The Food and Drug Administration (FDA) has approved updated labeling for Optison (perflutren protein-type A microspheres injectable suspension, USP) that removes hypersensitivity to blood and blood products from the Contraindications section.
Optison is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. Each mL contains 5 to 8 x108 protein-type A microspheres, 10mg albumin human, and 0.22 ± 0.11mg perflutren.
The Contraindications section has been updated to: “Do not administer Optison to patients with known or suspected hypersensitivity to perflutren or albumin.” According to GE Healthcare, removing the contraindication to screen for hypersensitivity to blood and blood products will help to improve workflow efficiency for health care professionals. The FDA has never classified Optison as a blood product and no additional patient consent would be required.
Jonathan R. Lindner, MD, M. Lowell Edwards Professor of Medicine, Chief, ONPRC Division of Cardiometabolic Health, Oregon Health & Science University, said: “Ultrasound enhancing agents (UEAs) have been shown to improve patient care through improved diagnostic accuracy and greater confidence in interpretation of echocardiograms. Accordingly, the peeling away of precautions or contraindications for the use of UEAs that are not supported by science removes unnecessary hurdles to employing this valuable asset in cardiovascular imaging.”