Gadolinium Side Effects
Gadolinium contrast agents are injected into the body, to enhance the clarity of MRI scans. However, the use of this contract agent has been linked to many serious health disorders. Nephrogenic systemic fibrosis is the most serious health disorder linked to Gadolinium. In this disorder, excessive fibrous tissues begin to grow on eyes, skin, joints and other internal organs.
NSF is the main reason why the FDA has made it a mandate for all manufacturers of gadolinium to place a black box warning on all the labels, as there is still no definite cure available for this disease. The €black box warning€ is the strongest action that the FDA can issue, just prior to a total recall.
Minor Side Effects: Amongst the most common side effects associated with gadolinium are:
Kidney dysfunction
Irritation of blood vessels or veins to which it is administered
Swelling of the face
Pain in hip bones or ribs
Stiffness of joints with inability to straighten or move the limbs
Unexplained muscle weakness
Red or dark patches on the skin
Rashes, itching or hives on skin
Yellow spots on the whites of eyes
Major Side Effects:
Nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy are the most severe and most common disorders associated with gadolinium. In these types of disorders, all the connective tissues of the body are affected, thereby causing hardening of skin which in turn causes joint immobility. In NSF, even the thigh muscles, lower abdomen, diaphragm and lung vessels can be harmed. Skin hardening, together with the adverse impact of the drug on lungs and diaphragm, can cause breathing difficulties, which can in turn even cause death. There can also be difficulty in extending or bending the arms, legs, hands and feet. There have also been cases wherein the patient was rendered immovable and confined to a wheelchair within weeks of the onset. Patients who are already suffering from kidney problems and still have MRI scans done with gadolinium based dyes are at high risk of developing NSF/ NFD. If you experience any of the afore-mentioned symptoms after getting a MRI done, you may be entitled to compensation.
1997- First case of NSF was reported
2000- First publication of NSF was issued.
2006- Danish Medicines Agency reported the correlation between NSF/ NFD and gadolinium.
The understanding of this problem is still in its early phases; hence no definite treatment plans are yet available for NFS/ NFD. However, the research and studies done on this ailment have concluded that by improving the functionality of kidneys, either by transplant or by natural healing process, we can either curb NSF completely or gradually reverse its effects.
Though MRIs are generally considered safe during a pregnancy, the use of Gadolinium dyes could present special dangers since these dyes pass through the placenta and their long term effects are unknown. As a matter of fact, the FDA disapproves of all types of contrast dyes used in MRIs if the patient is pregnant or nursing a baby. If you are pregnant, planning a pregnancy, or nursing a baby, and a medical provider has proposed an MRI for you, you should confirm whether a contrast agent will be used, and you should discuss the risks with your doctor prior to the MRI.In December 2006, FDA started analyzing the reports of people who were administered gadolinium based contrast agents, to determine and identify symptoms of nephrogenic systemic fibrosis (NSF) and its related risk factors. It also asked all five FDA approved GBCAS' manufacturers to add a black box warning to the labels of the medicine describing the risk of NSF.
The list of FDA approved GBCA is:
Magnevist
MultiHance
Omniscan
OptiMark
ProHance
Other than the addition of the boxed warning, FDA also requested the makers of GBCAs to collect data of patients who have suffered from renal insufficiency after the administration of any of the contrast based drug. The purpose of doing this is to get a continual evaluation of new reports of NSF, and understand the magnitude of risk for NSF patients with kidney disease.
For more information visit http://www.unsafedrugs.com/1413/gadolinium-fda-information
NSF is the main reason why the FDA has made it a mandate for all manufacturers of gadolinium to place a black box warning on all the labels, as there is still no definite cure available for this disease. The €black box warning€ is the strongest action that the FDA can issue, just prior to a total recall.
Minor Side Effects: Amongst the most common side effects associated with gadolinium are:
Kidney dysfunction
Irritation of blood vessels or veins to which it is administered
Swelling of the face
Pain in hip bones or ribs
Stiffness of joints with inability to straighten or move the limbs
Unexplained muscle weakness
Red or dark patches on the skin
Rashes, itching or hives on skin
Yellow spots on the whites of eyes
Major Side Effects:
Nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy are the most severe and most common disorders associated with gadolinium. In these types of disorders, all the connective tissues of the body are affected, thereby causing hardening of skin which in turn causes joint immobility. In NSF, even the thigh muscles, lower abdomen, diaphragm and lung vessels can be harmed. Skin hardening, together with the adverse impact of the drug on lungs and diaphragm, can cause breathing difficulties, which can in turn even cause death. There can also be difficulty in extending or bending the arms, legs, hands and feet. There have also been cases wherein the patient was rendered immovable and confined to a wheelchair within weeks of the onset. Patients who are already suffering from kidney problems and still have MRI scans done with gadolinium based dyes are at high risk of developing NSF/ NFD. If you experience any of the afore-mentioned symptoms after getting a MRI done, you may be entitled to compensation.
1997- First case of NSF was reported
2000- First publication of NSF was issued.
2006- Danish Medicines Agency reported the correlation between NSF/ NFD and gadolinium.
The understanding of this problem is still in its early phases; hence no definite treatment plans are yet available for NFS/ NFD. However, the research and studies done on this ailment have concluded that by improving the functionality of kidneys, either by transplant or by natural healing process, we can either curb NSF completely or gradually reverse its effects.
Though MRIs are generally considered safe during a pregnancy, the use of Gadolinium dyes could present special dangers since these dyes pass through the placenta and their long term effects are unknown. As a matter of fact, the FDA disapproves of all types of contrast dyes used in MRIs if the patient is pregnant or nursing a baby. If you are pregnant, planning a pregnancy, or nursing a baby, and a medical provider has proposed an MRI for you, you should confirm whether a contrast agent will be used, and you should discuss the risks with your doctor prior to the MRI.In December 2006, FDA started analyzing the reports of people who were administered gadolinium based contrast agents, to determine and identify symptoms of nephrogenic systemic fibrosis (NSF) and its related risk factors. It also asked all five FDA approved GBCAS' manufacturers to add a black box warning to the labels of the medicine describing the risk of NSF.
The list of FDA approved GBCA is:
Magnevist
MultiHance
Omniscan
OptiMark
ProHance
Other than the addition of the boxed warning, FDA also requested the makers of GBCAs to collect data of patients who have suffered from renal insufficiency after the administration of any of the contrast based drug. The purpose of doing this is to get a continual evaluation of new reports of NSF, and understand the magnitude of risk for NSF patients with kidney disease.
For more information visit http://www.unsafedrugs.com/1413/gadolinium-fda-information
