Nephrogenic Systemic Fibrosis Warnings to be Reviewed Again by FDA

An FDA advisory committee is planning to review a decision by the agency to place the same warning on all gadolinium-based MRI contrast agents about the risk of nephrogenic systemic fibrosis (NSF), as reports suggest that GE Healthcare’s Omniscan (gadodiamide) may be associated with a much greater risk for the debilitating and potentially life-threatening condition.

The FDA ordered the manufacturers of all gadolinium MRI contrast agents to add a “black box” warning in 2007, indicating that individuals with severe kidney problems could develop the rare disorder, also sometimes referred to as nephrogenic fibrosing dermopathy (NFD), which causes widespread areas of tight, thick and rigid skin that severely restricts movements. It can also result in scarring to internal organs and ultimately may be fatal.

A joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled for December 8. The two committees will review the FDA’s decision to provide the same warning to healthcare professionals and patients.

Out of the five approved gadolinium contract agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. Although GE’s contrast agent only accounts for about 30% of the market, it has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, according to a report by ProPublica.

The FDA’s decision to require the same black box warning for all MRI drugs that use the metal gadolinium went against the advice of two of its own staff doctors. The two FDA doctors each recommended more attention be placed on Omniscan, and that it possibly be banned for use in some patients.

At the meeting in December, the advisory committee will revisit the decision to treat all of the contrast agents the same and determine whether any changes are necessary.