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After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe
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The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States. A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.
Although Bayer's application for Gadovist is new, Gadovist itself is not. Gadovist has been approved for sale in the European Union since 1998. However, until recently, Bayer has not sought approval for selling it in the United States. This decision -- whatever its basis -- has put Americans at risk.
Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate. In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure. Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure. As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist. The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment. Gadovist does not have this restriction.
A gadolinium-based contrast agent's molecular stability has dire health consequences, especially for people with impaired renal function, like those on dialysis. If a gadolinium-based contrast agent breaks down within the human body, the person is at risk of developing nephrogenic systemic fibrosis (NSF). NSF, also known as nephrogenic fibrosing dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD is the use of gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
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Posted By DeCarli Law on
August 12, 2010 03:30 pm |
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