Gadolinium Dear Doctor Letter

September 12, 2007

Gadolinium Dear Doctor Letter

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) causing a rare disease called Nephrogenic Systemic Fibrosis (NSF).

Dear Healthcare Professional (Dear Doctor Letter)

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)

MRI 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

Gadolinium Toxicity Lawsuit - Free Case Evaluation

If you or a loved one had a MRI or a MRA, and a Gadolinium-based contrast dye, medium or agent was used to enhance the MRI image, then your health may be at risk. If you developed Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), skin problems, skin tightening, severe joint problems, kidney failure, or renal failure, then you may be eligible to collect money damages for your injuries. Please contact us by calling 1-800-883-9858 or follow the link below for a free and confidential case evaluation.

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