Regulatory Focus™ > News Articles > FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

Posted 17 July 2012 | By

The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA).

In an 18 July posting in the Federal Register, FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue to form in a person's internal or external organs.

"Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of GBCA and degree of renal impairment at the time of exposure; imaging patients with severe renal failure appear to be at highest risk" wrote FDA.

The data indicating association between GBCAs and NSF are inconsistent and are "not fully understood" by regulators, notes FDA.

However, given the possibility of severe and potentially fatal side effects, FDA said there is a "public health need to study the risk of NSF associated with the exposure of those remaining marketed GBCAs and to inform the development of reliable knowledge, practice guidelines and regulatory processes in relationship to the safety of these agents."

FDA Seeks to Build Patient Registry

Perhaps borrowing from private disease-centric foundations, which have long used patient registries as a way to drive the development of both disease knowledge and new products, FDA said it is interesting in harnessing an existing Quality Assurance registry of patients with renal failure who received GBCAs.

"Patients already enrolled in this QA registry will be invited to enroll in an outpatient registry to study their risk of NSF," FDA explained. "Data from this project will help understand the effect of cumulative dosing of the GBCAs in patients with slow deterioration of renal function as occurs with aging, and the data might also provide further reassurance as to the safety of the GBCAs identified as having minimal association with the risk of NSF by prospectively following patients who have received GBCAs."

The new outpatient registry would be funded with $250,000 in FDA grant money in 2012, with additional years of funding subject to performance evaluations and the availability of funding.

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