long term, although the treatment efficacy may depend on patient characteristics. To manage infections, a course of antibiotics and close monitoring of the area is essential to ensure that an abscess does not form, which could potentially result in a scar. C. botulinum is an anaerobic bacterium, meaning it can only grow in the absence of oxygen. Homemade canned, preserved or fermented foodstuffs are a common source of foodborne botulism and their preparation requires extra caution. In accordance with this, such patients should be undertreated and the physicians strategy for a balanced botulinum toxin treatment should be shared with the patient. In the treatment or prevention of the Mephisto sign we can use an additional dose of botulinum toxin to paralyze lateral fibers of the frontalis muscle [19]. Muscle Nerve. doi: 10.1586/14737175.7.11.1565. Headaches can occur with facial injections. Or the wound may be caused by a traumatic injury or surgery. 1 As such, staying abreast of the latest research and discoveries, understanding the clinical science and pharmacodynamics, and being aware of the myths and misconceptions in BoNT-A use are vital for all practitioners. Adverse events after botulinum A toxin injection for neurogenic voiding disorders. Vitreous hemorrhage and Rhegmatogenous retinal detachment that developed after botulinum toxin injection to the extraocular muscle: case report. Altered anatomy as a result of previous plastic facial surgery predisposes to more severe botulinum toxin-related side effects. official website and that any information you provide is encrypted Raw (unpasteurized) milk and cheese = Listeria monocytogenes. In rare cases, botulism can also be caused by medical treatment or bioterrorism. Guidelines on the use of botulinum toxin type A. Vartanian AJ, Dayan SH. Hypoesthesia may also be related to the localized antinociceptive properties of botulinum toxin, which has been suggested by preliminary in vivo and in vitro data [6]. Dressler D. Five-year experience with incobotulinumtoxin A (Xeomin(. Centers for Disease Control and Prevention. Cosmetic treatment of cervical wrinkles and lines usually requires larger doses of botulinum toxin and increases the risk of serious side effects. A total of 136 patients exhibited symptom improvement within 2 weeks following BTX-A treatment as evaluated using a visual analog scale (VAS). Human botulism may refer to foodborne botulism, infant botulism, wound botulism, and inhalation botulism or other types of intoxication. Botulinum toxin is widely used in facial rhytide treatments. van Hulst K, Kouwenberg CV, Jongerius PH, et al. These cases are comparable to infant botulism and may occur when the normal gut flora has been altered as a result of surgical procedures or antibiotic therapy. If you think a wound is infected, seek medical treatment right away. The US Food and Drug Administration (FDA) describes adverse effects as serious if they meet the strict criteria. Sesardic D, Jones RG, Leung T, Alsop T, Tierney R. Mov Disord. Patients with diseases of the neuromuscular junction, such as myasthenia gravis, multiple sclerosis and Lambert-Eaton syndrome, are particularly susceptible to the adverse events of botulinum toxin. Bloom BS, Payongayong L, Mourin A, et al. Accessed April 16, 2022. Diffusion of botulinum toxin to contralateral muscles has also been reported. government site. Keywords: botulism, botulinum neurotoxin, spasticity, spinal cord injury. Contralateral weakness and fatigue after high-dose botulinum toxin injection for management of poststroke spasticity. Botulinum toxins are ingested through improperly processed food in which the bacteria or the spores survive, then grow and produce the toxins. The .gov means its official. Ann Neurol. Negative effects of submandibular botulinum neurotoxin A injections on oral motor function in children with drooling due to central nervous system disorders. According to Bai et al., botulism can be classified into mild botulism with developing dizziness, headache, fatigue, blepharoptosis, and/or blurred vision, not affecting normal life; moderate botulism that additionally manifests dysphagia and/or bucking, and nasal feeding is adopted accordingly; and severe botulism, when apart from all of the aforementioned symptoms, respiratory failure appears and mechanical ventilation is applied [26]. To provide further information on factors influencing the treatment outcomes of BTX-A, a retrospective study with 152 patients with TN treated with BTX-A was performed. Xie S, Wang K, Xu T, et al. 1 INTRODUCTION. Female sex, short disease course and high injection dose (>70 units) were associated with lower long-term VAS scores. In