In 2006, the Food and Drug Administration (FDA) determined that a specific dye used in magnetic resonance imaging (MRI) could cause serious complications. Patients who received gadolinium-based contrasting agents (GBCAs) were at risk for developing potentially fatal conditions affecting the kidneys.
If you or a loved one received an MRI or magnetic resonance angiography (MRA) using a gadolinium-based contrasting agent and complications developed, you may have a claim for compensation. An experienced dangerous drug attorney at Roberts & Roberts can help you to pursue a claim for damages.
Gadolinium in MRIs and MRAs
An MRI is a medical imaging technique that uses powerful magnets and pulses of radio-wave energy to take pictures of the inside of the body, including the organs. An MRA is a special type of MRI that is used to specifically study blood vessels to aid in the detection of vascular diseases, heart disorders and strokes.
There are five primary gadolinium-based contrasting agents approved by the FDA, including Magnevist, MultiHance, Omniscan, OptiMARKand ProHance. These and other GBCAs are manufactured by using a chelating process, which involves the use of large organic molecules to form a stable complex around the gadolinium ion. The stable complex reduces the potential risk of toxicity from exposure to gadolinium, and the complex is removed from the body through the kidneys.When a patient undergoes an MRI or MRA, contrasting dyes may be used to provide a clearer and more detailed picture of internal organs or blood vessels. Many of the contrasting dyes contain a paramagnetic metal ion called gadolinium. Paramagnetic ions move differently within magnetic fields, thus providing improved images of body organs and tissues.
Unfortunately, GBCAs can cause a potentially fatal condition called nephrogenic systemic fibrosis (NSF) to occur. This condition can lead to kidney failure and renal disease, among other potential problems and side effects.
Health Risks from Gadolinium and GBCAs
The first cases of NSF were reported in 1997, but the incidents were unpublished for approximately three years after the first patients developed the condition. However, as more reports of this potentially fatal disease began to occur, the FDA eventually linked NSF to gadolinium dyes.
The first potential association between GBCAs and NSF was reported in April 2006 in an article in a journal called Nephrology Dialysis Transplantation. In May 2006, a link was also discussed in a report from the Danish Medicines Agency. With these studies, as well as other reports of NSF, the FDA launched an investigation into the risks of GBCAs and kidney problems in December 2006.
In light of the clear evidence that GBCAs can cause nephrogenic systemic fibrosis, the FDA now requires the manufacturers of all five of the contrasting dyes to include both a new warnings section on their labels and to include a boxed warning alerting patients and physicians of the risk of developing NSF.
Consequences of Nephrogenic Systemic Fibrosis & GBCAS
Patients who experience complications associated with gadolinium may experience:
Those who develop NSF may become paralyzed and wheelchair-bound due to the joint problems they experience and because of the skin-tightening that limits their range of motion. In some cases, the internal organs and diaphragm can be affected by NSF complications, resulting in a patient being strangled from the inside out. Patients may also experience kidney failure and renal disease. Many of these side effects can be fatal.
Unfortunately, there is no treatment for NSF, and patients who develop the condition may not recover.
Taking Legal Action Due to Gadolinium Injuries
If you or a loved one has developed NSF after receiving an MRI or MRA, you may have a claim for damages against the manufacturer of the GBCA that was used in your medical testing.
An experienced dangerous drug lawyer at Roberts & Roberts understands what you are going through and can take action to protect your legal rights. Contact Roberts & Roberts today at 903-597-6000 or use our online form to schedule a free consultation and learn how we can help you to take action.