FDA: GE, Bayer, Covidien MR agents carry highest risk
After years of research regarding gadolinium-based contrast agents (GBCA) used during MRI being linked to the skin disease nephrogenic systemic fibrosis (NSF), the FDA has found the greatest risk in GE Healthcare’s Omniscan, Bayer HealthCare's Magnevist and Covidien’s Optimark.
FDA briefing materials, released Nov. 17, outlined the call for an appendage of stricter warnings on the aforementioned products, as well as an increased analysis of GBCA usage and the risk of NSF. The related risk to patients will be discussed in a joint Cardiovascular and Renal Drugs and Drug Safety and Risk Management advisory committee meeting, Dec. 8.
Back in 2006 and 2007, the FDA issued warnings that the deforming skin-disease NSF could be linked to the usage of gadolinium-based agents in patients who underwent MRIs, particularly in patients with a renal deficiency.
Since then, research has found that GE’s Omniscan—the second most commonly used GBCA—had 611 reported cases of patients who had undergone MRI with the agent and were later diagnosed with NSF. Bayer's Optimark had 455 reported cases.
Since these findings were released, a number of court cases against drug manufactures—particularly GE—have been filed. However, according to the FDA and its Office of Translational Sciences, “the magnitude of NSF risk does not compel removal of specific GBCAs from the U.S. market.
Because GBCAs are eliminated from the body by renal excretion, the FDA said, NSF has been found to be more prevalent in patients with renal deficiencies because the GBCA remains in the body for a prolonged period of time.
According to FDA briefing documents, discussion of GBCAs in the Dec. 8 meeting will weigh heavily on risk assessment, exposure and case data, appropriate methods of screening for the detection of renal impairments and communicating the risks of GBCA usage.
“The appropriateness of concluding that the GBCAs differ in the risk for NSF is one of the topics for the committee's discussion. If the committee regards the data as indicative of a difference in risk, FDA anticipates asking for advice on how best to describe this differential risk within labeling (or other communications),” the agency stated.
The Dec. 8 meeting will have a period of public comment pertaining to issues related to GBCAs and NFS.
FDA briefing materials, released Nov. 17, outlined the call for an appendage of stricter warnings on the aforementioned products, as well as an increased analysis of GBCA usage and the risk of NSF. The related risk to patients will be discussed in a joint Cardiovascular and Renal Drugs and Drug Safety and Risk Management advisory committee meeting, Dec. 8.
Back in 2006 and 2007, the FDA issued warnings that the deforming skin-disease NSF could be linked to the usage of gadolinium-based agents in patients who underwent MRIs, particularly in patients with a renal deficiency.
Since then, research has found that GE’s Omniscan—the second most commonly used GBCA—had 611 reported cases of patients who had undergone MRI with the agent and were later diagnosed with NSF. Bayer's Optimark had 455 reported cases.
Since these findings were released, a number of court cases against drug manufactures—particularly GE—have been filed. However, according to the FDA and its Office of Translational Sciences, “the magnitude of NSF risk does not compel removal of specific GBCAs from the U.S. market.
Because GBCAs are eliminated from the body by renal excretion, the FDA said, NSF has been found to be more prevalent in patients with renal deficiencies because the GBCA remains in the body for a prolonged period of time.
According to FDA briefing documents, discussion of GBCAs in the Dec. 8 meeting will weigh heavily on risk assessment, exposure and case data, appropriate methods of screening for the detection of renal impairments and communicating the risks of GBCA usage.
“The appropriateness of concluding that the GBCAs differ in the risk for NSF is one of the topics for the committee's discussion. If the committee regards the data as indicative of a difference in risk, FDA anticipates asking for advice on how best to describe this differential risk within labeling (or other communications),” the agency stated.
The Dec. 8 meeting will have a period of public comment pertaining to issues related to GBCAs and NFS.