Bracco Diagnostic’s Multihance May Cause Injury

Multihance, a contrast agent, or dye, used in MRIs (magnetic resonance imaging )and MRAs (magnetic resonance angiography), has been listed in a Food and Drug Administration (FDA) warning as being linked to a crippling disease called NSF/NFD (nephrogenic systemic fibrosis / nephrogenic fibrosing dermopathy).

What’s happening

Manufactured by Bracco Diagnostics, Multihance is a gadolinium based dye used in MRIs and MRAs that distinguishes between abnormal and normal tissues in the body. In the majority of cases, the gadolinium is safely excreted from the body shortly after the testing is completed. However, for some patients with renal disease (a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes), the dye does not leave the body and causes havoc with the person’s skin and organs.

NSF/NFD defined

According to the FDA, NSF/NFD was first identified in 1997 and has occurred in patients with moderate to end-stage renal disease. Patients with this condition develop fibrosis of the skin and connective tissues throughout the body. The skin thickening may inhibit flexion and extension of joints resulting in contractures.

A contracture develops when the normally elastic (stretchy) connective tissues are replaced by inelastic (non-stretchy) fiber-like tissue. This makes it hard to stretch the area and prevents normal movement. Contractures occur primarily in the skin, underlying tissues, muscle, tendons, and joint areas.

In addition, patients may develop widespread fibrosis (excessive molecule deposits) of other organs. The disease is progressive and may be fatal. Unfortunately, its exact cause and a cure are currently unknown.

Related products

Multihance is not the only product that is being investigated by the FDA. Four others are also being investigated for possibly causing NSF/NFD. They are:

  • Omniscan, manufactured by GE Healthcare, a division of General Electric
  • Optimark, manufactured by Mallinckrodt, a division of Tyco Healthcare
  • Magnevist, manufactured by Berlex Imaging, a division of Bayer Healthcare
  • Prohance, also manufactured by Bracco Diagnostics

Despite the investigation and warnings, all of these products continue to be marketed and used.

Symptoms of NSF/NFD

According to the Food and Drug Administration (FDA), there are several symptoms that accompany NSF/NFD, including:

  • For the bones, joints and muscles: joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness
  • For the eyes: yellow raised spots on the whites of the eyes
  • For the skin: burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening

The FDA has recommended having a skin biopsy to anyone who feels that they may have NSF/NFD or to undergo dialysis. To view the FDA’s comments, see their website at www.fda.org/.

Seek help as soon as possible

It’s important to get medical help as soon as possible as there is still little known about this disease. It’s also important to contact an attorney to see if you have a case against the manufacturer. To contact an attorney in your area, click here.

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