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FDA-MedWatch -Gadolinum Based Contrast Agents: Dear Healthcare Professional Letter Issued Regarding Boxed Warning And Revisions to Warning Section of Prescribing Information

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ROCKVILLE, Md., Sept. 28, 2007--Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI).

Read a portion of the Dear Healthcare Professional letter below. The entire letter is attached. 

Important Drug Warning for Gadolinium-Based

Contrast Agents

Magnevist® (gadopentetate dimeglumine) Injection

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL

Omniscan™ (gadodiamide) Injection

OptiMARK® (gadoversetamide) Injection

ProHance® (Gadoteridol) Injection, 279.3 mg/mL

September 12, 2007

Dear Healthcare Professional,

The manufacturers of gadolinium-based contrast agents would like to inform you of important revisions to the prescribing information for the products listed in alphabetical order above. Gadolinium-based contrast agents are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI).

Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.

NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF is progressive and may be debilitating or fatal. As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.

As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the WARNINGS section.

Call 1-800-FDA-1088 (1-800-332-1088)

Posted: September 2007