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Novartis Exelon Labeling Update Reflects Report Of Esophageal Rupture

Executive Summary

Novartis' revised labeling for the Alzheimer's agent Exelon (rivastigmine) directs that therapy should be reinitiated at the lowest daily dose following treatment interruption in order to reduce the risk of severe vomiting and esophageal rupture.

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Novartis Exelon

Firm clarifies that two-week or longer intervals between dose increases of Alzheimer's agent in postmarketing has resulted in "improved tolerability as evident from fewer GI complaints than seen in pivotal studies." The company previously said that rivastigmine postmarketing nausea/vomiting reports have been consistent with rates seen in clinical trials (1"The Pink Sheet" Feb. 5, p. 24)

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