Gadolinium MRA

In November 2009, the label of OptiMARK was modified to include a contraindication for people with severe kidney impairment. Educational materials for OptiMARK were also updated to help physicians make informed decisions regarding the appropriate use of the agent. The label modification followed news from the FDA that its review of gadolinium contrast dyes had revealed that OptiMARK, along with Omniscan and Magnevist, carried a higher risk of NSF than others.

Though the FDA’s drug safety unit said …

Dying for an MRI – 7 News Investigation (WSVN 7 Fox News Miami/Fort Lauderdale)

Parker Waichman Alonso LLP Files Suit Against Bayer-Schering on Behalf of Woman Who Developed Nephrogenic Systemic Fibrosis (NSF) from Contrast Agent Magnevist

n May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety warning – on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored …

In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes. At that time, the FDA said it had received 90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time …

In June 2006, the Food & Drug Administration (FDA) issued what would be the first of three warnings on gadolinium contrast dyes. Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. Although these …