RX Ims Health, Inc.

A panel of medical experts Tuesday will consider whether new warnings should be added to a class of drugs made by General Electric (GE), Bayer AG (BAYRY), Covidien Plc (COV) and others amid reports they may cause skin to thicken and harden.

The drugs are widely used to enhance images of the body when patients undergo magnetic resonance imaging, or MRIs. Bayer's Magnevist is considered the market leader and 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.

Federal health authorities in the U.S. and Europe have received dozens of reports of patients whose skin hardened and thickened, particularly around joints, after taking some of these drugs. These products, also called contrast agents, contain the element gadolinium, which can be toxic if it seeps into a patient's tissue.

The U.S. Food and Drug Administration now wants a panel of medical experts on Tuesday to consider whether the labels need to be updated with new warnings.

GE's Omniscan, Bayer's Magnevist and Covidien's Optimark appear most likely to get a label change. A new scientific analysis shows the three drugs put patients at a "greater risk" of suffering from hardened and thickened skin than other products in the same class, the FDA said in briefing documents posted on its Web site ahead of the meeting.

There are a total of seven FDA-approved contrast agents that contain gadolinium and the agency wants the panel to consider whether new warnings should be added to all seven drugs, or just some.

The labels for the drugs already include warnings that they may pay put patients with severe kidney insufficiency at risk for nephrogenic systemic fibrosis, a disease that thickens and hardens the skin and can limit mobility and be fatal. There is no known cure for the disease.

GE and other companies are facing hundreds of lawsuits on behalf of patients who allege the product caused their skin to thicken and harden.

GE says its label shouldn't be updated because doctors are already aware of the risks and have stopped using Omniscan in patients who have severe kidney failure.

"Given that there have been no new cases reported to GE since late 2007, we know that current labeling and clinical protocols have been effective in drastically reducing the risk of NSF for patients," said GE spokesman Ryan Fitzgerald. He added, "That shows that the core issue is one of appropriate patient selection, not differences between [contrast] agents."

It's unclear exactly why some of the contrast agents appears to put patients at greater risk than others. It may have to do with the molecular structure of the medicine, said Dr. Charles Bennett, a senior research associate at Jesse Brown VA Medical Center in Chicago.

He said Omniscan and Magnevist, for instance, use a linear bond to bind the galodinium to the contrast agent. Others use a closed ring to bind the galodinium and ensure it stays in the blood stream and doesn't break off into tissues or major organs.

He said the linear products bind the galodinium "like a rope" and can easily allow the toxic element to break free, while others use a circular bond that acts "like a big security blanket."

Bennett has received a grant from the federal government to study contrast agents and nephrogenic systemic fibrosis. He said he has also been an expert advisor for some plaintiffs who are suing companies that make the contrast agents.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com

Grafico Azioni IMS Health (NYSE:RX)
Storico
Da Apr 2024 a Mag 2024

Grafico Azioni IMS Health (NYSE:RX)
Storico
Da Mag 2023 a Mag 2024