Greater risks seen with certain imaging agents: FDA

By Susan Heavey

WASHINGTON (Reuters) - A U.S. Food and Drug Administration review found the risk of a serious skin disorder is greater with MRI imaging contrast agents made by GE Healthcare, Bayer AG's and Covidien, according to an agency memo released on Wednesday.

The review recommended that labels for the products -- GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark -- recognize their greater risk for the potentially fatal disorder over rival agents, it said.

FDA officials released the memo ahead of a December 8 meeting to discuss the risks with all gadolinium-based contrast agents, which already carry a "black-box" warning about the increased potential for the condition in patients with kidney problems.

But the agency is weighing whether the label warnings should be product-specific. It plans to seek advice from its panel of outside experts at the meeting, it said in the memo.

Gadolinium-based contrast agents (GBCAs) are injected in patients undergoing magnetic resonance imaging (MRI) scans to help make the resulting images easier to see and interpret.

The FDA ordered the class-wide warning in 2007, noting that the disorder, called nephrogenic systemic fibrosis (NSF), thickens the skin and other tissues and can inhibit movement. It also called on companies to study the issue.

In Wednesday's memo, the FDA said its review linked GE's Omniscan to the most reports of NSF. The disorder was also reported with other agents, it said, but other issues such as off-label use made it difficult to assess the risk for each product.

GE Healthcare, a unit of General Electric Co, said the class-wide label warnings "have contributed to a dramatic reduction in the occurrence of NSF in patients receiving" the agents. But it disputed the notion that certain products are worse than others.