FDA Request For The Addition Of Boxed Warnings About NSF. Parker Waichman LLP recently learned that the Federal Drug Administration (FDA) has notified healthcare professionals of the Agency’s request for the addition of boxed warnings and new warnings about the risk of Nephrogenic Systemic Fibrosis (NSF) for all Gadolinium based contrast agents. The new warnings require highlights, describing the risk for NSF following exposure to Gadolinium in patients with acute or chronic severe renal insufficiency. The FDA is also requesting the addition of a boxed warning about the risk for NSF.
If you or a loved one believes that you may have sustained Nephrogenic Systemic Fibrosis (NSF), also referred to as Nephrogenic Fibrosining Dermopathy (NFD), please contact our office by visiting www.yourlawyer.com/topics/overview/nsf . Free case evaluations are also available by calling Parker Waichman LLP at 1-800-YOURLAWYER (1-800-968-7529).
In 2006, researchers found there is a direct connection between the development of Nephrogenic Systemic Fibrosis (NSF) and the use of Gadolinium contrast agents during Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) for those kidney problems.
An MRI scan is performed to obtain a clear detailed image of a patient’s internal organs and tissues and an MRA is used to obtain a detailed image of a patient’s blood vessels. During some MRI and MRA scans, a Gadolinium based contrast agent is injected into the patient to highlight blood vessels so they can be distinguished from other nearby tissues.
Symptoms of Nephrogenic Systemic Fibrosis
Symptoms of Nephrogenic Systemic Fibrosis (NSF) are.
- Hardening and tightening of the skin
- Red or dark patches on the skin
- Yellow spots on the whites of the eyes
- Stiffness in joints and trouble moving or straightening the arms, hands, legs, feet
- Pain deep in the hip bones or ribs
- Muscle weakness
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