perioral treatments, only the smallest doses are needed. Potential risk factors for diplopia are inherent susceptibility, proximity of the needle tip to the trochlea, deep penetration of the needle into the orbital septum and increased diffusion of the drug following repeated injections [12]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). This presents a significant challenge when protein-based biological therapies, such as botulinum toxin, are administered to patients. These reactions consist of a wide spectrum of symptoms, ranging from edema, erythema or redness limited to the site of injection, through diffuse erythema and generalized urticaria to anaphylactic shock [8]. Moreover, the median lethal dose of botulinum toxin used at present to estimate safety in humans is a measure only of acute drug lethality and does not reflect acute or chronic drug toxicity, for example, to the brain or other organs, which can occur at lower doses or with chronic drug administration. Factors affecting the therapeutic effect of botulinum toxin A on trigeminal neuralgia: A follow-up retrospective study of 152 patients Exp Ther Med. At present, there are three BoNT-A products available worldwide: abobotulinumtoxinA (Dysport), onabotulinumtoxinA (Botox), and incobotulinumtoxinA (Xeomin) [2]. Another unexpected change in eyebrow morphology is the Mephisto sign. Another injection site complication is localized pain, which is associated with the needle puncturing the skin. Botulism is a rare but serious condition caused by a toxin that attacks the body's nerves. Though mainly a foodborne intoxication, human botulism can also be caused by intestinal infection with, Infant botulism occurs mostly in infants under 6 months of age. It is an intoxication usually caused by ingestion of potent neurotoxins, the botulinum toxins, formed in contaminated foods. VAS, visual analog scale; L, low; M, medium; H, high. Extrinsic factors also must be considered, such as the presence of adjuvants in the formulation, either intended or unintended; increasing amounts of antigen within specific dosing ranges; frequent dosing; and, finally, the genetic predisposition of the patient. Trivalent vaccine against botulinum toxin serotypes A, B, and E that can be administered by the mucosal route. Successful treatment depends significantly on early diagnosis and the rapid administration of the botulinum antitoxin. Keywords: Accessed April 24, 2022. reported a few rare complications, such as smile limitation, paradoxical bulging, sunken cheeks, and sagging after treatment of masseter muscle prominence or hypertrophy with botulinum toxin. Different from foodborne botulism caused by ingestion of pre-formed toxins in food, it occurs when infants ingest C. botulinum spores, which germinate into bacteria that colonize in the gut and release toxins. Treatment. This condition occurs when the lateral fibers of the frontalis muscles are not sufficiently paralyzed compared to the medial fibers. Mild and transient cervical discomfort usually occurs 2 to 5 days after injection. Before They are associated with systemic and generalized botulinum toxin diffusion. Before Repeated injections may eventually enhance the pathological innervation, leading to tolerance and even exacerbation of local symptoms. https://nchfp.uga.edu/publications/publications_usda.html. Patients may suffer psychological issues due to an unattractive look [ 1 ]. In 2005, the FDA reported 36 adverse effects related to cosmetic use, which met the FDAs definition of serious adverse events, with the majority concerning dysphagia [6]. Cyclosporine can induce muscle weakness secondary to neuromuscular blockade, and can lead to respiratory failure. They include onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport) and others. To prevent the accumulation of botulinum toxin on failure of the treatment, a certain interval between successive injections is to be respected. Please enable it to take advantage of the complete set of features! Other periorbital complications are pseudoherniation of infraorbital fat pads, lagophthalmos and dry eye. There are two classes of adverse events reported so far transient and benign events, and potentially serious events [16]. 