Gadolinium Litigation and the Rasansky Law Firm

The Rasasnky Law Firm is actively reviewing possible Gadolinium Litigation in light of recent announcements regarding Gadolinium by the Food and Drug Administration, or FDA.

FDA: Gadolinium Dangers

The FDA recently released a Public Health Advisory regarding contrast agents containing Gadolinium which is used in Magnetic Resonance Imaging, or MRI, and Magnetic Resonance Angiography, or MRA. The FDA has recently linked Gadolinium to a disease known as Nephrogenic Systemic Fibrosis (NSF ) or Nephrogenic Fibrosing Dermopathy (NFD). According to the FDA, a possible link between NSF - NFD and exposure to Gadolinium containing contrast agents has been identified. Gadolinium is a heavy metal which is highly toxic. MRI and MRA contrasting agents that contain Gadolinium are supposed secrete out of the body quickly. The danger seems to lie in people with impaired kidney function who may not be able to secrete the toxic substance as fast as necessary.

NSF - NFD Linked to Gadolinium in MRA's

According to the FDA, there have been 25 cases of NSF - NFD reported in kidney failure patients who had received Gadolinium-containing contrast agent Omniscan while taking an MRA test. The disease has developed in patients receiving as few as one treatment containing the contrasting agent.

The FDA is continuing its investigation into the relationship between Gadolinium and NSF - NFD in Kidney patients. The Rasansky Law Firm is closely following these investigations. If you have received Gadolinium injections and have suffered side effects, contact the Gadolinium lawyers at the Rasansky Law Firm as soon as possible so we can keep you up to date with the situation.

FDA: Gadolinium Approved for MRI, Not Approved for MRA

According to the FDA, Gadolinium, which is sold under the brand names, Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance, is approved for MRI's. None of these have been approved by the FDA for MRA's. Also, during an MRA, the dosage of Gadolinium is often 3 times the FDA approved dose for an MRI.

Does Gadolinium Exposure Lead to Nephrogenic Systemic Fibrosis (NSF ) or Nephrogenic Fibrosing Dermopathy (NFD)?

The FDA has not yet determined conclusively that Gadolinium exposure leads to NSF or NFD, but the agency is continuing their investigation of the cases that have been linked to Gadolinium exposure. Currently, the FDA investigation into Gadolinium is focusing on 25 cases of NSF or NFD that have arisen in patients who received the contrasting agent. If you have had an MRI or MRA, and have been exposed to Gadolinium as a contrasting agent, watch for signs of NSF or NFD. If you feel you might be showing symptoms, contact your physician as soon as possible. If you are diagnosed with NSF - NFD related to a Gadolinium exposure, contact the Gadolinium Lawyers at the Rasansky Law Firm as soon as possible.

What is Nephrogenic Systemic Fibrosis (NSF ) or Nephrogenic Fibrosing Dermopathy (NFD)?

Nephrogenic Systemic Fibrosis (NSF ) or Nephrogenic Fibrosing Dermopathy (NFD) is a a serious disease that begins in the skin of the arms and legs before spreading to other parts of the body, including the internal organs. It causes the skin to become stiff and even develop a wood-like texture. NSF - NFD also causes the skin to change color, often to a pink or orange and then brown, and to lose skin pigment. Hair loss is another symptom of NSF - NFD. This is a very painful condition, causing difficulty in moving limbs. The disease can spread to internal organs. Nephrogenic Systemic Fibrosis - Nephrogenic Fibrosing Dermopathy is painful, debilitating and may cause death.

Symptoms of NSF - NFD

Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy have the following symptoms:

Skin sympotms: Burning, itching, swelling, hardening, red patches Body symptoms: Yellow spots on eyes, stiff joints in legs, arms, hands and feet, deep bone pain in hip and ribs, muscle weakness, hypertension preceding skin lesions

Symptoms of NSF - NFD may take as long as 18 months to develop after exposure to Gadolinium contrasting agents. If you have been exposed to Gadolinium, it's important you watch closely for any symptoms of NSF - NFD. If you are unsure whether problems you are experiencing are related to the Gadolinium exposure, contact your physician as soon as possible.

Treatment of NSF - NFD

There is, unfortunately, no currently available treatment for NSF - NFD.

FDA Gadolinium Warning

The FDA requested a warning be placed on Gadolinium containing contrasting agents stating that patients with kidney impairment who receive Gadolinium based contrasting are at risk of developing NSF - NFD. The FDA goes on to advise that recent recipients of liver transplants or those with liver impairment are also at risk of developing NSF if exposed to Gadolinium based contrasting agents.

Manufacturers of Gadolinium Based Contrast Agents

Magnevist: Bayer Schering Pharma, Berlin, Germany

Omniscan: GE Healthcare, Chalfont St. Giles, U.K.

OptiMARK: Mallinckrodt, Inc., Hazelwood, Mo.

ProHance and Multihance: Bracco Diagnostics Inc., Princeton, N.J.

Possible Gadolinium Litigation

If you or a loved one has been exposed to Gadolinium (known as Omniscan, Magnevist, MultiHance, OptiMARK and ProHance) used as a contrasting agent during an MRI or MRA, and subsequently were diagnosed with NFS - NFD, contact our Gadolinium lawyers as soon as possible. At the Rasansky Law Firm, we will evaluate your case, and make sure your rights are protected. If Gadolinium litigation becomes necessary, we will vigorously pursue your case to help you protect your rights.

Symptoms of NSF/NFD include

-Burning of the skin

–Hardening or tightening of the skin

–Swelling in extremities

–Red or dark patches on the skin

–Yellow spots on the whites of the eyes

-Difficulty moving hands, feet or legs

- Joint pain or stiffness in joints

–Muscle weakness

On May 23, the FDA required a Black Box Warning on all MRI contrast dyes containing gadolinium, warning caution in using them in people with impaired kidney function