Contrast shortage update: FDA opens door for U.S. providers to order foreign-labeled Bayer contrast media

The U.S. Food and Drug Administration has granted Bayer permission to import foreign-labeled Ultravist (iopromide) to help temper the ongoing impact of the iodinated contrast media shortage. 

Per Bayer’s communications, the contrast agent is manufactured at the same site in Berlin, Germany as the Ultravist that is intended for U.S. markets, but due to its intended distribution abroad it lacks current FDA-approved labeling. 

“In response to iodinated contrast media shortages, due to supply pressures resulting from COVID-19 lockdowns in China, Bayer has engaged with the United States Food and Drug Administration to import and distribute a limited quantity of Ultravist® (iopromide) stock which was originally intended and labeled for foreign markets.” 

This is just one of many mitigation measures that suppliers and imaging organizations have deployed in an attempt to lessen the ramifications caused by the contrast media shortage. When news broke that GE’s Shanghai manufacturing facility had been temporarily shut down in the spring, GE—the United States’ largest supplier of iodinated contrast—indicated that the matter would resolve by late June. But now more than halfway through July, many organizations have a less optimistic outlook, with some indicating the potential for the supply shortage to linger until late September.