Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

FDA Approves New Gadolinium Dye

Posted in Uncategorized

The FDA recently approved the Gadolinium dye EOVIST to be used to help detect liver problems.  This makes EOVIST somewhat unique because it’s approved to target problems with specific organs.  Like all Gadolinium dyes, this one also carries an FDA black box warning:

“Gadolinium-based contrast agents increase the risk of Nephrogenic Systemic Fibrosis in patients with:

— acute or chronic severe renal insufficiency (glomerular filtration) rate <30 mL/min/1.73 m2), or
— acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid the use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

As with other contrast media, the possibility of serious or life- threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache.”

EOVIST is made by Bayer, the company that also made the deadly drug Trasylol.  Let’s hope EOVIST is a safer drug.