FDA Review Prompts Label Changes to Gadolinium Dyes
The Food and Drug Administration (FDA) has taken the decision to require manufacturers of gadolinium-based contrast agents (GBCAs) to update their drug labels. The FDA wants the manufacturers of GBCAs such as Magnevist, Omniscan, and Optimark to take extra measures to ensure that patients with impaired kidney function are adequately warned about their increased risk of contracting nephrogenic systemic fibrosis (NSF).
NSF is a potentially fatal condition where excessive connective tissue forms in the skin and internal organs. Oftentimes those suffering from NSF will experience a painful hardening of the skin, which in some cases can prevent the full use of the legs, feet, arms and hands.
In 2006, the FDA issued a warning about a growing number of cases of NSF reported in patients with kidney dysfunction who received GBCAs as part of diagnostic procedures involving magnetic resonance imaging (MRI) scans or magnetic resonance angiographs (MRA). In 2007, the agency ordered drug companies, including the likes of GE Healthcare, to add enhanced warnings to labels of their GBCA drugs.
This recent announcement by the FDA is of particular interest to attorney Peter W. Burg “I welcome this announcement by the FDA, but for some individuaks it has come as too little too late. Myself and the other dangerous drug attorneys at Burg Simpson remain at the forefront of national litigation regarding NSF, representing more than 150 individuals who have allegedly contracted condition as a result of their exposure to gadolinium-based contrast agents.”
For more information on NSF, its symptoms and the current lawsuit, please call toll free 1-888.895.2080 or visit www.nsflawyers.com
