Gadolinium (generically known as Gadoliamide) has been approved by the FDA for use as a MRI Contrast Dye. It is used in MRI’s to better observe lesions with abnormal vascularity in the brain, spine, and associated tissues. It is manufactured by GE Healthcare, Mallinckrodt/Tyco Healthcare, Bayer/Schering AG/Berlax, and Bracco Diagnostics. The Gadolinium Contrast Dye brand names include the following: Omniscan by GE Healthcare, OptiMARK by Mallinckrodt/Tyco Healthcare, Magnevist by Bayer/Scherin AG/Berlax, and ProHance and MultiHance by Bracco Diagnostics. Gadolinium at first gained favor when endorsed for MRI scans in 1998 because the use of iodine-containing contrast agents are still a cause of hospital-acquired acuter renal failure and is associated with increased death and morbidity.
Magnetic Resonance Angiography or MRA is a type of MRI used to provide pictures of the blood vessels inside the body. Often gadolinium based MRI contrast agents are used to enhance these images, although this use of gadolinium has never been approved by the FDA. For the contrast agents to be effective in a MRA, they must be administered at three times the approved dose.
After receiving an MRI or MRA patients should watch for the following symptoms: skin hardening or tightening, darkening patches of skin, burning or itching sensation, stiff joints or difficulty moving, pain in the ribs or hip area, muscle weakness, or kidney or renal failure.
Contact the attorneys of the Singleton Law Firm today if you believe that you were injected with this medication.
The side effects of Gadolinium include the following: swelling, hardening, and tightening of the skin; reddened or darkened patches on the skin; burning or itching of the skin; yellow raised spots on the whites of the eyes; stiffness in the joints, problems moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or rips; muscle weakness; Nephrogenic Systemic Fibrosis (NSF)/Nephrogenic Fibrosing Dermopathy (NFD). These symptoms may appear within two days to 18 months after exposure to the gadolinium, patients with a higher dosage developed NSF.
Nephrogenic Systemic Fibrosis, also known as Nephrogenic Fibrosing Dermopathy, is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Patients developing NSF develop large areas of hardened skin with fibrotic nodules and plaques. Warning signs of NSF include the following: burning, itching, swelling, hardening, and tightening of the skin; red or dark patches on the skin; yellow spots on the whites of the eyes; stiffness in the joints with trouble moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or ribs; and/or muscle weakness. NSF has been shown to affect the internal organs, including the abdominal muscles, diaphragm, and lungs.
It can take days, weeks, and sometimes months to develop the symptoms of NSF/NFD. Rapid and full progression of the disease can be fatal. Symptoms of NSF include tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes trunk; thickening of the skin around the joints, restricting movement; skin that feels woody and has a texture similar to that of an orange peel; red or dark patches of skin; burning, itching, and/or sharp pains in affected areas; fluctuating hypertension preceded by the appearance of skin lesions; symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms; muscle weakness; deep bone pain in the hips and ribs; calcification of the soft tissues; or yellow plaques near the eyes.
There is no cure for NSF at this time and successful treatment in rare. The effectiveness of the different treatment options is very inconsistent. In some, the progression of the disease can be halted, and in few symptoms are actually reversed. Potential treatment options include the following: improving renal function (most successful so far), physical therapy, oral steroids, ultraviolent therapy, extracorporeal photopheresis (ECP), topical dovonex, plamsmapheresis, Pentoxifylline (PXF), Plaquenil, or Thalidomide.
Most of these treatment options have serious side effects, especially when use for prolonged amounts of time. Physical therapy is the safest option and is recommended for all NSF patients, but provides limited improvement in most. Each patient responds differently, and it is difficult to predict which treatment will be successful in which patient.
In June of 2006 the FDA issued a warning against gadolinium based contrast dyes. It warned healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. These cases were limited to one contrast dye, but three were more associated with the onset of NSF. At this warning, the FDA cautioned physicians to screen patients for liver troubles before using the gadolinium based dyes.
In December 2006 the FDA claimed to have received reports of 90 patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast dyes. At the time of this alert, 215 patients worldwide were known to have NSF, of those whose medical history were known all had been exposed to gadolinium contrast agents prior diagnosis.
In May of 2007, the FDA requested that the manufacturers of the contrast dyes include a Black Box Warning on product labels highlighting the risk they posed to patients with kidney problems. After the tests, the gadolinium is removed from the body by the kidneys. Gadolinium is a very toxic substance, and when the kidneys are not functioning correctly the drug is allowed to remain in the body.
Contact the Singleton Law Firm immediately if you or a loved one have experienced any side effects from Gaolinium.
Return to the Defective Drugs Listing > |