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FDA adds warning to gadolinium-based contrast agents
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The FDA is now requiring that gadolinium-based contrast agents carry new label warnings about the risk for nephrogenic systemic fibrosis, a rare but potentially fatal condition, if the drug is given to certain patients with kidney disease, according to a press release.
All gadolinium-based contrast agent labels will now urge physicians to screen patients for acute kidney injury or chronic severe kidney disease before administering the drug. Three gadolinium-based contrast agents — Magnevist (Bayer Healthcare), Omniscan (GE Healthcare) and Optimark (Covidien) — were associated with a greater risk for nephrogenic systemic fibrosis development and will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease, according to the release.
Nephrogenic systemic fibrosis is a condition involving the formation of excess fibrous connective tissue in the internal organs, skin, joints and eyes. Symptoms can include scaling, tightening and hardening of the skin, dark patches on the skin and stiffness. If the internal organs are involved, the condition can be fatal, according to the release.
“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,” Rafel Rieves, MD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA has issued the following recommendations for physicians using gadolinium-based contrast agents:
- Estimate kidney function via laboratory testing for patients at risk for chronically reduced kidney function.
- Do not use gadolinium-based contrast agents in patients suspected or known to have impaired drug elimination unless the imaging is absolutely necessary and not available without contrast.
- Monitor for signs and symptoms of nephrogenic systemic fibrosis if a gadolinium-based contrast agent is administered to a patient with acute kidney injury or chronic severe kidney disease.
- Only administer a gadolinium-based contrast agent once during an imaging session.
For more information, view the FDA’s “Gadolinium Safety Announcement” or “Questions and Answers Page on Gadolinium-Based Contrast Agents.”
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