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May 30, 2007, United Press International

Magnevist: Woman sues Bayer over son's death

A Ohio woman has filed suit against drug maker Bayer, alleging the company's drug Magnevist caused her 24-year-old son's death in 2004.

The suit, which was filed in the U.S. District Court in Cleveland and is the first against Bayer for Magnevist, seeks compensatory and punitive damages, according to the Cleveland law firm of Spangenberg, Shibley and Liber.
Magnevist, a contrast agent containing the heavy metal gadolinum, is used to help visualize internal organs and blood vessels.

Beverly Rockwell, the mother of Trevor Drake, alleges the drug caused a skin and joint disease known as nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy, (NSF/NFD), in her son.

Drake suffered from kidney problems and had been on dialysis since the age of 19. A kidney transplant attempted when he was 21 failed. The Cleveland Clinic injected Drake with Magnevist in 2002 prior to a magnetic resonance imaging for end-stage kidney disease.
Last week, the Food and Drug Administration asked manufacturers to include a black box warning on the labeling of all gadolinium-based contrast agents that the drugs increase the risk of NSF/NFD in patients with severe kidney problems.

May 24, 2007, MedScape Alert

FDA Requests Boxed Warning for Gadolinium Based Contrast Agents

Healthcare professionals have been notified of a US Food and Drug Administration (FDA) request for the addition of warnings (including a boxed warning) to the safety labeling for gadolinium-based contrast agents (GBCAs) used to enhance the quality of magnetic resonance imaging, the agency announced yesterday.

The revisions are intended to highlight the risk for nephrogenic systemic fibrosis (NSF; also known as nephrogenic fibrosing dermopathy NFD) after GBCA exposure in certain patient populations, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

These include patients with acute or chronic severe renal insufficiency (defined as glomerular filtration rate GFR < 30 mL/min/1.73 m2), acute renal insufficiency due to hepatorenal syndrome, and those in the perioperative hepatic transplantation period. Use of GBCA in these settings should be avoided unless information of essential importance is not available by alternate means.

The FDA has previous warned healthcare professionals regarding cases of NSF after single and multiple administration of GBCAs. Although the cases were not limited to any particular agent, gadodiamide (Omniscan; GE Healthcare) was most frequently implicated, followed by gadopentetate dimeglumine (Magnevist; Bayer Schering Pharma), and gadoversetamide (OptiMARK; Mallinckrodt, Inc).

NSF also has been reported in connection with sequential administration of gadodiamide and gadobenate dimeglumine or gadoteridol (MultiHance and ProHance; Bracco Diagnostics, Inc). The FDA notes that because exposure is inadequately described in these reports, it remains unclear whether the risk is similar for all 5 approved GBCAs.

Healthcare professionals are reminded to screen patients for renal problems prior to use of these imaging agents. Also, dose recommendations should not be exceeded and enough time should be given to allow product clearance prior to its reuse.

Patients at risk for NSF should be closely observed after gadolinium exposure and instructed to contact a healthcare professionals regarding potential symptoms such as skin burning, itching, reddened/darkened patches and/or inflammation, hardening, and/or tightening; yellow raised spots on the sclera; joint stiffness; limited range of peripheral movement; deep hip/rib pain; and/or muscle weakness.

Although there is no known treatment for the condition, improved renal function (spontaneous or via renal transplantation) appears to slow or arrest its development and may even yield a gradual reversal of the condition.

Healthcare professionals are encouraged to report cases of NSF potentially associated with exposure to gadolinium-containing contrast agents to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. Yael Waknine