2, 3 Its action involves the selective paralysis of . Botulinum toxins are among the most toxic poisons, with a wide spectrum of both therapeutic and cosmetic indications for use. Hristova AH, Joseph LN, Sathe SA, et al. Dilution of botulinum toxin and the number of muscles injected are considered to be important factors for avoiding serious adverse effects. On the other hand, immunoresistance in the cosmetic use of botulinum toxin results in a higher risk of dose-dependent serious side effects. This raises the possibility that botulinum toxin is transported retrogradely, similarly to tetanus toxin, and may cause centrally mediated side effects. Formation of antibodies is estimated at less than 1% [7]. There were no statistically significant differences in mean pretreatment deviation (botulinum toxin, 38.8Delta; surgery, 38.2Delta) or mean follow-up (botulinum toxin, 22.6 months; surgery, 20.7). botulinum toxin; long-term outcome; sex differences; trigeminal neuralgia. sharing sensitive information, make sure youre on a federal 2022;100(5-6):314-320. doi: 10.1159/000526053. The most common complication in the treatment of the glabellar complex is ptosis of the upper eyelid known as blepharoptosis. Side effects of the use of botulinum toxin for treatment of benign essential blepharospasm and hemifacial spasm. Based on the stratified analysis, female patients with a median disease course (1-10 years) exhibited a higher incidence of side effects and male patients achieved better treatment outcomes with high BTX-A doses. Some reports indicate that antibotulinum toxin A antibodies can occur in 5% to 10% of patients who receive repeated, long-term, high-dose botulinum toxin treatments. Botulinum toxins are neurotoxic and therefore affect the nervous system. It seems to be important to gain appropriate knowledge about all possible adverse effects, their mechanisms and ways of preventing them. See this image and copyright information in PMC. The median lethal dose for humans has been estimated at 2 nanograms of botulinum toxin per kilogram of bodyweight, which is approximately 3 times greater than in foodborne cases. Botulinum toxin A (BTX-A) is a promising therapeutic modality against trigeminal neuralgia (TN) with certain controversies pertaining to its application. Eye patching or the application of a Fresnel membrane prism to eyeglasses can allay the diplopia until recovery [6]. This site needs JavaScript to work properly. Many of the muscles in the lower central face, especially those used in facial expressions, are also involved in the functions of the mouth and cheeks. Ecchymosis or bruising often results from injuring a blood vessel at the site of the injection and most commonly occurs around the ocular area. Patients with a negative skin test should receive 10 000 IU of antitoxin serum via intramuscular injection once every 12 h; patients with a positive or weak positive skin test should receive 10 000 IU via desensitization injection once a day [26]. It was reported that incobotulinumtoxinA (Xeomin) is characterized by reduced antigenicity [30]. It is mostly associated with inferior oblique paresis or rarely with lateral rectus paresis [12]. Cases have been reported in which the botulinum toxin was improperly injected into the vitreous cavity of a patient receiving treatment to the right medial rectus, resulting in increased intraocular pressure, decreased visual acuity and retinal detachment [18]. Kang SM, Feneran A, Kim JK, et al. Botulinum Toxin Type A for refractory trigeminal neuralgia in older patients: a better therapeutic effect. There are a few potentially important factors for the prevention of side effects after botulinum toxin use. The mechanism by which botulinum toxin injections cause visual symptoms is most likely due to the toxins acetylcholine (Ach) blocking effects on parasympathetic nerve terminals in the visual system acquired by means of systemic spread. These may include headache, facial paralysis, and muscle weakness. As a library, NLM provides access to scientific literature. In addition to the mechanism of generalized diffusion, another source of severe side effects is anaphylactic shock. Apart from periorbital complications, other aesthetic side effects associated with botulinum toxin injection for forehead horizontal lines are the exaggeration of wrinkles, brow ptosis, Mephisto sign, and periorbital edema. HHS Vulnerability Disclosure, Help Thorough knowledge of the anatomy of the muscles being treated is imperative to avoid serious adverse events, especially those resulting from generalized diffusion. Other complications, which may need rehabilitation, may include: Use proper techniques when canning or preserving foods at home to make sure botulism germs are destroyed. Blepharoptosis is also the most common side effect of treating strabismus with botulinum toxin injections in children [11]. official website and that any information you provide is encrypted The frequency of serious side effects is 33 times higher for therapeutic than for cosmetic cases. Pressure-cook home-canned foods at 250 degrees Fahrenheit (121 Celsius) for 20 to 100 minutes, depending on the food. Olesen J, Steiner TJ. The https:// ensures that you are connecting to the Disclaimer. The prominence of pseudoherniating infraorbital fat pads can occur following botulinum toxin treatments of the inferior eyelid in patients who have existing fat herniation. Risk assessment: WHO response is based on a risk assessment methodology that includes consideration of whether the outbreak is natural, accidental, or, possibly, intentional. 