Long-term safety and efficacy data on botulinum toxin type A: an injection for sialorrhea.

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.