FDA MRI Contrast Gadolinium Warnings
Gadolinium is an element that is used in a number of manufacturing processes and also in dyes that are used in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In May 2007, the Food and Drug Administration (FDA) issued a warning about possible Gadolinium side effects possible with MRI and MRA contrast agents. Specifically, the FDA warned that potential Gadolinium side effects include nephrogenic systemic fibrosis, or NSF. Kidney patients who have had MRI and MRA scans are particularly vulnerable to this largely preventable and potentially fatal disease.
Some medial professionals inject patients with Gadolinium MRI dyes before patients have an MRI or MRA scan. The dyes improve the medical images of any abnormal tissue, which some physicians claim helps make diagnosis easier and more precise. The dyes do not pose much of a threat to patients with healthy kidneys – these patients simply have the Gadolinium flushed through their kidneys easily and quickly.
Patients with kidney problems, however, have bodies that struggle to get rid of the Gadolinium. As a result of this, these patients face a higher-than-normal risk of NSF. NSF is quite rare and affects the muscles, skin, and eventually the organs. Patients with NSF often experience a tightening and thickening of the skin, diaphragm, lungs, muscles, and other body systems.
Patients with NSF experience many symptoms, including joint inflexibility, muscle weakness, patches or dark or reddish skin, yellow spots on the whites of the eyes, skin that appears or feels hardened or puckered, burning, itching, swelling, hip pain, and rib pain.
The FDA reports that it can take months for NSF to develop after a patient has been exposed to Gadolinium through an MRI or MRA dye injection. The agency does report that there have been deaths reported that have been linked to NSF complications. More than 90 patients have reported developing NSF after having an MRA or MRI with Gadolinium contrast dyes, according to the FDA.
The FDA is recommending that patients with moderate or serious kidney disease avoid getting an MRA or MRI with Gadolinium contrast agents. The agency suggests that physicians use other imaging methods with these patients.
How Gadolinium Enters Body
There are a number of ways that Gadolinium can enter your body. The most common ways include inhalation and injection. If you work in a manufacturing plant or an industry that requires you to handle pure Gadolinium, you may breathe in Gadolinium fumes or particles. There are a number of industries that may use the element. For example, manufacturers of some medical equipment use Gadolinium in their products and some major appliance manufacturers also make use of Gadolinium.
Similarly, researchers and scientists are sometimes exposed to Gadolinium when they do research with the element. In many cases, this sort of exposure to Gadolinium can be prevented simply by wearing proper safety equipment in manufacturing and research processes where Gadolinium is used.
The way that most people are exposed to Gadolinium, however, is when they need an imaging scan such as a magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). Doctors sometimes recommend these scans when they think that there might be something wrong with a patient but traditional diagnostic measures, such as X-rays, fail to detect anything.
In these cases, doctors will sometimes request MRA or MRI scans. During these scans, a patient is injected with Gadolinium MRI contrasting agents, which are Gadolinium compounds or complexes. These agents contain Gadolinium that has been coated with organic molecules in order to minimize the patient’s exposure to Gadolinium and therefore reduce the possibility of Gadolinium side effects. Contrasting compounds made with Gadolinium enter your body just like any other needle injection – they enter your bloodstream directly. The Gadolinium in Gadolinium MRI contrasting agents gathers in abnormal tissues and makes it very clear which organs and tissues of the patient’s body are experiencing problems or are affected by disease. The idea is that the patient’s kidney’s eventually get rid of the Gadolinium in the system.
In cases where a patient’s kidneys are weakened by kidney disease, however, Gadolinium side effects are possible. In these cases, getting an MRA or MRI with Gadolinium contrasting agents can expose the patient to Gadolinium that cannot be easily flushed out of the system. In these patients, an MRI with Gadolinium agents can expose the patient to Gadolinium side effects.
How Gadolinium Remains In Body
In virtually all cases, Gadolinium is flushed out of the body by the kidneys. However, in people who have kidney problems have kidneys that do not function perfectly, and in these individuals, Gadolinium may remain in the body for longer. People who are experiencing kidney failure, especially, may need magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) scans with gadolinium so that a doctor can diagnose the kidney problem. However, if a patient does have kidney failure, they may have been injected with Gadolinium MRI dyes as part of their imaging scans.
Since Gadolinium stays in the body longer in these individuals, the risks of toxicity from the Gadolinium are greater. In fact, some patients with kidney problems who have undergone MRI or MRA scans have developed nephrogenic systemic fibrosis or NSF. This disease is potentially fatal.
There are five contrast agents with Gadolinium which are used for MRA and MRI scans. These include Omniscan (which is manufactured by GE Healthcare), Optimark (which is manufactured by Mallinckrodt, Inc), Magnevist (which is manufactured by Bayer Schering Pharma), and Multihance and Prohance (both of which are manufactured by Bracco Diagnostics, Inc.). The US Food and Drug Administration (FDA) has approved all five of these contrasting agents for MRI scans. However, none of these agents have been approved by the FDA for MRA scans. Despite this, medical practitioners do use all five contrasting agents for MRA scans, despite the fact that exposure to Gadolinium is two to three times higher in MRA scans than in MRI scans.
