Omniscan by GE Healthcare
Omniscan is the brand name of a contrasting agent manufactured by GE Healthcare. Omniscan contains gadodiamide and is used in MRI scans to help doctors find abnormalities in tissue, including abscesses and malignant and nonmalignant tumors. GE Healthcare has promoted Omniscan as one of the leading MRI contrast agents, one that delivers rapid results and high-dose indication. The product was introduced in 1993 and eventually gained approval for high-dose CNS indications, pediatric CNS and body indications, and adult scans. Omniscan even comes in a needle-free version, the first contrast agent of its kind to be approved by the FDA.
The FDA has confirmed that gadolinium contrast agents may put patients at risk for nephrogenic systemic fibrosis (NSF), especially in cases where a patient has kidney problems. GE Healthcare has announced that any patients with kidney problems should not be given Omniscan or similar contrast agents. Omniscan has also been found in clinical trials to sometimes cause adverse side effects, including headache, dizziness, and nausea. In patients with asthma, respiratory problems or hypersensitivity, Omniscan may cause cardiovascular reactions or other adverse reactions.
GE Healthcare has been advised of 96 cases of Nephrogenic Systemic Fibrosis /Nephrogenic Fibrosing Dermopathy (NSF/NFD) following use of contrasting agents such as Omniscan. These illnesses have occurred in the United States, Europe and Asia. A number of lawsuits have been directed at GE Healthcare as a result of NSF. Most notably, former nurse Greta Carolus filed a lawsuit in U.S. District Court against General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation. She alleged that she developed NSF within days of getting a scan that used Omniscan as a contrasting agent. Her suit is believed to be the first aimed specifically at GE Healthcare and Omniscan.