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People are put at risk when a pharmaceutical company releases a drug to the public without making sure it is safe. Pharmaceutical companies all too often dash to receive FDA approval without complete or proper testing. As a result of using such inadequately tested drugs, consumers have suffered serious personal injuries, and sometimes even death.

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Gadolinium Syndrome FAQs - Frequently Asked Questions & Answers

What is gadolinium and what is gadolinium used for?

Gadolinium is a paramagnetic metal ion. Gadolinium-based contrast agents are use in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) scans to obtain an improved image of body organs and tissues.

 

Can magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) scans be performed without using gadolinium-based contrast agents?

Yes, magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) can be performed without Gadolinium-based contrast agents.

 

How does one find out which compound was used for MRI or MRA injection?

Often, patients who undergo MRI or MRA scans are unaware of the identity of the compound that is used in the MRI/MRA injection.  The compound used in a MRI or MRA injection can be found from the accounting records of the hospital.  If you have been scheduled for an MRI or MRA, you should ask prior to receiving the IV.

 

What problems are commonly associated with exposure to gadolinium?

Gadolinium can cause hardening of skin, including rashes, itching, and hives, as well breathing difficulties, impaired kidney function, renal failure and even death.

 

What diseases have been associated with  gadolinium-based contrast agents?

Nephrogenic Systemic Fibrosis (NSF), or nephrogenic fibrosing dermopathy (NFD), has occurred in people with kidney disease.

 

What the chances of recovery from NSF/NFD?

There are no reliable cures for NSF/NFD, although new treatments are being continuously researched.

 

What are the FDA's responses to injuries related to gadolinium?

The FDA’s black box warning on packaging and related literature is designed to prevent improper and illegal marketing of prescription medications by drug manufacturers. The recommended dosage of contrast agent should be administered as per the product label and to be repeated only when previously administered contrast agent is completely eliminated from the body. 

 

What additional actions are likely to follow?

The FDA may consider other risk management options.  The FDA will continue to evaluate any new reports of NSF associated with gadolinium and may request additional clinical studies and/or labeling alterations

 

DILANTIN AND STEVENS JOHNSON SYNDROME FAQs

What is Stevens Johnson Syndrome (SJS) and what are its symptoms?

Stevens Johnson Syndrome is a skin disease resulting from a side effect of a drug reaction and is also referred to as toxic epidermal necrolysis.  Stevens Johnson Syndrome is also referred to as dermatostomatitis, Stevens Johnson type, ectodermosis erosiva pluriorificialis, erythema multiforme exudativum, erythema polymorphe, Lyell's Syndrome, and febrile mucocutaneous syndrome.

SJS can be painful and even deadly.  Soreness or bleeding in the mucous membranes of the lips, mouth, eyes, nasal passages, and genitals are the symptoms of Stevens Johnson Syndrome.

 

What is toxic epidermal necrolysis (TEN) and what are its symptoms?  

Doctors consider toxic epidermal necrolysis (TEN) as a severe form of Stevens Johnson Syndrome.  Patients suffering from toxic epidermal necrolysis have greater skin loss and a higher death rate.

 

Are there any other causes of SJS and TENS?

In the past, SJS was thought to be related to bacterial infections.  In many cases, medical researchers and doctors were unable to determine the exact cause of the disease.

 

What are treatment options for SJS?

Proper diagnosis is the success key to preliminary stage SJS treatment and drugs that cause SJS should be immediately discontinued.  There currently are no treatments for advanced stage SJS.

 

What are the warning signs for Stevens Johnson Syndrome?

An early diagnosis of Stevens Johnson Syndrome (SJS) is the key to success in combating, the possible long-term effects of SJS.  The victim of SJS may have the signs of rashes, skin peeling, and blisters on the body's mucous membranes.

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