Federal regulators plan to meet in December to review a 2007 decision to issue a blanket warning about the risks of special imaging drugs that are injected as part of MRI scans.
The U.S. Food and Drug Administration’s determination went against the urging of two reviews that year by FDA doctors who found that an imaging agent made by General Electric presented a greater risk in patients with severely impaired kidneys.
As we reported yesterday, hundreds of MRI patients who had serious kidney problems have contracted a rare, debilitating and sometimes fatal disease called nephrogenic systemic fibrosis (NFS) after being injected with contrast agents that contain the toxic metal gadolinium.
GE and other manufacturers of the agents all deny liability. As a result of the FDA action in 2007, they have all placed a "black box" warning on the drugs’ labels to caution doctors who are weighing whether to use them in patients with kidney disease.
Dr. John Jenkins, director of the FDA’s office of new drugs, said in an interview that the agency’s advisory committee on drug safety will revisit the decision on warnings and "see if we need to make any changes" addressing the relative risk of different agents.
Regulators in Europe, as well as the American College of Radiology, have issued stronger warnings than the FDA about GE’s drug, called Omniscan, saying it appeared to be associated with a larger number of NSF cases than its market share would suggest.
GE says there is no evidence that its drug causes NSF but has cautioned against using it with patients who have severe kidney problems. The company’s position paper on Omniscan and NSF is here.
The FDA’s medical review of NSF concluded there was an "undeniable and strong association" between the gadolinium-based agents and the disease. Although its own reviewers said the risks of Omniscan appeared greater, the agency decided that all five such agents marketed in the U.S. should have black box warnings.
A key reason for the agency’s decision to treat the agents as a class was the lack of data, according to R. Dwayne Rieves, the head of the division responsible for the decision.
But since the 2007 action, a detailed database on NSF cases and MRI scans has been jointly developed by the manufacturers and lawyers for plaintiffs who are litigating several hundred lawsuits in federal court.
Next week, Dr. Rieves has agreed to hear about newly developed NSF information from Dr. Emanuel Kanal, a leading radiologist and critic of the FDA’s stance.
