Nephrogenic Systemic Fibrosis

Warnings for patients

At the time of its May 2007 black box warning, the Food and Drug Administration also published these warnings for patients who were at risk for developing NSF. This group includes all patients with a history of kidney failure.

Information for the patient:

Physicians who are considering a GBCA for use in a patient who is at risk for NSF should discuss the following with the patient:
  • The possibility of developing NSF, a debilitating and potentially fatal disease that involves the skin, muscle and internal organs.
  • The signs and symptoms of NSF, which include:
  • For the skin—burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
  • For the eyes—yellow raised spots on the whites of the eyes
  • 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
  • If the patient is receiving hemodialysis: Prompt hemodialysis immediately after administering a GBCA hastens its elimination. However, whether hemodialysis prevents or reduces the risk of NSF is unknown.
  • After receiving a GBCA, those patients known to be at risk for NSF require clinical follow-up and long term monitoring for the disease.

Symptoms of NSF

NSF symptoms may first show up within days of the MRI or MRA, or they may not appear for up to 18 months. NSF symptoms may involve skin changesThey often develop rapidly, increasing over a period of days to several weeks.

Patients with NSF describe swelling and tightening of the skin that occurs most frequently on the hands and/or the feet, but for some patients involves the back, chest, and abdomen. The skin changes may start as reddened or darkened patches, and over time, the skin comes to feel stiff and woody. The texture of thickened skin may look like the peel of an orange. The thickened patches are generally symmetrical, occurring on both right and left sides. The region from ankles to thighs is the most frequently affected, followed by involvement between the wrist and upper arms.

Patients may experience burning, itching, or severe sharp pains in areas of thickened skin, and X-ray examination may show calcifications, calcium deposits in the soft tissue. Some patients describe deep "bone pain" in their hips and ribs.

The skin thickening frequently occurs at joints, and reduces the ability to bend them, so that severely affected patients may be unable to walk, or fully extend their arms and hands. Many NSF patients experience progressive muscle weakness. NSF symptoms may involve ankle or feet swelling such as thisIn approximately 5% of patients, the crippling effects of the disease progress so rapidly that within weeks of onset they are confined to a wheel chair.

Hand and foot swelling has been reported, and some patients have developed yellow spots on or near their eyes. Some patients have experienced rapidly changing blood pressure in advance of the onset of skin thickening.

Although NSF has not been fatal, complications of the disease are extensive, and some are life-threatening. Severe skin thickening at joints have caused such extensive contraction of the joint that patients' balance and ability to walk are compromised. Several patients have died from complications of fractures caused by falls.

CONTACT US

Name
Email
Confirm(Email)
Phone
Address
City
State
Zip
How Can We Help You?
Gadolinium Resource
CASEY GERRY SCHENK FRANCAVILLA BLATT & PENFIELD, LLP
110 Laurel St. • San Diego, CA
619 238-1811