Imaging Contrast Agents Require New Warning Against Nephrogenic Systemic Fibrosis Risk

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Main Category: MRI / PET / Ultrasound
Also Included In: Radiology / Nuclear Medicine;  Urology / Nephrology;  Regulatory Affairs / Drug Approvals
Article Date: 10 Sep 2010 - 9:00 PDT

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Gadolinium-based contrast agents (GBCAs) should carry new warnings on the labels informing about the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal skin condition, the Food and Drug Administration (FDA) has announced. Magnevist, Omniscan, and Optimark will be described as unsuitable for use among patients with chronic severe kidney disease or acute kidney injury. Nephronic systemic fibrosis is a serious syndrome that involves the formation of excess fibrous connective tissue of the skin, joints, eyes and internal organs.

The new GBCA labels will stress the need to screen patients to determine whether there is any kidney dysfunction before administration.

The GBCAs have been approved by the FDA as intravenous drugs for use with MRI (magnetic resonance imaging) or MRA (magnetic resonance angiography) for the detection of abnormalities of body organs, blood vessels and tissues.

Symptoms of NSF may include hardening and tightening of the skin, scaling, red or dark skin patches, and stiffness. The condition is sometimes fatal, especially if body organs are affected.

After reviewing a wide range of GBCAs, the FDA identified Magnevist, Omniscan, and Optimark as the ones linked to a higher risk of developing NSF among patients with certain kidney diseases. According to available data, the administration of any GBCA may be followed by NSF, hence the Agency says it will continue to assess the safety of each CBGA.

Rafel (Dwaine) Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, said:

The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain agents among patients at highest risk for nephrogenic systemic fibrosis.

In the interests of patient safety, the FDA recommends that health care professionals:

• Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function
• Avoid using GBCAs if the patient is suspected or known to have impaired drug elimination, unless the imaging scan is essential and not available without contrast
• Monitor the patient for NSF signs and symptoms if the individual with acute kidney injury or chronic, severe kidney disease receives a GBCA
• During an imaging session, administer the GBCA only once

Below is a list of the relevant GBCAs and the companies that make and market them:

• Magnevist is marketed by Bayer Healthcare
• Omniscan is marketed by GE Healthcare
• Optimark is marketed by Covidien

Source: Food and Drug Administration (FDA)

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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