FDA Announces Black Box Warning on Gadolinium-Based Agents

by Administrator 5. August 2010 06:27
The United States Food and Drug Administration announced that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning.

According to a statement released by the FDA, patients with kidney disease or chronic liver disease are at risk for developing nephrogenic systemic fibrosis when exposed to gadolinium-based contrast agents. Five contrast agents are implicated by the black box warning: Magnevist, Omniscan, OptiMARK, MultiHance, and ProHance.

The FDA has been aware of problems with gadolinium since June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.

If you have developed NSF because of gadolinium-based agents, you may be eligible for compensation. Contact a gadolinium lawyer of Williams Kherkher by calling 800-761-3187.

NSF Linked to Gadolinium

by Administrator 9. July 2010 05:53

Over the past several years, researchers have found a correlation between the development of Nephrogenic Systemic Fibrosis and the increasing use of gadolinium-based MRI contrast agents.

 

Gadolinium, an element of the lanthanide series, is the chief component of virtually all contrast agents administered for magnetic resonance imaging. It has been linked to the development of Nephrogenic Systemic Fibrosis, formerly known as Nephrogenic Fibrosing Dermopathy. Nephrogenic Systemic Fibrosis is a systemic disorder with its most visible effects on the skin. NSF patients experience swelling and tightening of the skin.

 

The skin changes may begin as reddened or darkened patches or papules. Patients may experience burning, itching, or severe sharp pains in areas of involvement. 

 

If you or someone you love has been diagnosed with Nephrogenic Systemic Fibrosis, or NSF, and a gadolinium-based contrast agent used in an MRI scan may be to blame, you may be entitled to compensation for your injuries and suffering. Know your rights and a options, and be sure you are in contact with an experience legal team. If you need advice, contact the gadolinium attorneys of Williams Kherkher at 800-761-3187 today.

Most NFS Cases Linked to 3 MRI Contrast Agents

by Administrator 24. June 2010 02:30

The American College of Radiology has advised doctors to avoid using three specific types of common gadolinium-based contrast agents when administering MRIs. 

 

According to an advisory from the ACR, three common contrast agents -  gadodiamide or Omniscan by GE Healthcare, gadopentetate dimeglumine or Magnevist by Bayer Healthcare Pharmaceuticals, and Gadoversetamide by OptiMARK by Covidien - are linked with a greater number of nephrogenic systemic fibrosis cases. As of December 2009, NSF disease has been documented in 382 patients who received gadodiamide, out of 13 million doses; 195 patients who received gadopentetate dimeglumine, out of 23 million doses; and in 35 patients who received gadoversetamide, out of 4.7 million doses, according to the United States Food and Drug Administration. 

 

Nephrogenic systemic fibrosis is an extremely rare and incurable condition. Richard Cohan, MD, professor of abdominal radiology at the University of Michigan said that of all the patients who receive gadolinium with an MRI "more than 90 percent... will not develop NSF."

 

If you or someone you love has been diagnosed with Nephrogenic Systemic Fibrosis, or NSF, and a gadolinium-based contrast agent used in an MRI scan may be to blame, you may be entitled to compensation for your injuries and suffering. Know your rights and a options, and be sure you are in contact with an experience legal team. If you need advice, contact the gadolinium attorneys of Williams Kherkher at 800-761-3187 today.

Understanding the contrast agent industry

by Administrator 18. June 2010 05:43

Contrast agents, also known as contrast media, are compounds used to increase visibility and clarity in medical scans. They allow physicians to reveal diseases and other maladies without using invasive procedures that, without this increased clarity, would otherwise be undetectable to basic scanning methods.

Major producers of contrast agents include GE Healthcare, Bayer Pharmaceuticals, and Bracco Imaging. They are expected to grow a currently $5.4 billion industry in 2008 to a $7.9 billion industry in 2015. Smaller pharmaceutical producers currently involved in developing the generic market for contrast agents are also increasing the profitability of the overall market. Patents for X-ray and MRI-related contrast agents are due to expire within a few years, opening the possibility for generic market growth.

In the case of contrast agents, different scans require different products. Ultrasound contrast agents are generally regarded as less dangerous, using gas microbubble technologies to clarify their resolution. On the other hand, gadolinium-based agents used in X-ray and MRI scans has been linked to serious complications. These agents have been found to be related to the development of nephrogenic systemic fibrosis, or NSF, especially in patients with kidney problems.

If you have developed NSF because of gadolinium-based agents, you may be eligible for compensation. Contact the gadolinium attorneys of Williams Kherkher by calling 800-761-3187.

NSF Boston suit emerging

by Administrator 11. June 2010 07:41

After a 2007 MRI scan, a 70-year-old dialysis patient is planning to sue a Boston hospital after developing nephrogenic systemic fibrosis, or NSF.

The gadolinium-based agent improves and clarifies MRI scans. However, for patients with kidney issues, namely those on dialysis, the risk of developing NSF is increased to dangerous levels. The Food & Drug Administration has given the scanning agent their black box label, the highest warning the agency issues for potentially dangerous drugs. 

The woman was given the agent to improve her MRI scans at King Edward VII Memorial Hospital and Brighan and Women's Hospital in Boston in 2007. Since then, the woman has contracted the skin disorder. Her husband believes that the hospital staff and doctors should have known not to use gadolinium-based agents, especially considering the FDA's strict warnings especially directed to patients with kidney problems.

The hospital announced that it will try to reconcile grievances between the medical staff and family.

There is currently no cure or successful treatment for NSF.

If you have suffered adverse side-effects due to gadolinium-based agents, you may be eligible for compensation. Contact the nephrogenic systemic fibrosis attorneys of Williams Kherkher by calling 800-761-3187 today to discuss your claim.

New Bayer drug in testing process still carries GBCA problems

by Administrator 4. June 2010 06:21

Bayer HealtCare Pharmaceuticals as announced their results of a recent medical trial of a new GBCA, or gadolinium-based contrast agent.

Gadobutrol, the drug under investigation, has not yet been approved by the Food & Drug Administration, as these trials, said the company, are entirely for the process of developing the new drug.

While the company assured those involved in the process, that no serious adverse effects came from the study and that only about 4% of the patients in the study suffered any adverse effects at all, they did recognize that the drug does not defy the FDA warning mandated in May 2007. The warning is meant to inform patients that GBCAs, which are used in MRIs for better imaging results, can also cause Nephrogenic Systemic Fibrosis, which can lead to serious impairment and even death.

If you or someone you love has been diagnosed with Nephrogenic Systemic Fibrosis, or NSF, and a gadolinium-based contrast agent used in an MRI scan may be to blame, you may be entitled to compensation for your injuries and suffering. Know your rights and a options, and be sure you are in contact with an experience legal team. If you need advice, contact the gadolinium attorneys of Williams Kherkher at 800-761-3187 today.

How often does the FDA review gadolinium?

by Administrator 26. May 2010 02:08

The Food and Drug Administration regularly reviews drugs for various risk factors. These risk factors include harm to patients and adverse side effects. 

At this time, the FDA has put a black box warning on gadolinium. The FDA may change its policy toward gadolinium depending on future reviews. These reviews often look at recent studies or other reports that relate to gadolinium.

If you or anyone you know has questions about gadolinium, contact the gadolinium attorneys of Williams Kherkher at 800-761-3187.

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