Covidien Plc (COV) stated that it will voluntarily contraindicate the use of its Optimark gadoversetamide injection, a gadolinium-based contrast agent or GBCA, in magnetic resonance imaging or MRI procedures involving patients with severe renal impairment. The company said it is modifying the product's label to reflect a contraindication for this small patient population, which constitutes less than 0.5% of the U.S. population.
Mallinckrodt Inc., a Covidien company, submitted this label change to the U.S. Food and Drug Administration (FDA) and is implementing the new label in the U.S. effective immediately. The company added that it is implementing this label change in all other countries, where Optimark contrast agent has been approved for sale, in accordance with local regulatory requirements.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.