GE Healthcare Announces Updates To Optison Prescribing Information

GE Healthcare announced significant updates to the Prescribing Information (PI) for its ultrasound contrast medium OPTISON TM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). The Company also announced that it will establish an external, independent safety monitoring board for Optison. 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.

Changes 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 post-injection, in all but critically ill patients.

complete update at GE Healthcare