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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

Image Credit: |

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks
Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks (Posted 2 days ago)

Women who used Johnson's Baby Powder around their genitals for feminine hygiene purposes now live in fear of developing ovarian cancer, according to the class action lawsuit seeking medical monitoring for future diagnoses

More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing
More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing (Posted 3 days ago)

A bundled complaint of about 9,600 Suboxone lawsuits were filed in federal court on Friday, ahead of the two-year anniversary of the FDA requiring tooth decay label warnings on the opioid treatment film strips, which is also a deadline for filing a civil complaint in many states.