To compound the problem, some medial health professionals increase the Gadolinium dose – sometimes doubling it – for routine MRI scans. They do this because larger doses of Gadolinium MRI dyes mean that more of the element accumulates in any abnormal tissue, making diagnosing simpler and imaging scans clearer and easier to read. Unfortunately, in cases where the Gadolinium dosage is higher, the body must work even harder to expel the Gadolinium MRI dyes. In patients with kidney problems, a higher Gadolinium dosage takes even longer to expel, leaving the patient exposed to even greater risks of toxicity and Gadolinium side effects. The FDA and other experts recommend that kidney patients avoid getting any MRA or MRI with Gadolinium MRI dyes in order to prevent Gadolinium side effects.
Who Is Responsible?
While it is easy to point the finger and claim that any one party is responsible for Gadolinium side effects and the risks of nephrogenic systemic fibrosis or NSF that many patients are exposed to as a result of magnetic resonance angiography (MRI) and magnetic resonance angiography (MRA) scans, the reality is that many people can be held responsible:
1) Manufacturers of Gadolinium-based contrasting agents. Some critics allege that pharmaceutical companies manufacturing Gadolinium MRI contrasting agents heavily promote and advertise their products, without emphasizing possible toxicity, Gadolinium side effects, and other problems of their products. Some critics also claim that manufacturers are not doing enough to crack down in incorrect or unapproved use of contrasting agents – for example, the popular use of the agents for MRA rather than just MRI scans.
2) The medical profession. Although Gadolinium MRI contrasting agents are FDA-approved for MRI scans, hospitals and health care professionals routinely use the agents for MRA scans, even though MRA scans require higher doses of Gadolinium. In addition, medial professionals sometimes increase the dosages of Gadolinium in order to get clearer images. When dosages of Gadolinium are increased in an MRI with Gadolinium, the risk of toxicity is greater, especially in patients with kidney disease. In addition, some Gadolinium lawsuits allege that health care professionals are not always clear in providing information about the possible risks of Gadolinium or in providing alternatives for patients who want to avoid Gadolinium exposure.
3) Patients and customers. Some critics claim that patients and customers do not ask enough questions about routine medical work and about Gadolinium in particular. These critics note that if patients made a larger effort to learn about treatments, diagnoses, and risks, they would be in a better position to make good decisions about Gadolinium and other health concerns. Information would allow patients to understand Gadolinium side effects and the possible dangers of an MRI with Gadolinium dyes.
5) Authorities. Some critics claim that the FDA and authorities do not crack down enough on incorrect use of Gadolinium-based contrasting agents and on higher-than-usual doses of Gadolinium in imaging scans.
Previous Cases
Gadolinium is an element that is used in many industries, including the health industry. In the health industry, Gadolinium is used for medical scans, including MRA and MRI scans. The FDA and researchers, however, have found that an MRA or MRA with Gadolinium can produce serious Gadolinium side effects, especially for patients with kidney disease. Most physicians schedule an MRA or MRI with Gadolinium contrast agents. This means that Gadolinium MRI dyes are injected into the patient before the MRI or MRA images are taken. The Gadolinium MRI dyes make certain blood vessels in the body more visible, and this allows doctors to get better images and to make better diagnoses. However, an MRA or MRI with Gadolinium dyes can be dangerous. Any patient can have an allergic reaction or experience Gadolinium side effects from contrasting agents used in medical scanning. Patients with kidney disease, though, are especially vulnerable to Gadolinium side effects. For these patients, an MRA or MRI with Gadolinium dyes can lead to an incurable disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD).
The FDA has reported that about 215 patients worldwide have developed NSF/NFD, many of them seemingly after getting an MRA or MRI with Gadolinium dyes. All the patients had kidney disease before getting medical imaging and in 75 of these patients it was confirmed that they had medical imaging with Gadolinium agents before developing NSF/NFD. Researchers found Gadolinium in skin biopsies of patients who were diagnosed with NSF/NFD. The FDA has also reported that they have been able to confirm 90 cases where patients with kidney disease developed NSF/NFD after being exposed to Gadolinium MRI dyes.
A number of attorneys have started to specialize in Gadolinium cases. In February of 2008, the United States Judicial Panel on Multi-District Litigation transferred all federally filed Gadolinium Contrast Dyes Products Liability Litigation to the Northern District of Ohio. All Gadolinium cases will be heard there by Judge Dan A. Polster. Current and future Gadolinium victims can seek to file Gadolinium claims with experienced Gadolinium attorneys.
How Garrett Can Help
Garrett Law Firm understands the risks of Gadolinium exposure and has the experience to provide the best representation possible for a Gadolinium lawsuit. Contact Garrett Law to discuss your condition and needs.
