GE Healthcare Announces FDA Labeling Change for Optison Ultrasound Contrast Agent

October 4, 2016 — GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound contrast agent Optison (Perflutren protein-Type A Microspheres Injectable Suspension, USP). The FDA removed the contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection. Both contraindications have been revised and moved to the WARNINGS AND PRECAUTIONS section (5.3 : Systemic Embolization) of the Full Prescribing Information.

Optison is the first contrast agent available in the United States to receive this contraindication label change.

A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal flow of the circulatory system. Previously, in suspected cardiac shunt populations, an agitated saline procedure was needed to determine if a shunt existed and whether the patient was contraindicated to receive an ultrasound contrast agent.

Sharon L. Mulvagh, M.D., professor of medicine, Women's Heart Clinic director, associate director, preventive cardiology consultant in cardiovascular diseases, Mayo Clinic and Mayo Clinic College of Medicine, said: "I am very pleased that the FDA has approved the removal of the cardiac shunt contraindication from the ultrasound contrast agent Optison. This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases.”

She added: “This is an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”

Steven Feinstein, M.D., co-president of the International Contrast Ultrasound Society, said: “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging. The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system.”

Jonathan Lindner, M.D., M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University, said: “Thanks to the overwhelming weight of evidence from clinical trials, most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small. The decision by the FDA removes a barrier to using this contrast agent, and may result in an increase in the number of labs that will choose to utilize this important technology, which allows clinicians to provide the best care possible.”

For more information: www.gehealthcare.com