FDA Finds Greater Risk of Fatal Disorder From Certain MRI Drugs With Gadolinium

By December 2, 2009Dangerous Drugs

Carey, Danis & Lowe filed a lawsuit in November alleging that a client developed a life-threatening disease after being given certain drugs in support of an MRI test. So our pharmaceutical liability attorneys were extremely pleased to see a report just a few days later that the FDA has also been investigating this class of drugs — and that it found a greater risk with one drug our client was given. According to a Nov. 25 article from Reuters, an FDA memo released the day before Thanksgiving showed that MRI contrast agents made by GE Healthcare, Bayer AG and Covidien raise patients’ risk, even compared to other manufacturers’ versions of similar MRI imaging contrast agents made with gadolinium. The agents are injected into patients undergoing MRIs to help doctors see the resulting images better.
The entire class of imaging contrast agents already carries a black box warning disclosing that they increase risk of nephrogenic systemic fibrosis in patients with kidney problems. NSF is a disease that builds up collagen in the skin, eyes, joints and internal organs. The hardening of the skin and contracture of the joints can leave patients disabled by limited movement, physically scarred and with chronic pain. In its memo, the FDA announced that the greatest number of NSF cases were linked to use of GE Healthcare’s Omniscan — the first contrast agent given to our own client. The FDA also found a greater risk for Bayer AG’s Magnevist and Covidien’s Optimark. Its review recommended labels on those products warning of the greater risk. At an already-scheduled meeting Dec. 8, the agency plans to ask an expert panel for advice.
As a dangerous drug lawyer, I am extremely pleased that the FDA is taking aggressive steps to limit kidney patients’ exposure to this toxic substance. In this, our government is just a short step behind the European Medicines Agency, which on Nov. 20 classified gadolinium-containing agents into low-, medium- and high-risk agents for kidney patients based on their chemical content. All three of the agents the FDA found associated with higher numbers of NSF cases are on EMEA’s high-risk list. With so much evidence against these higher-risk agents, I hope the FDA takes steps to end their use entirely, or at least require very strong warnings about the risk to people who have — or may have — kidney problems. Otherwise, far too many people may suffer preventable but life-altering problems similar to our client’s, which include permanent disability, disfigurement and many thousands of dollars in medical bills.


Based in St. Louis and southern Illinois, the Lowe Law Firm represents people throughout the United States who suffered similar injuries after taking a drug they thought would help. All manufacturers are required to offer only products that are safe and free of defects, and pharmaceutical companies are not an exception. Nonetheless, the FDA issues recalls and safety warnings for numerous prescription and over-the-counter drugs, including drugs whose manufacturers misled consumers or withheld vital safety information. Our defective medication attorneys help patients who were hurt as a result of unethical behavior and serious safety defects in pharmaceuticals hold the drug company legally responsible. In an individual or class-action lawsuit, you can claim compensation for your illness or injury, including pain, emotional suffering and any permanent disability or death, as well as every penny you spent because of the defective drug.
If you or a loved one was hurt by taking a prescription drug that was supposed to help, don’t hesitate to call the Lowe Law Firm. We offer free, confidential consultations, so there’s no risk in speaking to us about your rights and your legal options. To set one up, please contact us through our Web site or call toll-free at 1-877-678-3400 today.