FDA Reviewing Gadolinium Black Box Warning As More NSF/NFD Injuries Are Reported
UPDATED: August 5, 2019
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The U.S. Food & Drug Administration (FDA) is planning to meet in December of 2009 to review its 2007 black box warning on gadolinium contrast dyes used in MRI (magnetic resonance imaging) and MRA (magnetic resonance angiography) as more and more consumers report contracting the debilitating disease known as Nephrogenic Systemic Fibrosis (NFS) / Nephrogenic Fibrosing Dermopathy (NFD).
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 they knew about gadolinium side effects, but failed to warn consumers. As more lawsuits continue to be filed, some manufacturers have begun settling with plaintiffs and gadolinium attorneys say that other manufacturers may begin following suit.
No known cure for NSF/NFD
NSF/NFD is a potentially fatal disease that affects skin and connective tissue. It can cause patients’ skin to thicken to the point that they cannot move and can spread to other parts of the body. The disease itself was only discovered in the late 1990's and scientists have said that there is no known cure to date.
If you've been injured due to gadolinium, contact an experienced gadolinium lawyer to discuss your situation and evaluate your options. You may be entitled to compensation for your injuries.