OptiMARK – Another Contrast Agent with a High Risk of NSFOptiMARK, along with Omniscan and Magnevist, is one of three gadolinium-based contrast agents the FDA now recognizes as having the greatest risk of causing NSF. OptiMARK is the brand name for the gadolinium-based contrast agent (GBCA) manufactured by Mallinckrodt. OptiMARK’s generic name is gadoversetamide. OptiMARK is sometimes referred to in medical records as Gd-DTPA-BMEA.
OptiMARK’s chemical formulation is very similar to Omniscan. Along with Omniscan, OptiMARK is over 1000 times less stable than their main competitor, Magnevist. Like Omnisan, it has a linear non-ionic molecular structure.
The FDA approved OptiMARK in 1999. However, on September 9, 2010, the FDA announced that OptiMARK's label should warn that it should never be used on patients with acute kidney injury or chronic, severe renal impairment. Before this, there was no contraindication for OptiMARK, only a warning that the use of all GBCAs be avoided unless the diagnostic information was essential and not available with non-contrast enhanced magnetic imaging. The warning change followed a determination by FDA staff members in the Fall of 2009 that Omniscan, Magnevist and Optimark were the three most dangerous GBCA brands.
OptiMARK has approximately a 5% market share in the United States of gadolinium-based contrast agents. Nevertheless, it has caused a disproportionate number of NSF cases relative to its small market share.
The manufacturer of OptiMARK recently changed its warning label so that its use is contraindicated for people with kidney failure or awaiting a liver transplant. This was likely in part done in anticipation of the FDA ultimately ordering it to make such a change.
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