Last year, the Food and Drug Administration (FDA) mandated black label warnings for gadolinium-based contrast agents (GBCAs). The FDA has now issued a more specific warning to further emphasize the risk for nephrogenic systemic fibrosis (NSF) to patients with kidney diseases.

In particular, the FDA’s warning cites Magnevist, Omniscan, and Optimark brands of GBCA as inappropriate for use in patients with acute kidney injury or chronic severe kidney disease. This is due to an FDA risk review of those brands.

However, the FDA also said in its press statement that it continues to assess other brands also.

As a result, the FDA is revising the black label warning on all brands of GBCA, now emphasizing screening patients for kidney dysfunction before administration.

As part of the warning, the FDA has offered new GBCA guidelines for imaging facilities.

For more information, view this FDA announcement.