FDA Requiring New Warnings on Gadolinium-based Contrast Agents

 

On September 9, 2010 the Food and Drug Administration (FDA) announced that it will require warnings on gadolinium-based contrast agents (GBCAs), used in magnetic resonance imaging MRI and magnetic resonance angiography MRA, in an attempt to minimize the risk of patients developing Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD).

The Danger of Gadolinium-based Contrast Agents

NSF/NFD is a painful and debilitating health condition that can be fatal. It involves hardening of the skin and other tissues and can affect internal organs. It is a very rare condition. Patients with impaired kidney function have developed NSF/NFD after using GBCAs.

The New Warnings

The new warnings advice health care professionals that they must screen patients for impaired kidney function before administering a GBCA. It advises them not to use them in patients who have impaired kidney function unless the test is absolutely necessary and if there is no alternative method for imaging. Patients with impaired kidney function who do receive the drug must be closely monitored for signs of NSF/NFD.

The New Warnings and Responsibility for GBCA Injuries

Pharmaceutical injury lawsuits often involve defective products, medical malpractice, or both. The three brands of GBCA are Magnevist, Omniscan, and Optimark. All three are dangerous drugs, meaning that when patients are harmed by their use they may be entitled to compensation through a defective product lawsuit.

These new warnings place specific responsibilities on doctors to use extreme care when considering GBCAs for their patients and to thoroughly screen those patients for an elevated risk of the adverse side effect. This clearly indicates that doctors who fail to heed the warnings can be held responsible for medical malpractice when their patients develop NSF/NFD after the use of GBCAs.

If you or a loved one has developed the symptoms of NSF/NFD after undergoing MRI or MRA, an experienced pharmaceutical injury attorney can help you get the compensation that you need and deserve.