14-Sep-10 9:00 AM  CST

FDA Warns of Serious Condition Related to MRI Drugs

The FDA has issued an alert to health care professionals that MRI imaging drugs containing gadolinium put patients with kidney disease at risk for contracting a rare, potentially fatal skin disease.

Gadolinium-based contrast agents (GBCAs) are intravenous drugs used in patients having MRIs or magnetic resonance angiographies (MRAs) to improve the quality of the image. Use of GBCAs can lead to a condition called nephrogenic systemic fibrosis, a rare and serious disorder where excessive fibers lead to scaling and hardening of skin tissue along joints and internal organs. Though not much is known about the cause of the disease or how to cure it, the disease appears to be associated with gadolinium. Patients with impaired kidney function have the most difficulty excising gadolinium from their bodies, putting them at high risk of contracting NSF.

In 2006, the FDA investigated the reports of 25 cases of patients who had contracted NSF after taking a GBCA for their magnetic resonance angiography (MRA) exams. The agency traced it to the gadolinium present in the contrast agents and put a black box warning on all GBCAs in 2007. 

The FDA is now requiring manufacturers of GBCAs to include guidelines for health care professionals and patients on their drug labels to ensure the drugs are used safely. The FDA said that health care professionals should avoid using Magnevist, Omniscan and Optimark in patients with kidney disease as these pose greater risk for NSF than other GBCAs.

The agency also recommends that health care professionals screen patients for kidney illnesses before administering GBCAs and check patients’ clinical history for signs of acute and chronic kidney illnesses. A complete list of guidelines for health care professionals and patients is available on the FDA Drug Safety and Availability web page.

Approved GBCAs on the market are Ablavar, Eovist, Magnevist, MultiHance, ProHance, Omniscan and Optimark. They are manufactured by Lantheus Medical Imaging (Ablavar), Bayer (Eovist and Magnevist), Bracco Diagnostics (Multihance and Prohance), GE Healthcare (Omniscan) and Covidien (Optimark) respectively.

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Source: NPTANews  

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