Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, supports the U.S. Food and Drug Administration's (FDA) announcement requiring safety-related label changes for all gadolinium-based contrast agents to highlight the rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF). Of the seven gadolinium-based contrast agents currently approved for use in the United States, three of them are now being required by FDA to include certain new contraindications relating to severe kidney disease. No substantial changes will be required by FDA to the ABLAVAR® (gadofosveset trisodium) prescribing information. ABLAVAR® is a unique, single, low dose injectable magnetic resonance angiography (MRA) blood pool imaging agent for use to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD). ABLAVAR® is the first and only imaging agent with an FDA-approved indication for use with MRA.
"We support the FDA for taking action to ensure the safe and appropriate use of gadolinium-based contrast agents, and we agree with the changes put forth by the FDA for ABLAVAR®," said Mark Hibberd, M.D., Ph.D., Senior Medical Director, Lantheus Medical Imaging, Inc. "The revised language provides clearer guidance to healthcare professionals about the risk of gadolinium-based contrast agent-associated NSF in patients who are renally impaired. ABLAVAR® is uniquely designed for vascular imaging and has a strong safety profile. To date, there have been no reported incidents of NSF with ABLAVAR®. We remain committed to working with the FDA to provide the most current and accurate safety information for the product."