Drug Safety Developments

FDA Panel Suggests Bayer, GE MRI Drugs Be Restricted

Quoted from http://money.cnn.com/news/newsfeeds/articles/djf500/200912081857DOWJONESDJONLINE000551_FORTUNE5.htm

FDA Panel Suggests Bayer, GE MRI Drugs Be Restricted

December 08, 2009

By Jared A. Favole

Of DOW JONES NEWSWIRES

GAITHERSBURG, Md. -(Dow Jones)- A panel of medical experts on Tuesday suggested drugs made by General Electric Co. and Bayer AG 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.

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The FDA May Tighten Rules on Omniscan, a GE MRI Drug

Quoted from http://www.businessweek.com/bwdaily/dnflash/content/dec2009/db2009122_957825.htm

The FDA May Tighten Rules on Omniscan, a GE MRI Drug

An FDA review says MRI imaging drugs that contain gadolinium may be even riskier for kidney patients than it previously believed

By Jeff Gerth

 

Editor's Note: Gerth is a reporter with ProPublica, a nonprofit journalism organization in New York.

The U.S. Food & Drug Administration is weighing further regulation of three drugs used to create high-contrast images on MRI scans, based on a new analysis that suggests they carry a higher risk of causing a rare, but potentially fatal disease.

The issue, highlighted in an October story by BusinessWeek and ProPublica, marks a setback for GE Healthcare (GE), which contends that its product is no riskier than competing imaging drugs. FDA reviewers said GE's drug, Omniscan, had a disproportionately high number of reports of the disease compared with its peers.

An FDA advisory panel is scheduled to assess on Dec. 8 whether new restrictions or warnings are in order for the three drugs. The others are Bayer HealthCare's Magnevist, the market leader, and Optimark, made by Mallinckrodt.

All three have been associated with nephrogenic systemic fibrosis, or NSF, which can occur in patients with impaired kidney function. The drugs, which contain the metal gadolinium, are injected during magnetic resonance scans. Although the cause of NSF is uncertain, researchers theorize that an inability to eliminate gadolinium may be a factor. About 8 million vials of gadolinium-based imaging agents are sold each year. So far, the number of NSF cases numbers in the hundreds.

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US FDA sees varying risk from MRI agents

Quoted from http://www.reuters.com/article/marketsNews/idCNN1737499420091117

US FDA sees varying risk from MRI agents

 

By Lisa Richwine

WASHINGTON, Nov 17 (Reuters) - Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, U.S. drug reviewers said in documents released on Tuesday.

The Food and Drug Administration said a staff review found the highest risk of the skin disease, nephrogenic systemic fibrosis (NSF), was associated with GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark.

The lowest risk was associated with Prohance and Multihance, made by Bracco Diagnostics, the agency said, adding "the data do not appear to rule out an NSF risk for each of the agents."

The agency said the staff review that found variations among the drugs had limitations and it would take the issue to a panel of outside experts that meets in December.

The products, used to help make MRI scans easier to read, have been given to millions of patients. They are members of a family known as gadolinium-based imaging agents. The FDA announced in 2007 it was requiring a strong "black box" warning on all of the drugs to alert physicians that patients with certain kidney and liver conditions were at risk for for NSF.

Staff in the FDA's drug safety unit said the magnitude of the risk "does not compel removal of specific (imaging agents) from the U.S. market" but recommended that the drug labels note the varying levels of risks with each product.

NSF triggers thickening of the skin, organs and other tissues that makes it difficult to move and can lead to broken bones, although the exact cause is unclear. There is no effective treatment.

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