Four years ago, GE Healthcare experts recommended limiting the use of their gadolinium contrast dye, Omniscan, after it was linked to nephrogenic systemic fibrosis (NSF), reveals ProPublica.

The decision was fueled by European reports that tied Omniscan to a likely crippling disease that is now known as NSF. Meeting details were exposed in a lawsuit’s unsealed order against the company, ProPublica said.

GE eschewed its owns safety experts’ advise for restriction in high risk patients. Instead, they affirmed that Omniscan was as safe as its competitors and argued against an exclusive drug label warning.

Previously sealed evidence indicates that doctors and the U.S. Food & Drug Administration (FDA) had not seen internal company research sparking concern about Omniscan breaking down chemically, releasing the potentially toxic metal gadolinium into the body, said ProPublica.

Plaintiffs’ lawyers attest the May 2006 meeting as critical because many patients were exposed to Omniscan afterward, ProPublica said.

NSF, a debilitating condition, prompts excessive formation of connective tissue in the skin and internal organs. Symptoms are: high blood pressure, burning, itching, swelling and hardening of the skin. Other maladies include muscle weakness, red or dark skin patches, and pain deep in the hip bones or ribs. There is no effective treatment for the disease, which in a progressive state causes severe joint stiffness and sometimes death. Although information is limited, growing evidence indicates that NSF occurs solely in persons with severe kidney disease who have been exposed to a gadolinium contrast dye such as Omniscan.

Since 2007, all gadolinium agents have carried the FDA’s strongest black box safety warning citing the risk of NSF. But last fall, the FDA released a risk assessment that indicated Omniscan, along with dyes OptiMark and Magnevist, posed a higher risk for the disease. The assessment highlighted 382 cases in which Omniscan was deemed the single imaging agent in an NSF report. Magnevist was designated in 195 and OptiMark in 35 reports.

GE Healthcare and Omniscan are named in approximately 500 lawsuits filed by NSF patients. While most are pending in federal court, the unsealed order concerning the May 2006 meeting was issued in Illinois, presided over by Cook County Circuit Judge Deborah Mary Dooling. The Judge said the evidence was sufficient to add a claim of punitive damages, however, the parties reached a confidential settlement before trial.