Trasylol
TRASYLOL ATTORNEYS FOR YOU.
Trasylol (aprotinin injection) was approved by the Food & Drug Administration in 1993 and was used to stop bleeding during heart bypass surgery. However, a study published by the New England Journal of Medicine in January 2006 opined that Trasylol (generic name aprotinin) increased the risk of kidney failure
following heart surgery by more than 2 ½ times (259%). You can read that article HERE.
On May 14, 2008, more than two years after the New England Journal of Medicine published The Risk Associated with Aprotinin in Cardiac Surgery (link above), the Food and Drug Administration (FDA) announced that manufacturer Bayer AG agreed to remove Trasylol from the market.
CBS News documented the horrifying effects of Trasylol in a 60 Minutes broadcast. You can obtain more information by reading the 60 Minutes new article HERE.
Trasylol can cause renal (kidney) failure, often leading to the patient’s death. Trasylol was also proven to increase risk of heart attack, stroke or encephalopathy (degenerative brain diseases). Some symptoms include:
- Difficulty breathing or shortness of breath
- Fast heart beat
- Nausea and vomiting
- Skin rash, irritation or inflammation
- Sudden or severe pain in the chest, legs, head or groin
- Swelling of the face, lips, tongue or neck
Drug History and Serious Adverse Reactions
Originally approved by the FDA in December 1993, Trasylol® is indicated to reduce blood loss and the need for blood transfusion in patients undergoing heart surgery. It is most commonly used in valve replacement/repair and heart bypass surgeries.
On September 21, 2006, the FDA held a public advisory committee meeting to discuss the safety profile for Trasylol® and review two published observational studies. Shortly thereafter, Bayer announced to the FDA that it had carried out a third safety study that the FDA did not know about. Bayer suggested that this new observational study indicated that the use of Trasylol® may increase the risk of death, serious kidney failure, congestive heart failure and strokes.
On November 5, 2007, Trasylol® was voluntarily pulled from the market at the FDA’s request due to findings from a recently conducted Canadian clinical trial known as the BART trial. This study was halted because the death rates in the Trasylol® arm of the study appeared to be higher than the study’s comparison drug.
In addition to this FDA warning, a CBS 60 Minutes story in February 2008 reported on the dangers of Trasylol®. The story quotes one researcher who suggested that as many as 22,000 lives could have been saved had the drug been withdrawn from the market sooner.
On November 19, 2007, the FDA suggested that Trasylol® may have killed more than 200 people. On November 26, 2007, Trasylol® sales were suspended in the United States, which we believe suggests that Trasylol® was associated with sudden death. This higher death rate might be due, in part, to the increased danger Trasylol® may pose to the body’s kidney and cardiovascular systems. Trasylol® will not be available until Bayer and the FDA have had an opportunity to fully evaluate the study’s results.
Trasylol® is also a costly drug to administer, often costing more than $1,300 per dose. Amicar® and Cyklokapron® are drugs indicated for the same purposes and have been deemed safe and effective. Amicar® costs $7 a dose and Cyklokapron® costs $44 per dose.
Damages
If you or a loved one has been injured, recovery is possible for medical bills, pain and suffering, lost income (past and future), and more. Please call today to speak to Tim Edwards or Ed Wallis at 901.527.2125 for more information.
No Recovery, No Fee
Generally speaking, we take cases on a contingent basis. That means that there is generally no cost to you unless we are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you generally do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against Advanced Bionics. If there is a recovery, we are reimbursed our fronting of litigation costs out of any damages you are awarded. So, in a sense, you do not need cash up front to hire us as your lawyer to pursue a claim for personal injuries, emotional injuries, lost business or property damage.
About us
Mr. Edwards and Mr. Wallis are currently representing injured children and adults on an international level for a failed medical device. Both have represented clients, filed lawsuits and appeared in courts around the country to protect the rights of the injured including for the Advanced Bionics HiRes90k cochlear implant, the transvaginal mesh device, the Heartmate II, Composix® Kugel® Mesh Hernia Repair Patch, NexStent®, Medtronic Sprint Fidelis® Defibrillator Leads, and the Zimmer Durom® Cup Hip Replacement. Both also represent patients who have received a variety of defective or suspect medications, including Trasylol, Digitek, Byetta, Reglan and Yaz.
You can read more about Mr. Edwards and Mr. Wallis in the ABOUT US section of this website, and you should feel free to please contact us today for a free case evaluation.
Contacting us
Tim Edwards
Ed Wallis
Glassman Edwards Wade & Wyatt
26 N. 2nd Street
Memphis, TN 38103
(901) 527-2125
(901) 275-0600 (after hours / weekends)
EMAIL BY CLICKING HERE
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