In the German/Austrian retrospective study, adverse events (AE) were, in general, uncommon. Of the 945 patients, 90.6% (n = 856) did not experience any AE over any treatment cycle. The total AE rate per treatment cycle was 4.1% (n = 39/945) in cycle one, decreasing to 2.0% (n = 11/553) in cycle five, giving an overall mean incidence of 2.5% per treatment cycle. Importantly, most AEs were mild and resolved without further intervention. There were no serious or unexpected AEs.

Local hematoma was the most frequently reported AE (1.25% per treatment cycle; range: 1.8-0.7%). Lid or brow ptosis was uncommon (0.46% of treatment cycles; range: 0.85-0.1%) and generally mild. All patients who experienced lid or brow ptosis (n = 16) received injections to the glabella or frontalis. A total of 3698 treatments in the glabella or frontalis were given to 907 patients. Therefore, the incidence of lid or brow ptosis in patients who received injections to the glabella and/or frontalis regions was 0.51% per treatment cycle or 1.8% per patient (Rzany et al. 2007).

Answer to key question 4: The risk for eyelid ptosis after repeated treatments is very small.

Please note that further information on safety is available in Chapter 7.

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