FDA Should Tighten Restrictions on Omniscan, OptiMark, Panel Says

A panel of medical experts reviewing gadolinium contrast dyes recommended last week that the labeling for General Electric’s Omniscan and Covidien’s OptiMark should have stronger warnings regarding their risk of <"http://www.yourlawyer.com/topics/overview/nsf">nephrogenic systemic fibrosis (NSF). According to an article on Propublica.com, most panel members felt the Food & Drug Administration (FDA) should basically ban the use of Omniscan and OptiMark in patients with severe kidney disease.

The recommendation came after the advisory panel reviewed data that indicated Omniscan, OptiMark and Bayer’s Magnevist carried a higher risk of NSF than other gadolinium dyes currently on the market. Though some panel members pushed for similar labeling changes for Magnevist, the members were unable to reach consensus on that issue. The panel did not take a formal vote, but an FDA official said its recommendation on Omniscan and OptiMark represented a “preponderance” of opinion among the members.

Dr. Dr. Sidney Wolfe, a panel member and head of Public Citizen’s Health Research Group, was among those pushing for stronger warnings on Omniscan and OptiMark. According to Reuters, Dr. Wolfe expressed concerns that leaving the same warning on all the drugs “may cause more problems than if you distinguish between the drugs as best as you can.”

According to ProPublica, following the daylong advisory panel meeting, officials from the FDA said they would take the recommendations under consideration when deciding on what, if any, steps to take in regards to Omniscan, OptiMark and other gadolinium agents used in MRI and MRA procedures.

Since 2007, all gadolinium agents have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF. But earlier this fall, the agency released a risk assessment that indicated that Omniscan, OptiMark and Magnevist carried a higher risk of the debilitating, and often fatal, disease. The assessment cited 382 cases in which Omniscan was named as the single imaging agent in an NSF report. Magnevist was named in 195 reports and OptiMark in 35. The FDA put Omniscan’s market share from 2005 through 2007 at only 32%, compared with 49% for Magnevist and 10% for OptiMark.

According to ProPublica, one particular riveting portion of last week’s advisory panel meeting involved testimony from SF patient from North Carolina. She described in detail the “torture” she has experienced since contracting NSF after undergoing an MRI in 2006. The disease initially presented as swelling in her ankles migrated up through her organs and body. The woman, who is confined to a wheelchair, told the panel that today, her bones now feel as though they are “in a vise,” ProPublica said.

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dye.

Last month, following the release of the FDA risk assessment, Covidien announced it would be changing the OptiMark label to contraindicate its use in patients with severe kidney disease.

Omniscan, OptiMark and Magnevist have already been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the gadolinium-based MRI contrast dyes. Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio.

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