Was the 2007 black box warning accurate?
That’s the question federal regulators need to answer. In 2007, the FDA issued a blanket warning on gadolinium products which said that there was an “undeniable and strong association” between the products and the NSF/NFD injuries. The blanket warning affected some of the following manufacturers and their products: • Bayer HealthCare Pharmaceuticals – Magnevist • Bracco Diagnostics Products – Prohance and Multihance • GE Healthcare – Omniscan • Tyco Healthcare – Optimark At the time, the FDA provided the blanket warning because it did not have enough data on specific products. However, FDA doctors have alleged that GE Healthcare’s Omniscan may present a greater risk of injury in patients with kidney impairments – and the December meeting will determine whether any changes need to be made to the existing black box warning. Hundreds of gadolinium lawsuits filed against manufacturers Several hundred product liability lawsuits have been filed against gadolinium manufacturers alleging that