2021 Mar 8;11:602417. doi: 10.3389/fphar.2020.602417. Many factors combine to influence the likelihood and the magnitude of an immune response if a response is elicited. Some research has excluded the possible role of mutations affecting either binding or substrate cleavage of botulinum toxin in the mechanisms of primary resistance to botulinum toxin [31]. Moreover, experimental studies have shown that botulinum toxin receptors exist in the central nervous system and a small amount of botulinum toxin crosses the blood-brain barrier. Botulism of undetermined origin usually involves adult cases where no food or wound source can be identified. Those factors intrinsic to antigens that heighten their immunogenicity include nonhuman origin, larger molecules, and aggregated forms of the protein. In most adults and children older than about 6 months, this would not happen because natural defences in intestines that develop over time prevent germination and growth of the bacterium. The most significant complications of treatment of the frontalis are brow ptosis and undesired eyebrow shape. Production of polyclonal antibodies in mice against cobratoxin, botulinum toxin and ricin without altering their toxicity or use of adjuvant. Karbassi E, Nakhaee N, Zamanian M. The efficacy and complications of a new technique of Abobotulinum-toxin A (Dysport) injection in patients with glabellar lines. They are classified as a life-threatening experience requiring intervention to prevent permanent damage and associated with patient hospitalization or prolongation of existing hospitalization, and persistent or significant disability [22]. The mechanism responsible for the generalized diffusion of botulinum toxin is not known. The authors declare no conflict of interest. Intrinsic factors include the genetic, physiological, and pathological characteristics of an individual; in other words, these are traits that are "intrinsic" to a person rather than being determined by that person's environment. They often result from overaggressive treatment with injections being administered too low on the forehead, or from poor patient selection. Topical lubricating drops, lid taping, and ocular moisture chambers may be helpful in the immediate period. Contralateral weakness following botulinum toxin for poststroke spasticity. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2021; doi:10.15585/mmwr.rr7002a1. Expert Rev Neurother. Pharmacokinetics of botulinum toxin may be different in different organs [27]. Botulinum toxin serotype A (BoNT/A) is produced by the Clostridium botulinum bacterium. The needle should always point away from the orbit to avoid penetrating the septum, which serves as a diffusion barrier [32]. The lack of sensitivity to botulinum toxin can be attributed to a number of reasons, from inappropriate diagnosis to inappropriate target muscle selection or injection, or from the use of an amount of botulinum toxin insufficient to elicit the desired pharmacological outcome to the presence of antitoxin-neutralizing antibodies. These complications are technique-dependent, because they are usually due to misplacement of the toxin or to different muscle reactivity. Benign side effects are well-localized, reversible and self-limited complications which develop within a few days of the injection, and they usually disappear without any treatment. There are a few possible botulinum toxin-drug interactions which can modify the final effect of injections and trigger unexpected complications. Clinical analysis of 86 botulism cases caused by cosmetic injection of botulinum toxin (BoNT). In the UK, the cost of botulinum toxin injections can vary from about 100 to 350 for each treatment, depending on the clinic and . eCollection 2022 Jul. For example, botulism doesn't usually raise blood pressure or heart rate or cause fever or confusion. On rare occasions, a localized injection site side effect may manifest as an injection trauma. All forms of botulism can be fatal and are considered medical emergencies. The International classification of headache disorders, 2nd edn (ICDH-II) J Neurol Neurosurg Psychiatry. Its frequency is estimated at 15% [1]. Symptoms of foodborne botulism typically begin 12 to 36 hours after the toxin gets into your body. doi: 10.1002/ana.410270114. The injection of botulinum neurotoxin type A (BoNT-A) has a myriad of clinical indications and is one of the most common procedures in aesthetics. . Immunoresistance is another entity that has been clinically described in selected patients, especially those injected with large doses in multiple treatment sessions [4]. