Report: GE ignored Omniscan warnings

Apr 18, 2010

Documents from the Circuit Court of Cook County in Chicago allege that GE Healthcare of Chalfont St. Giles, U.K., declined to restrict the use of its gadolinium-based MRI contrast agent Omniscan, despite warnings from people inside the company.

An April 15 report from ProPublica stated that GE bypassed the advice of its own pharmaceutical safety officials to restrict use of Omniscan, despite reports from Europe that the agent was linked to nephrogenic systemic fibrosis (NSF).

In an e-mail response to AuntMinnie.com, GE spokesman Conor McKechnie said the report is "an incomplete and gross mischaracterization of GE's actions" and "omits key facts."

The publication cites a court document in the case of Robbie Booker vs. GE, one of some 500 lawsuits filed against GE regarding Omniscan. Booker stated that she had suffered from end-stage renal disease since November 1999 and received Omniscan 11 times from 2001 to 2007 during MRI procedures. In October 2007, she was diagnosed with NSF.

The document also notes a May 2006 meeting convened by GE's vice president for drug safety. Instead of alerting doctors to stop using Omniscan in high-risk patients, the report claims that GE spent the next year asserting that a warning was unnecessary.

It wasn't until September 2007, the report continues, that GE and manufacturers of other gadolinium-based MRI contrast agents revised their labels to warn patients and users of the NSF risk.

In his e-mail to AuntMinnie.com, McKechnie wrote that the report "casts GE in a false and negative light, as it omits key facts, despite our consistent engagement over several months to explain a complex issue difficult to capture in a short article."

He added that the company "moved quickly, proactively, and responsibly in collaboration with health authorities to advise healthcare practitioners about the potential risk of using gadolinium-based contrast agents in renally impaired patients."

Because GE proactively advised healthcare practitioners of the potential risk, McKechnie added, there have been no new NSF cases reported to GE and "plausibly associated with the administration of Omniscan with a documented date of onset after September 2007."

Relative to the May 2006 meeting referenced in the article, McKechnie said GE Healthcare's Medical Diagnostics division recommended consideration of a temporary restriction on the use of Omniscan in at-risk patients until more information was known.

After meeting in May 2006 with GE, the Danish Medicines Agency (DMA) chose to "warn the medical community of the potential but yet unknown risks through a Web site alert. Because of the limited medical and scientific information available at that time, the DMA did not restrict the use of Omniscan in renally impaired patients in Denmark," the e-mail noted. "The DMA also stated its intention to request that other contrast agent manufacturers review their pharmacovigilance data for any reports of NSF associated with their respective products."

McKechnie said GE Healthcare also prepared a global safety alert to regulatory agencies worldwide on May 9, 2006, and distributed a letter to healthcare providers globally, advising them of NSF reports following Omniscan administration in both Denmark and Austria.

This letter was reviewed by the U.S. Food and Drug Administration (FDA) and sent to GE customers in the U.S. on June 6, 2006.

McKechnie asserted that the ProPublica article "inaccurately suggests the letter was intended to convince radiologists that Omniscan was not proven to cause NSF. This is not true. The letter alerted doctors of a potential but newly identified risk and, combined with the FDA's public health alert, put the medical community on notice that a potential risk existed," the e-mail stated.

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