In the face of mounting criticism, the FDA has finally agreed to review its decision to issue the same warnings for all gadolinium MRI contrast drugs about the risk of NSF, or nephrogenic systemic fibrosis. The risk appears to be much higher with use of GE’s Omniscan contrast agent, and the FDA needs to take specific actions to make sure physicians and consumers are aware of this.
The NSF lawyers at Saiontz & Kirk, P.A. have been representing individuals diagnosed with this devastating and life-threatening condition for the past two and a half years. The vast majority of cases investigated and nephrogenic systemic fibrosis lawsuits filed involve the use of the Omniscan contrast agent, despite the 30% market share GE’s product has.
When we first began investigating the gadolinium lawsuits, manufacturers were not adequately warning that individuals with moderate to severe kidney failure could be exposed to this life-threatening disorder that causes a severe hardening and thickening of the skin.
In May 2007, the FDA required all manufacturers to add a “black box” warning about the risk. However, they did not specifically require GE to identify the increased Omniscan NSF risk, despite the fact that the contrast agent was by far the one most commonly associated with reports of nephrogenic systemic fibrosis.
It is important for the medical community to understand that Omniscan does not carry the same risk as other contrast agents, as steps can be taken to avoid exposing individuals to this condition, which does not occur unless gadolinium is introduced into the body.
In Europe, the Danish Medicines Agency has amended their recommendations to specifically indicate that the MRI contrast agent Omniscan should not be used in patients with severe kidney failure and in those who have had, or are awaiting, a liver transplant. For the other gadolinium contrast agents available in the country, doctors are cautioned to only administer them after careful consideration to patients with kidney failure, similar to the current warnings in the U.S. for all of the drugs.
The FDA announced last week that advisory committees will re-examine the warnings at a meeting in December 2009, where many expect that specific regulatory action will be taken to ensure that individuals with weak kidneys do not receive Omniscan. The agency needs to require GE to specifically identify the increased Omniscan NSF risk and contraindicate use of Omniscan for those with potential kidney problems.
OMNISCAN NSF LAWSUIT
The attorneys at Saiontz & Kirk, P.A. are continuing to pursue Omniscan lawsuits against GE Healthcare for individuals who have been diagnosed with nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy (NFD). Potential claims are also being reviewed for individuals who have experienced symptoms of NSF/NFD, such as:
- Burning, itching, swelling of the skin
- Development of "thick skin" or "hard skin" which appears shiny
- Red or dark patches of skin
- Yellow spots on the whites of the eyes
- Stiff joints which cause trouble straightening or moving the limbs
- Deep pain in the hip bones or ribs
- Generalized muscle weakness.
To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.