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FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
Date:12/14/2008

is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Important Safety Information

LUSEDRA should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available.

The following serious adverse reactions have been reported with the use of LUSEDRA.

    -- Hypotension
       -- Hypotension was reported in 18/455 (4%) patients treated with
          LUSEDRA using the standard or modified dosing regimen.
       -- Patients with compromised myocardial function, reduced vascular
          tone, or who have reduced intravascular volume may be at an
          increased risk for hypotension.

    -- Hypoxemia
       -- Hypoxemia was reported in 20/455 (4%) patients treated with LUSEDRA
          using the standard or modified dosing regimen. Retention of
          purposeful responsiveness did not prevent patients from becoming
          hypoxemic following administration of LUSEDRA.

    -- Respiratory depression
       -- Apnea was reported in 1/455 (< 1%) patients treated with LUSEDRA
          using the standard or modified dosing regimen.

    -- Loss of purposeful responsiveness
       -- LUSEDRA has not been studied for use in general anesthesia. However,
          administration of LUSEDRA may inadvertently cause patients to become
          unresponsive or minimally responsive to vigorous tactile or painful
          stimulation. The incidence of patients who became minimally
          responsive or unresponsive to vigo
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SOURCE Eisai Corporation of North America
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