Sept. 10: This post has been updated.
The U.S. Food and Drug Administration said today that GE Healthcare’s Omniscan and two other MRI drugs should not be used in patients with severely impaired kidneys because they risk developing a rare but potentially fatal disease.
The decision marks a turnabout for the FDA and brings U.S. labeling requirements for Omniscan and the other drugs more in line with those in Europe, where an association first surfaced between Omniscan and the disease, nephrogenic systemic fibrosis, or NSF.
ProPublica reported last year on GE Healthcare’s efforts to defend Omniscan, and on the company’s attempt to muzzle a Danish radiologist who criticized the drug.
Magnevist, the market leader, sold by Bayer HealthCare, and Optimark, which is sold by Covidien, are also affected by the FDA’s announcement Thursday.
Covidien last year acted on its own to contraindicate use of Optimark for at-risk kidney patients. But GE and Bayer continued to assert that their drugs were no riskier than the other so-called contrast agents, which are used to make MRIs easier to read.
The FDA has approved seven such drugs for use in the United States.
GE Healthcare and Bayer issued statements Thursday emphasizing their continued concern about patient safety and pointing out that tens of millions of doses have been used as diagnostic tools without any adverse effects.
GE said it would update Omniscan’s label to reflect that the drug should not be administered to patients with severe kidney damage. Bayer said it would respond to the FDA’s action within 30 days.
The first link between contrast agents containing gadolinium, a heavy metal, and NSF, a crippling condition with potentially lethal complications, surfaced in 2006. The next year, the FDA recommended a “black box” warning for at-risk kidney patients.
The agency decided to treat all the drugs as a class, ignoring two of its own medical reviewers, who said Omniscan was associated with a disproportionately high share of NSF cases and wanted to ban its use in patients with severe kidney conditions.
Since 2007, all contrast drugs sold in the U.S. have carried the same warning on their labels. Regulators in Europe, by comparison, acted that year to contraindicate use of Omniscan, Magnevist and Optimark in patients with severe kidney disease.
Amid continuing concerns about safety last year, the FDA convened two advisory panels in December to look at the issue again. The agency’s scientists had done further research and concluded that warning labels for the three drugs should be made sterner.
The panels recommended a ban on Optimark and Omniscan. But while some panel members also voiced concerns about Magnevist, there was a wide range of opinions about what to do and no consensus.
The FDA normally follows the recommendations of its advisory panels.
More than 110 million doses of Magnevist have been sold worldwide, according to Bayer; GE Healthcare says Omniscan, the nearest competitor, has been used more than 48 million times.
All the manufacturers deny that their drug causes NSF. Omniscan has been linked to more of the reported cases of the disease than any other drug and has been named in more lawsuits than the other drug companies.
Since the disclosure of the disease the market share of Omniscan has fallen by about one half and the percentage of a less risky drug, MultiHance, made by Bracco Diagnostics, has risen, according to FDA data presented last December.
In addition to banning the three drugs for some, the FDA urged better screening to discover at-risk patients before using any of the gadolinium-based agents, which are administered intravenously, and closer monitoring of patients for signs of NSF afterward.
NSF has not been reported in patients with healthy kidneys, the FDA said. The disease, marked by scaling, hardening and tightening of the skin, or red or dark patches, can also cause fibrosis of internal organs that may lead to death, the FDA said.
New reports of NSF have virtually disappeared thanks to heightened awareness about the condition.
Update: Covidien has issued a statement in response to the FDA's action.