In 1988, gadolinium was developed for its use in magnetic resonance imaging (MRI). Shortly thereafter, it became the preferred choice for contrast agents in MRIs performed in patients with renal dysfunction. This was due in part to the perception that the agent was safer than other iodinated contrast media (ICM). Gadolinium injections are used as a contrast agent in MRI as their magnetic properties enhance visualization through strategic localization. This improves the clarity and detail of medical imaging for precise diagnosis, particularly for abnormal vascularity in the spine, brain, and surrounding tissues.FDA Issued New Class Warnings for GBCA Retention
The FDA made an announcement on December 19, 2017. In this statement, all gadolinium-based contrast agents (GBCAs) would be subject to a new class warning and additional safety measures. This was in response to concerns about the use of GBCAs for MRIs and the substance remaining in patient bodies for months or years following drug administration. The specific changes required by the FDA to GBCA labeling include a precaution and warning in addition to revisions associated with gadolinium retention in the patient instructions, clinical pharmacology, pregnancy, and adverse effects sections.
There are two types of gadolinium-based contrast agents. This includes macrocyclic and linear, which is determined based on the chemical structure. Macrocyclic GBCAs have less retention and for a shorter duration in comparison to their linear counterparts. The FDA also issued guidance for medical professionals to consider GBCA retention characteristics when choosing an agent for a patient, particularly those who are at a greater risk of retention. These include patients who are children, pregnant women, require several lifetime doses, and have inflammatory conditions.
Gadolinium retention and the only known adverse effect to date is nephrogenic systemic fibrosis. This rare condition has been observed to develop in a limited number of patients with pre-existing renal failure. There has not yet been a clear causal relationship established between gadolinium retention and adverse events. Adverse event reports involving several organ systems have also been brought forward by patients with normal renal function. Medical professionals and patients are urged to file reports for GCBA use and side effects to the MedWatch program of the FDA.How Does Gadolinium Affect the Body?
Gadolinium is a metal that is known to inhibit physiologic processes of the body, including blood coagulation, nerve impulse transmission, and cardiac, skeletal, and smooth muscle contraction. This metal has also been found to inhibit the activity of some kinases and dehydrogenases in addition to specific enzymes. Furthermore, it may induce oxidative stress and inhibit the function of the mitochondria through increasing cytokine expression. It is crucial to ensure the safe administration of gadolinium-based contrast agents to prevent potential harm from free gadolinium ions and toxicity.Possible Side Effects from Gadolinium
While generally considered safe, Gadolinium may lead to various potential side effects with varying degrees of severity. Adverse effects associated with gadolinium-based contrast agents are categorized by idiosyncratic reactions and non-allergic reactions. Mild reactions often occur following the administration of GBCAs, including dizziness, headache, coldness, and pain at the site of injection. The most common symptoms of gadolinium toxicity include pins and needles, muscle fasciculations, bone pain, skin discoloration, skin pain, brain fog, and fatigue.
The most concerning side effect of this contrast agent is nephrogenic systemic fibrosis (NSF). This progressive disorder is characterized by the formation of excessive scar tissue and rigid and thick areas of skin covering the joints. This may lead to severe movement restrictions and affect other areas of the body, such as the lungs and heart. Furthermore, there is no current treatment for nephrogenic systemic fibrosis to reverse the effects of the condition or stop its progression.
For a patient with a history of liver disease, renal failure, kidney disease, or kidney transplant, the technologist or radiologist performing the MRI should be informed before the administration of GBCA. Furthermore, it is encouraged and advisable that patients discuss drug allergies and other issues with the technologist or radiologist before an MRI exam. It is recommended that patients with normal kidney function who have previously reported NSF-like symptoms following an MRI with GBCA enhancement do not receive the contrast agent in future exams.Seeking Compensation in a Drug Product Liability Case
If you suffered harm due to gadolinium toxicity following an MRA or MRI utilizing linear gadolinium-based contrast agents, you may be entitled to financial compensation. The following economic and non-economic damages may be recovered in a drug products liability case:
- Past and future cost of medical treatment
- Past and future loss of earnings
- Loss of consortium
- Pain and suffering
- Punitive damages, if deemed appropriate
Our legal team understands the unique challenges that often arise from drug product liability cases, such as gadolinium toxicity. As such, we are prepared to help you navigate the process. We will work diligently to build the strongest case possible by using our knowledge, skills, and resources.Why Should You Bring a Drug Products Liability Case?
Filing a product liability case for a drug, such as GBCA, may assist an individual and their family in recovering the intangible harm and financial losses associated with the product use and adverse effects. It also provides the claimant the opportunity to advocate for more rigorous testing by pharmaceutical companies for drug testing. Furthermore, it improves patient awareness regarding the potential risks that may be experienced from the administration of the drug for MRI exams for patients with normal kidney function and those with renal dysfunction or other pre-existing conditions.Contact a California Drug Products Liability Lawyer
If you or a family member has suffered harm from gadolinium exposure or toxicity, contact our knowledgeable California drug products liability lawyers today for free, friendly case advice at (916) 921-6400 or (800) 404-5400. Our experienced legal team is available to review your potential case, answer your questions, and go over your options moving forward. When you work with our law office, we will handle your case on contingency, meaning there are no upfront retainers or fees. The costs of legal representation will only be due to the successful resolution of the case.
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