GE Healthcare of Chalfont St. Giles, U.K., has issued updates to the prescribing information for Optison (perflutren protein-type A microspheres injectable suspension, USP).
The company also will create an external, independent safety monitoring board for its ultrasound contrast agent.
These changes come after a recent U.S. Food and Drug Administration (FDA) safety review in which the agency revised the benefit/risk assessment for all perflutren microsphere contrast agents.
GE's revisions to the prescribing information include removal of certain contraindications for the use of Optison in critically ill patients, which will enable physicians to use the agent to diagnose potentially life-threatening cardiac abnormalities. Additional changes include the removal of extensive monitoring requirements postinjection in all but critically ill patients.
GE also is sending a letter to notify healthcare providers of the changes.
Optison returned to the U.S. market in October 2007 after a nearly two-year absence due to a voluntary recall related to manufacturing issues.
More information on the label change is available at www.gehealthcare.com.
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