Covidien Backs FDA Safety Warning

| About: Medtronic plc (MDT)

Ireland-based health care product maker Covidien plc (COV) has backed the U.S. Food and Drug Administration's (FDA) recent labeling changes for Gadolinium-based contrast agents (GBCAs) for patients with renal diseases. GBCAs, which contain the chemical element gadolinium, are injectable drugs that are frequently used in magnetic resonance imaging (MRI) scans.

The FDA released a mandate on September 9, 2010, which requires warnings to be issued on the use of specific GBCAs. This directive calls for a label update for these GBCAs due to the risk of nephrogenic systemic fibrosis (NSF) if they are used in patients with kidney disease. NSF is a rare and potentially fatal disorder characterized by the hardening of the skin, eyes and internal organs.
The association of NSF with GBCAs can be traced back to 2006 when the FDA reported cases of NSF in renal failure patients. Since then, the regulator has been monitoring the effects of all GBCAs for their potential to cause this serious disease.
In its statement, the FDA has marked three of the currently marketed GBCAs which can potentially cause NSF. These are Magnevist by Bayer Healthcare, a subsidiary of Bayer AG (OTCPK:BAYRY), Omniscan by GE Healthcare, a unit of General Electric (NYSE:GE), and Optimark by Covidien. The agency has called for the strongest warning label for these three contrast agents.
The FDA has stated that the updated warning labels must contraindicate the use of the three flagged GBCAs in patients with acute kidney injury or chronic severe kidney disease as they are highly susceptible to developing NSF. Moreover, the new label will indicate the need for screening all patients for kidney disease before administering any of these drugs.
While applauding the FDA’s move to ensure patient safety, Covidien stated that the agency’s action is consistent with the company’s step in November 2009, when it voluntarily contraindicated the use of Optimark in MRI procedures in patients with severe kidney disease. The label change was intended to make sure Optimark is used in the appropriate patient population.