The Food & Drug Administration ordered gadolinium-based drug makers to update the warning labels on their products.
The contrast agent, which is used to improve image quality in magnetic resonance imaging and magnetic resonance angiography, has been associated with an increased risk for nephrogenic systemic fibrosis in individuals with kidney problems.
The FDA determined that the gadolinium-based contrast agents Magnevist, Omniscan and Optimark are associated with a greater risk of NSF than other GBCAs for patients with kidney disease and advises against their use in patients with acute kidney injury or chronic, severe kidney disease. The watchdog agency also said that enhanced screening to identify NSF risk is necessary and advises doctors to report cases of the syndrome. GBCAs are marketed in the U.S. under the names Ablavar, Eovist, Magnevist, Multihance, Omniscan, Optimark and Prohance.
The FDA said the labeling change includes the following recommendations for healthcare professionals:
- Not use three of the GBCA drugs — Magnevist, Omniscan, and Optimark — in patients with AKI or with chronic, severe kidney disease. These three GBCA drugs are contraindicated in these patients.
- Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.
- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.
- Features of AKI consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess kidney function in the setting of AKI.
- For patients at risk for chronically reduced kidney function (such as patients over age 60 years, patients with high blood pressure, or patients with diabetes), estimate the kidney function (GFR) through laboratory testing.
- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.
- Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.
- Preventive Care and Screening: Influenza Immunization for Patients 50 old or older
- Do not repeat administration of any GBCA during a single imaging session.
In 2006, the watchdog agency began warning the public in about cases of NSF in GBCA-treated patients. The following year, the agency began requiring the addition of a boxed warning about the risk of NSF to the labeling of GBCA drugs. In December 2009, an FDA advisory panel recommended that the watchdog agency tighten restrictions on the drugs.