CORRECT (12/8):FDA Panel Suggests Bayer, GE MRI Drugs Be Restricted

A panel of medical experts on Tuesday suggested drugs made by General Electric Co. (GE) and Bayer AG (BAYRY, BAYN.XE) be restricted to people without severe kidney problems amid reports they may cause a fatal thickening and hardening of the skin.

The group was formed to help the U.S. Food and Drug Administration determine whether the products labels needed to be updated to restrict them to certain patients.

GE's Omniscan and Bayer's Magnevist are among seven FDA-approved products containing gadolinium that are used to enhance images when patients undergo magnetic resonance imaging or similar procedures. The FDA and regulatory agencies in Europe have received hundreds of reports of patients with severe kidney disease who have taken the products and suffered from nephrogenic systemic fibrosis, a potentially fatal skin condition. In November, Europe's health regulatory agency said GE's Omniscan, Bayer's Magnevist and Covidien Ltd.'s (COV) Optimark shouldn't be used in patients with severe kidney problems.

The panel struggled with determining whether some or all of the seven-FDA approved drugs should be restricted. The FDA has said Omniscan, Magnevist and Optimark appear to put patients at a higher risk for nephrogenic systemic fibrosis than similar drugs. The panel reached a consensus that Omniscan and Optimark needed to be restricted. Panel members also said Magenvist needed to be restricted, but to a lesser extent than Omniscan and Optimark.

Magnevist had 2008 U.S. sales of about $204 million, according to IMS Health Inc. (RX), a health information company. GE's Omniscan had U.S. sales during the same time frame of $80 million.

Covidien officials said Wednesday they have already agreed to update the product's label in the U.S.

The labels for the products were updated by the FDA in 2006 to warn that using them in patients with severe kidney disease may cause nephrogenic systemic fibrosis. Radiologists told the FDA that clinicians have essentially stopped using the products in these patients, and the FDA's Robert Boucher said the number of reports of nephrogenic systemic fibrosis have dropped significantly since the 2006 warning.

Panel members said the labeling for the products needs to keep pace with how the drugs are being used in the real world. "The practice is way ahead of the label now and we need to get these two matched up," said panel member Peter Choyke, a radiologist with the National Cancer Institute.

It's unclear what changes if any the FDA will ultimately take, though the agency generally follows the panel's advice. Dr. Dwaine Rieves, head of the FDA's imaging division, acknowledged that the label hasn't kept up with clinical practice. Still, he said, the panel's thoughts are relevant because they will help the FDA when it considers similar drugs that are up for approval. A French company told the FDA during a public comment period that it intends to file to get approval to sell a drug with gadolinium that would enhance images during MRIs.

GE said in a statement that the current labeling for Omniscan is adequate and shouldn't be updated. Clinical practices have already changed, the company noted, "rendering additional label changes unnecessary."

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@dowjones.com

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