ABOUT GADOLINIUM
- Gadolinium is in contrast dyes used to enhance MRI & MRA images
- Gadolinium is FDA-approved for use with MRIs, but not with MRAs
- Exposure to gadolinium can trigger nephrogenic systemic fibrosis in kidney-impaired patients
- Gadolinium is produced by drug companies worth billions of dollars
- The Law Firm of Howard L. Nations handles gadolinium cases & provides free case reviews
See Video: How Gadolinium Can Cause NSF
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WHAT IS GADOLINIUM?
Gadolinium is a paramagnetic metal ion. It is the active ingredient in several different brands of contrast dye used to enhance MRI and MRA images. The dye is injected into the bloodstream by injection or IV before or during the MRI procedure. The dye runs through the system creating contrast so that the MRI image is easier to read.
Dyes that contain gadolinium are referred to as gadolinium-based contrast agents (GBCAs).
Five gadolinium-based contrast agents (GBCAs) have been approved for use in the United States:
| Brand name | Generic name | Approval date |
|---|---|---|
| Magnevist | (gadopentetate dimeglumine) | June 2, 1988 |
| ProHance | (gadoteridol) | November 16, 1992 |
| Omniscan | (gadodiamide) | January 8, 1993 |
| OptiMARK | (gadoversetamide) | December 8, 1999 |
| MultiHance | (gadobenate dimeglumine) | November 23, 2004 |
FDA-APPROVED USES
The U.S. Food & Drug Administration (FDA) has approved GBCAs for use with magnetic resonance imaging (MRI) to provide an improved image of body organs and tissues.
GBCAs are also used with magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels. MRAs often use a higher dosage of contrast dye (up to 3 times as much) as MRIs. Although common, this use is not approved by the FDA. The FDA has not approved any GBCAs for use with MRA procedures.
This is called "off-label use." Healthcare providers may engage in off-label use, but the drug companies are strictly prohibited from promoting or marketing their products for such uses. Regardless, pharmaceutical companies are often caught promoting the off-label use of their drugs. This can lead to serious sanctions and other regulatory actions by the FDA, not to mention serious injuries to the patients who receive these drugs.
Study results show that use of gadolinium dyes by patients with impaired kidney functioning can trigger development of nephrogenic systemic fibrosis (NSF), previously known as nephrogenic fibrosing dermopathy (NFD), a rare and potentially fatal disease. Since patients getting MRAs are often exposed to higher doses of GBCAs, their risks could be greater than those who undergo MRI procedures.
If you or someone you know has developed NSF or NFD symptoms following an MRI or MRA exam, you may be entitled to compensation. Contact our firm for a free case evaluation by one of our pharmaceutical attorneys.
THE DRUG COMPANIES
Gadolinium-based contrast agents (GBCAs) are produced by 4 different pharmaceutical companies in the United States.
1. Bracco
History: Founded in 1927 by Milan Elio Bracco in Italy. Began international expansion in 1987. Entered the U.S. market in 1994 with the creation of Bracco Diagnostics, Inc. and Bracco Research USA.
| Headquarters: | Princeton, New Jersey (Bracco Diagnostics, Inc.) |
| Italy (Bracco) |
Locations: Present in over 115 countries with major entities in Italy, Switzerland, Germany, England, Netherlands, Austria, United States, Canada, China, Singapore, and Japan.
Employees: ~ 2,100 employees worldwide
Net Sales: 769 million Euros in 2005 (more than $1 billion U.S. dollars)
GBCA Products: MultiHance and ProHance
Bracco Diagnostics Inc. is responsible for developing new clinical agents, filing them with the FDA, and selling all Bracco products within the United States and Canada.
2. GE Healthcare
Headquarters: Chalfont St. Giles, United Kingdom
Employees: More than 46,000 people worldwide
Locations: In more than 100 countries
Net worth: $17 billion dollars
| Revenues: | $16.6 billion dollars in 2006 |
| $15.2 billion dollars in 2005 | |
| $6 billion dollars in 2000 |
GBCA Product: Omniscan
GE Healthcare is a unit of General Electric Company.
3. Bayer Healthcare
Headquarters: Leverkusen, Germany
Employees: More than 50,000 people worldwide
Sales: 11,724 million Euros in 2006 = (~$16 billion U.S. dollars)
GBCA Product: Magnevist
Magnevist was Bayer Healthcare's 9th best-selling product in 2006 with sales totaling 323 million Euros (over $440 million U.S. dollars).
4. Mallinckrodt, Inc.
History: Founded by brothers Edward, Otto, and Gustav Mallinckrodt in 1867. Bought by Tyco International and became a business unit of Tyco Healthcare in 2000. On June 29, 2007, Tyco Healthcare split into 3 separate publicly-traded companies, with Mallinckrodt operating within Covidien, a stand-alone healthcare company. Covidien began trading as a public company on July 2, 2007.
| Headquarters: | Hazelwood, Missouri (Mallinckrodt) |
| Mansfield, Massachusetts (Covidien) |
| Locations: | 14 in the United States, 2 in Canada, 1 in United Kingdom (Mallinckrodt) |
| 65 manufacturing facilities in 16 countries (Covidien) | |
| Covidien sales representatives in more than 50 countries | |
| Covidien products distributed in over 130 countries |
| Employees: | Mallinckrodt employs more than 12,000 people worldwide |
| Covidien employs more than 43,000 people worldwide |
Revenue: $9.6 billion dollars in 2006 (Covidien)
GBCA Product: OptiMARK
Covidien is the ninth largest pharmaceutical company in the U.S., based on the number of prescriptions dispensed.
The Nations Law Firm | A National Pharmaceutical Litigation Firm
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