Omniscan – the Most Dangerous Gadolinium-Based Contrast AgentOmniscan has the dubious distinction of being the contrast agent that has caused the most cases of Nephrogenic Systemic Fibrosis (NSF). Omniscan is the brand name for the gadolinium-based contrast agent manufactured by GE Healthcare. Omniscan’s generic name is gadodiamide, and it is sometimes referred to in medical records as Gd-DTPA-BMA. Omniscan was approved by the FDA in 1993, and first introduced to the U.S. market that year. However, the FDA now recognizes that Omniscan is one of three gadolinium-based contrast agents (GBCAs) most likely to cause NSF.
Omniscan is over 1000 times less stable than its main competitor, Magnevist. In an effort to compensate for this, Omniscan contains 25-50 times as much chelate as Magnevist or Prohance. Additionally, Omniscan’s molecular structure makes it less stable. It has a linear non-ionic molecular structure. This is far less stable than a macrocyclic molecular structure, which is used in the safer contrast agent brand, Prohance.
On September 9, 2010, the FDA announced that Omniscan'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 Omniscan, 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.
More gadolinium lawsuits (MRI lawsuits) have been filed against GE Healthcare than any other manufacturer because Omniscan has caused the largest number of NSF cases.
|