Dutch Regulators Blast GE Over Omniscan NSF Case
The Danish Medicines Agency has charged that GE Healthcare violated Dutch law when it failed to promptly and completely inform regulators about a patient who died after developing nephrogenic systemic fibrosis (NSF) following exposure to Omniscan contrast dye .
According to ProPublica , the woman at the center of the Danish case, Birthe Madsen, is believed to be among the first patients to develop NSF after exposure to a gadolinium agent. She had been injected with Omniscan for a magnetic resonance scan in 2002 and gradually became immobilized and died of a lung embolism the following year.
A Danish government insurance agency determined in 2004 that Omniscan caused her immobility and in turn her death, ProPublica said. GE Healthcare received this information, but the company did not immediately report it to the Danish Medicines Agency as required by law. A follow-up also did not mention the insurance agency’s conclusion.