GE updates Optison prescription info after FDA changes box warning
GE Healthcare has released updated prescribing information for its ultrasound contrast agent Optison, and will establish an external, independent safety monitoring board as well.
The changes come after a recent FDA safety review, in which the agency revised the benefit/risk assessment for all perflutren microsphere contrast agents, the class in which Optison belongs.
Changes to the prescribing information include removal of certain contraindications for the use of Optison in critically ill patients, which will allow physicians to use the agent to diagnose potentially life-threatening cardiac abnormalities, GE said. Additional changes include the removal of extensive monitoring requirements post-injection, in all but critically ill patients.
The contraindication section of the label has been revised to state: “Do not administer Optison to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Optison by intra-arterial injection.” GE said that all other contraindications have been removed from the Optison label.
The company said its boxed warning(s) sections have been revised to recommend monitoring in patients with pulmonary hypertension or unstable cardiopulmonary conditions only, according to the company. The previous label had included language regarding monitoring in all patients.
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. GE said it conducted a medical evaluation of the circumstances surrounding this recall and concluded, with FDA agreement, that “the probability of serious adverse events related to the use of the product was remote.”
The changes come after a recent FDA safety review, in which the agency revised the benefit/risk assessment for all perflutren microsphere contrast agents, the class in which Optison belongs.
Changes to the prescribing information include removal of certain contraindications for the use of Optison in critically ill patients, which will allow physicians to use the agent to diagnose potentially life-threatening cardiac abnormalities, GE said. Additional changes include the removal of extensive monitoring requirements post-injection, in all but critically ill patients.
The contraindication section of the label has been revised to state: “Do not administer Optison to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Optison by intra-arterial injection.” GE said that all other contraindications have been removed from the Optison label.
The company said its boxed warning(s) sections have been revised to recommend monitoring in patients with pulmonary hypertension or unstable cardiopulmonary conditions only, according to the company. The previous label had included language regarding monitoring in all patients.
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. GE said it conducted a medical evaluation of the circumstances surrounding this recall and concluded, with FDA agreement, that “the probability of serious adverse events related to the use of the product was remote.”