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FDA Approves Fospropofol Disodium for Monitored Anaesthesia Care Sedation NEW YORK -- December 15, 2008 -- The US Food and Drug Administration (FDA) has approved fospropofol disodium (Lusedra) injection for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures. Hypotension was reported in 4% (18/455) patients treated with fospropofol disodium using the standard or modified dosing regimen, and hypoxaemia was reported in 4% (20/455) patients. Apnoea was reported in less than 1% of patients. Although fospropofol disodium has not been studied for use in general anaesthesia, it has inadvertently caused patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence was 4% (7/183) for colonoscopy and 16% (24/149) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients. The most common adverse reactions (>20%) are paresthesia and pruritus. SOURCE: Eisai Corporation of North America E-mail this page to a friend or colleague! To print, use this version