Long-term Safety and Efficacy Data on Botulinum Toxin Type A

Abstract

Objective: To evaluate the safety and efficacy data on salivary gland injection botulinum toxin type A for the treatment of sialorrhea. Design and Setting:Retrospective cohort study in a tertiary academic children's hospital. Patients:A 10-year review ( January 1, 2001, through December 31, 2010) of 69 children with sialorrhea who had undergone salivary gland injection of botulinum toxin type A.Interventions: Injection of botulinum toxin type A to the submandibular and parotid glands.Main Outcome Measures: Postinjection complications, supplemental treatments, and caregiver satisfaction.Results: A total of 69 children were included in the study (42 boys and 27 girls). The first injection was given at a mean age of 9.9 years with a mean follow-up of 3.1 years. Children underwent ultrasonography-guided 4-gland injection at a constant dosage range. The telephone survey response rate was 51%. Postinjection complications occurred in 19 patients (23 events)-14 (15 events) with minor and 5 (8 events) with major complications. Major complications included aspiration pneumonia (n=3), severe dysphagia (n=2), and loss of motor control of the head (n=3), resulting in 5 hospitalizations and 2 nasogastric tube insertions. Complications were not associated with demographic or clinical factors except for a male preponderance (P =.05). Satisfaction scores were evenly distributed among respondents. Thirty-one children (45%) required supplemental treatments: medical treatment alone (n=21), surgical treatment alone (n=2), and combined medical and surgical treatment (n=8).Conclusions: Although our complication rate is within the published range, some of the major complications had significant morbidity. A subsequent surgical rate of 15% suggests the efficacy is less than universal. Thus, botulinum toxin type A injection for sialorrhea in children is a useful tool but has safety and efficacy limitations.

Safety of Ultrasound‐Guided Botulinum Toxin Injections for Sialorrhea as Performed by Pediatric Otolaryngologists

“…11 The other published review references unpublished data of no complications in 1200 children receiving ultrasound-guided Botox injections to the salivary glands. 11 There were several limitations noted throughout this study. The majority of this patient population was found to be medically fragile, with histories of dysphagia and aspiration pneumonia.…”

Effect of recurrent onabotulinum toxin a injection into the salivary glands: An ultrasound measurement

“…The therapeutic use of OBTXA for excessive drooling is now well accepted and rapidly growing, although the complication rates and long‐term safety are still not well known or described . The common side effects of OBTXA injections are usually minor and temporary, including local hematoma, pain, and erythema (0% to 18.7%); mild dysphagia, viscous saliva, and dry mouth .…”

“…14 The therapeutic use of OBTXA for excessive drooling is now well accepted and rapidly growing, although the complication rates and long-term safety are still not well known or described. 15 The common side effects of OBTXA injections are usually minor and temporary, including local hematoma, pain, and erythema (0% to 18.7%); mild dysphagia, viscous saliva, and dry mouth. 16 In rare cases (0% to 7.7%) major complications can occur such as aspiration pneumonia, loss of motor control of the head, severe dysphagia sometimes requiring placement of a nasogastric tube, 15 and local injuries of the facial nerve branches and the carotid arteries.…”

The use of botulinum toxin B in the treatment of a post-traumatic sialocele in a 4-year-old child: A case report

“…Botulinum toxin has previously been described in the management of sialorrhea in children with neuromuscular disorders [3][4][5] . Injection into the submandibular and parotid glands is effective in achieving salivary control, although this effect is temporary with an average duration of 4 months 5 .…”