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