scholarly journals Botulinum toxin type A injections: Adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases

2005 ◽  
Vol 53 (3) ◽  
pp. 407-415 ◽  
Author(s):  
Timothy R. Coté ◽  
Aparna K. Mohan ◽  
Jacquelyn A. Polder ◽  
Marc K. Walton ◽  
M. Miles Braun
2006 ◽  
Vol 21 (3) ◽  
pp. 189-193 ◽  
Author(s):  
Edward M. Goldstein

This retrospective chart review examines the safety of high-dose (≥ 15 U/kg body weight or ≥ 800 total units) botulinum toxin type A (BOTOX, Allergan Inc., Irvine, CA) in children and young adults with spasticity. Ninety-four children weighing < 45 kg received a mean total dose of 334.1 U or 19.1 U/kg. Fourteen young adults weighing ≥ 45 kg received a mean total dose of 927.3 U or 15.2 U/kg. Adverse events were reported by 3 of the 108 patients (2.8%) and included single instances of rash and enuresis. The only serious adverse event consisted of mild, generalized botulism in a 13-year-old patient who received a 23 U/kg dose to the hamstrings and gastrocnemius/soleus bilaterally. No serious adverse events were noted in children weighing < 45 kg who received botulinum toxin type A doses of 15 to 22 U/kg of body weight or in young adults ≥ 45 kg who received total doses of 800 to 1200 U in a single injection protocol. High-dose botulinum toxin type A is safe for the treatment of spasticity in children and young adults. ( J Child Neurol 2006;21:189—192;


2019 ◽  
Vol 40 (5) ◽  
pp. NP273-NP285 ◽  
Author(s):  
Xiaoshuang Guo ◽  
Guodong Song ◽  
Dong Zhang ◽  
Xiaolei Jin

Abstract Background Botulinum toxin type A-induced “chemoimmobilization” has long been utilized for improved scar quality and wound healing; however, current evidence is limited to small studies, and evidence-based information is inadequate to make well-informed decisions. Objectives The purpose of this study was to evaluate the efficacy of botulinum toxin type A (BTA) to improve scars and wound healing. Methods The authors searched databases, including Pubmed, Embase, and Cochrane Library, to identify randomized clinical trials (RCTs) that compared outcomes of surgical scars and wounds treated with BTA vs those treated with blank or placebo controls. The Visual Analog Scale, Vancouver Scar Score, scar width, and reported patient satisfaction were utilized in evaluating outcomes. Adverse events were also recorded. Results Eleven RCTs involved a total of 486 cases (374 patients). Quantitative synthesis suggested that compared with the control group, patients in the BTA treatment group had significantly higher Visual Analog Scale scores (mean difference [MD] = 1.30, 95% confidence interval [CI]: 1.05 to 1.55), lower Vancouver Scar Scores (MD = −1.62, 95% CI: −2.49 to −0.75, P = 0.0003), and thinner scars (MD = −0.15, 95% CI: −0.20 to −0.11, P &lt; 0.00001). Patient satisfaction was higher in the BTA group than in the control group (risk ratio: 1.25, 95% CI: 1.06 to 1.49, P = 0.01). Trivial adverse events were reported. Conclusions This meta-analysis of RCTs provides reliable evidence that BTA injection is superior to placebo or blank control group in improving scar quality and wound healing in the face and neck for Asians, and negative outcomes for BTA treatment in these patients include only trivial adverse events. However, inadequate evidence supports utilization of BTA in Caucasians for primary surgical scars or for scars in locations other than the face and neck. Further studies on the standardized injection regimen and technique of BTA are warranted for clinical practice. Level of Evidence: 1


2016 ◽  
Vol 40 (5) ◽  
pp. 769-777 ◽  
Author(s):  
Zhenhua Jia ◽  
Haibin Lu ◽  
Xiaonan Yang ◽  
Xiaolei Jin ◽  
Rongwei Wu ◽  
...  

2011 ◽  
Vol 53 (2) ◽  
pp. 125-130 ◽  
Author(s):  
STEPHEN J O’FLAHERTY ◽  
VYSHNAVI JANAKAN ◽  
ANGELA M MORROW ◽  
ADAM M SCHEINBERG ◽  
MARY-CLARE A WAUGH

Urology ◽  
2020 ◽  
Vol 142 ◽  
pp. 190-194 ◽  
Author(s):  
Seyedeh-Sanam Ladi-Seyedian ◽  
Lida Sharifi-Rad ◽  
Abdol-Mohammad Kajbafzadeh

US Neurology ◽  
2009 ◽  
Vol 05 (01) ◽  
pp. 38
Author(s):  
Cindy B Ivanhoe ◽  
Natasha K Eaddy-Rose ◽  
◽  

Background:Stroke is a significant contributor to morbidity and mortality in the US and other developed nations. Stroke and its side effects are the primary cause of disability in the US and worldwide. Upper limb mobility factors are particularly detrimental to activities of daily living. Successful treatments to improve post-stroke spasticity are required.Objective:To assess the relevant medical literature related to the use of botulinum toxin type A and post-stroke spasticity of the upper limb.Methods:Literature review utilizing Medline with keywords of botulinum toxin, stroke, spasticity, and upper extremity since 2003.Results:Thirteen criteria-based articles investigated botulinum toxin type and poststroke spasticity of the upper limbs. Discussion: Botulinum toxin type A is an effective agent in reducing post-stroke spasticity of the upper limbs.


Toxins ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 588
Author(s):  
Hyungkyu Bae ◽  
Jisoo Kim ◽  
Kyle K. Seo ◽  
Kyung-Seok Hu ◽  
Seong-Taek Kim ◽  
...  

The aim of the study was to propose a more efficient and safer botulinum toxin type A (BoNT-A) injection method for the masseter by comparing the conventional blind injection and a novel ultrasonography (US)-guided injection technique in a clinical trial. The 40 masseters from 20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years) were included in this prospective clinical trial. The BoNT-A (24 U) was injected into the masseter of each volunteer using the conventional blind and US-guided injection techniques on the left and right sides, respectively, and analyzed by US and three-dimensional (3D) facial scanning. One case of PMB (paradoxical masseteric bulging) was observed on the side where a conventional blind injection was performed, which disappeared after the compensational injection. The reduction in the thickness of the masseter in the resting state differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 12.38 ± 7.59% and 17.98 ± 9.65%, respectively (t(19) = 3.059, p = 0.007). The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively (t(19) = 2.908, p = 0.009). The results of the study showed that the US-guided injection method that considers the deep inferior tendon by visualizing the masseter can prevent the PMB that can occur during a blind injection, and is also more effective.


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