Bayer Suspends Sales of Trasylol.

The U.S. Food and Drug Administration (FDA) today announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. This Trasylol recall or marketing suspension follows two scientific studies confirming the serious dangers of the drug. The initial study, which was the largest worldwide Trasylol study ever conducted, was performed by Dr. Dennis Mangano, the same physician who warned the FDA two years ago about the serious side effects of Trasylol.

According to the Wall Street Journal, Bayer said its decision came in the wake of requests or orders from regulators in the U.S., Canada, Germany and other countries. Trasylol, which is supposed to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions, is the third drug this year whose sale in the U.S. has been halted under scrutiny from the Food and Drug Administration, a signal of how the agency is weighing safety issues heavily in drug decisions.

Still, the history of Trasylol, which was approved in the U.S. in 1993 and has been tied to high-profile safety concerns at least since early 2006, is likely to draw questions from Congress and plaintiff attorneys. It took the FDA eight months to initiate the widespread recall after the physicians’ warnings. These delays in action have been estimated to cause the death of 1,000 patients each month. Bayer has been accused of withholding negative reports about Trasylol from the FDA in order to maintain profits.

On November 5, 2007 the FDA requested Bayer Pharmaceuticals Corp to suspend the further sale or use of the antibleeding drug called Trasylol, amid growing concerns and strong medical evidence that Trasylol may be linked to a higher risk of kidney and renal failures, heart attacks, stroke and death than other antibleeding drugs used during a cardiac bypass, heart catherization or other cardiac surgery or operations.

Trasylol (aprotinin), Bayer’s injectable drug used to prevent excessive blood loss during heart surgery, has produced distrubing results in a recent New England Journal of Medicine study. The New England Journal of Medicine, January 25, 2006, states that patients who were given Trasylol, compared with controls, had nearly double the risk of death, renal failure, or stroke and a more than 50% increased risk of heart attack. Trasylol also increases the risk of kidney damage and kidney failure. If you or a loved one have experienced complications after cardiopulmonary bypass (CPB) or coronary artery bypass graft surgery (CABG), or any serious surgery, you should contact your medical providers to determine if Trasylol was used during the procedure.

Speak to a Trasylol Lawyer

If you or a loved one has suffered a heart attack, heart damage, stroke or kidney failure after Trasylol was used during heart surgery, contact our law firm at once. It may be too late to recover from the debilitating effects of Trasylol, but an experienced product liability attorney can assist you in a legal action against the makers of Trasylol. You are not alone. Join other heart attack, heart damage, stroke and kidney failure victims in speaking up and fighting for their legal rights. You may be entitled to file a lawsuit for your pain and suffering, mental anguish, medical bills and other legal remedies and damages. Contact our law firm today.

If you have had a MRI and a contrast agent was used to enhance the image, you need to read the following. There are two very different and distinct kinds of dyes used and several brands of each dye. If you were given an Iodine-based dye then the following does not apply to you. However, if you were given a gadolinium-based contrast dye then you need to be aware of a serious skin disease that you have an increased risk to.

Gadolinium contrast agents have been linked to Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD). Symptoms of these skin diseases include skin rashes, joint pain, stiffness, kidney failure, and renal failure. Gadolinium contrast agents are marketed under the names: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide), OptiMARK (gadoversetamide), MultiHance (gadobenate dimeglumine) and Prohance (gadoteridol).

Problems with Gadolinium MRI Dye

The potential problem with gadolinium dye result from recent statistical findings discovered in Denmark. On May 29, 2006, the Danish Medicines Agency reported that it had learned of 25 cases where patients who had been administered a gadolinium-containing contrast agent during the previous three months had contracted Nephrogenic Systemic Fibrosis (NSF), a very serious skin disorder. NSF, sometimes called Nephrogenic Fibrosing Dermopathy (NFD), is an incurable skin condition that affects patients suffering from kidney failure.

Types of Gadolinium Dye

Omniscan
(Gadodiamide)
Manufacturer: GE Healthcare

OptiMARK
(Gadoversetamide Injection)
Manufacturer: Mallinckrodt
Manufacturer: Tyco Healthcare

Magnevist
(Gadopentetate Dimeglumine)
Manufacturer: Bayer HealthCare
Manufacturer: Schering AG
Manufacturer: Berlex

ProHance
(Gadoteridol Injection)
Manufacturer: Bracco Diagnostics

MultiHance
(Gadobenate Dimeglumine)
Manufacturer: Bracco Diagnostics

MRI Dye Side Effects

Symptoms associated with gadolinium dye exposure include:

• Itching or burning skin
• Reddened or dark patches on the skin
• Skin rashes, hives or lesions
• Tightening and swelling of the skin, usually in the extremities
• Hardening or thickening of the skin
• Restrictive movement
• Skin texture changes (leathery, woody, scaly, like an orange peel)
• Yellow spots on the whites of the eyes
• Sharp pains in affected areas
• Joint pain or stiffness
• Deep bone pain in the hips or ribs
• Calcification of muscle, skin, or tendons
• Muscle weakness
• Muscle contractures

Speak to a Lawyer

If you or a loved one had a MRI or MRA, and a gadolinium-based contrast dye, medium or agent was used to enhance the MRI image, then your health may be at risk. If you developed Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), skin problems, skin tightening, severe joint problems, kidney failure, or renal failure, then you may be eligible to collect money damages for your injuries. Please contact our law firm by filling out our legal evaluation form on the far right for a free and confidential case evaluation. Please keep in mind that certain states limit the amount of time you have to file a lawsuit; contact an attorney as soon as possible.

The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.

“FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “This latest action demonstrates FDA’s continuing vigilance about ensuring the safety of drug products once they enter the marketplace.”

Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006 . Information on the risks was updated in December.

Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.

NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.

Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.

There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.