Covidien’s Optimart and General Electric’s Omniscan Considered Risky

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Thickening of the skin, organs and other tissues, broken bones, and difficulty moving the body are associated with a potentially fatal skin disease called nephrogenic systemic fibrosis (NSF).  Some gadolinium contrast dyes used for MRI scans could be the cause, according to a Food & Drug Administration (FDA) advisory panel.

Finally, the FDA is taking a stance on current data revealing that Covidien’s Optimart and General Electric’s Omniscan are risky for patients with severe kidney disease.  These products already carry a black box warning alerting doctors to avoid using them for those patients unless absolutely necessary.  Millions of people have been given these drugs to make MRI scans easier to read.

Some panelists recommended Bayer’s Magnevist, the most widely used of gadolinium-based contrast agents raking in $354 million in sales last year, be included in the high risk group.  However, Dr. Lawrence Hunsicker, a kidney specialist at the University of Iowa Hospital and Clinics, said there was “less consensus” on that particular drug.

This is puzzling since the FDA has received hundreds of NSF reports in patients injected with mainly Magnevist and Omniscan.  Is it possible that some of the panelists could have a vested interest in Bayer?  Dr. Hunsicker stated, “We already have a black box warning that as far as we can see has taken care of the problem.”

General Electric vowed to cooperate with the FDA to “determine the best path forward” although their head of Healthcare’s medical professional services told the panel the idea that some GBCAs have a higher NSF risk than others “remains unproven” and labeling them differently could create “a misconception of one agent being inherently safer than another,” according to a Reuters article.  Omniscan’s global sales peaked $80 million in 2008.

The FDA said competitors Bracco Diagostics’ Prohance and Multihance appear linked to the lowest risk.  The agency also said it was too early to decide about Bayer’s Eovist and Lantheus Medical Imaging’s Ablavar, which were recently approved

As usual, these targeted companies prioritize profits over safety.  Victims suffering from burning, itching, hard skin with dark patches, and severe hip and joint pain, are reminded of that each painful day.