The U.S. Food and Drug Administration (FDA) has approved the removal of hypersensitivity to blood and blood products from the listed contraindications for GE Healthcare's Optison echocardiography contrast agent.
As a result, Optison's prescribing information now only includes a contraindication in patients with known or suspected hypersensitivity to perflutren or albumin.
GE said it was pleased with the FDA's decision, noting that no reported cases of blood or blood product hypersensitivity reactions have been reported in the three million patients who have received Optison since it was approved in 1997. Furthermore, no other albumin products on the market have this contraindication, according to the vendor.
FDA-mandated warnings -- such as the longstanding black-box warning and a recently added contraindication for two other agents in patients with known allergies to polyethylene glycol -- have long been a sore subject for proponents of ultrasound contrast media.
Eliminating precautions or contraindications for the use of ultrasound-enhancing agents that are not supported by science removes unnecessary hurdles to utilizing these valuable assets in cardiovascular imaging, said Dr. Jonathan Lindner of Oregon Health & Science University in a statement from GE. The contraindication change will improve workflow efficiency for clinicians as they no longer have to screen for hypersensitivity to blood and blood products, according to the vendor.
Furthermore, GE noted that Optison has always been classified as a medical imaging drug -- not a blood product. Therefore, there continues to be no related religious-based objection and no additional patient consent is required, the company said.