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. Adv Ther. official website and that any information you provide is encrypted Omprakash HM, Rajendran SC. Managing this with simple tamponade at the time of the bleeding can decrease the size of the bruise formed or even prevent it from appearing. This presents a significant challenge when protein-based biological therapies, such as botulinum toxin, are administered to patients. These complications can be corrected with a botulinum toxin injection into muscles that antagonize the affected muscles; however, complications caused by the involvement of adjacent muscles are temporary and will spontaneously resolve as the botulinum toxin effects diminish. These are key factors in successful . Though spores of C. botulinum are heat-resistant, the toxin produced by bacteria growing out of the spores under anaerobic conditions is destroyed by boiling (for example, at internal temperature greater than 85 C for 5 minutes or longer). Paresthesia or dysesthesia in the treatment area is rare, and may be caused by nerve trauma [8]. Botulinum toxin A treatment in facial palsy synkinesis: a systematic review and meta-analysis. May 2, 2022. There are multiple serotypes of botulinum toxins A-G varying with the molecular size, biosynthesis and cell mechanisms. Bethesda, MD 20894, Web Policies When C. botulinum bacteria get into a wound, they can multiply and make toxin. Dysphagia and muscle weakness are common symptoms of botulism. Mild bruising affects 11% to 25% of patients [6]. Botulinum Toxin as an Effective Treatment for Trigeminal Neuralgia in Surgical Practices. Underdosage is always recommendable. Principles of home canning. Intradermal injection of botulinum toxin: a safer treatment modality for forehead wrinkles. Botulinum toxins block nerve functions and can lead to respiratory and muscular paralysis. The starting time and duration of the therapeutic effect, as well as side effects, of BTX-A in the treatment of TN were analyzed by sex, age, course of disease, number of branches and injected dose. WHO also provides scientific assessments as basis for international food safety standards, guidelines and recommendations developed by the Codex Alimentarius Commission. This may involve injected muscles as well as adjacent muscles, or it may manifest as generalized muscle weakness. Bethesda, MD 20894, Web Policies Rao AK, et al. -, Devor M, Amir R, Rappaport ZH. Psoriatic skin contains more nerve fibers, and has increased levels of sensory nerve-derived calcitonin gene-related peptide (CGRP) and substance P (SP). A useful guideline for reducing blepharoptosis is to place corrugator injections at least 1 cm above the level of the supraorbital ridge [5]. In any state where neuromuscular transmission is compromised, botulinum toxin injections may potentially worsen symptoms of the existing disease state [6]. Botox treatments employ the purified and heavily diluted botulinum neurotoxin type A. Suggested and safe techniques include having the needle bevel up and injecting slowly [7]. Bai L, Peng X, Liu Y, et al. eCollection 2019. Periorbital botulinum toxin injection can cause mydriasis of the pupil, resulting in acute angle closure attack. the contents by NLM or the National Institutes of Health. Injections with botulinum toxin are effective for many clinical disorders that involve involuntary muscle activity or increased muscle tone. Prevention of foodborne botulism is based on good practice in food preparation particularly during heating/sterilization and hygiene. Dry eyes and superficial punctate keratitis: a complication of treatment of glabelar dynamic rhytides with botulinum exotoxin A. Lee DH, Han J, Han SH, et al. Long-term treatment effect of botulinum toxin A on trigeminal neuralgia represented by VAS, MeSH As the individual reaction is not always predictable, a cautious approach with rather low dosages is advisable when treating a patient for the first time. The factors that contribute to antibody formation include longer duration of treatment, a shorter time interval between injections, larger overall doses, and decreased purity of botulinum toxin preparation [6]. On the other hand, injections with botulinum toxin may be responsible for more severe side-effects.
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