• Catherine C Turkel, Beta Bowen, Jingyu Liu, and Mitchell F Brin.
• Clinical Development, Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA. Turkel_Catherine@Allergan.com
• Arch Phys Med Rehabil. 2006 Jun 1; 87 (6): 786-92.

ObjectiveTo examine the safety of botulinum toxin type A (BTX-A).DesignAnalysis of pooled data of 9 double-blind, placebo-controlled studies of patients with spasticity after stroke.SettingUniversity hospitals and specialty rehabilitation centers in the United States.ParticipantsA total of 482 patients with upper-limb spasticity and 310 with lower-limb spasticity (overall mean age, 58y; 60% men).InterventionTreatment with BTX-A (n=534; 1-3 treatments; mean dose, 231U) or placebo (n=258).Main Outcome MeasureAdverse events.ResultsMost patients (69%) received only 1 treatment with BTX-A. Patients were followed for a mean of 17.8 weeks (range, 0.1-44.7wk) after each treatment. A total of 352 (65.9%) patients in the BTX-A group and 163 (63.2%) in the placebo group reported at least 1 adverse event (P=.475). The most frequent adverse events reported by patients (>5% but <10% in either group) were respiratory infection, seizures, incoordination, and injection site pain, none of which occurred at a significantly higher rate in the BTX-A group (all P>.05). The majority of adverse events were rated as mild or moderate in severity. Only nausea was reported at a significantly higher rate in the BTX-A group (12/534 [2.2%]) than the placebo group (0/258) (P=.011); in contrast, injection site pain, chest pain, and allergic reaction were reported significantly more frequently in the placebo group.ConclusionsBTX-A has an acceptable safety profile for treatment of patients with focal spasticity following stroke, a population in which adverse events and comorbidities are common.

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