FDA committees will discuss the possible link between gadolinium-based contrast agents and nephrogenic systemic fibrosis (NSF).
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet on December 8 to review data from gadolinium contrast manufacturers.
The ultimate goal is to provide the FDA with recommendations to minimize the NSF risk, differentiate the risk of NSF between contrast products, and give guidance on labeling and other risk-reduction methods.
Two years ago, an apparent rise in the number of NSF cases prompted the FDA to request gadolinium contrast manufacturers to include a black box warning on their product labels about the potential for NSF.
At that time, the label read: “The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents.”
Over the past two years, additional clinical data have been accumulated, and next month, the manufacturers have a maximum of 20 minutes each to present evidence on behalf of their products.