Trasylol

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Trasylol NEWS: May 15, 2008.

Bayer AG to remove remaining supplies of its heart-surgery anti-bleeding drug Trasylol from the U.S. market.

The Food and Drug Administration said on Wednesday Bayer had notified the agency that it would begin removing remaining Trasylol stock from the U.S. market. Access will be limited to investigational use for certain patients who have no acceptable alternatives, the FDA said. The FDA "supports Bayer's decision to completely remove Trasylol from regular use in the U.S. market," the agency said. Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee commented by saying, ""Thus, in all likelihood, this is the end of the aprotinin story." Bayer said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs. The drugmaker "will work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol," Bayer spokeswoman Staci Gouveia via email.



60 Minutes does show on Bayer Drug Trasylol.

A renowned medical researcher estimates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago. In a scathing documentary the television show 60 Minutes tells of one researcher's findings on the Bayer drug Trasylol.

Featured in the TV show is San Francisco medical researcher, Dr. Dennis Mangano who studied the drug use in 5,065 patients in 17 countries. His studies indicated that patients that were given Trasylol had a greater risk for renal (kidney) failure and other complications.

"It showed an important association between Trasylol use and kidney failure requiring dialysis, Mangano tells Pelley, "And it showed a trend toward increased death in hospital in these patients."

The story goes on to illustrate that Bayer had known the drug was unsafe and did not halt sales. The story also talks about the current role the FDA has in testing these drugs.

Contact our office today and a professional, trained legal representative will listen to your Trasylol issues. Should we feel that you have a sufficient claim, we will act on your behalf at no cost to you. Let us help you get the justice you deserve.

The Journal of the American Medical Association on February 7, 2007, published the findings of an international study that revealed that patients receiving Trasylol therapy were 50% more likely to cause death within five years after heart surgery. Furthermore, the scientists that conducted the new study were the same ones that revealed last year that Trasylol significantly raised the risk of kidney failure, heart attacks, and strokes.

The study found that if Trasylol were substituted for cheaper generic drug deaths would prevent 10,000 deaths around the world over the next five years.

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If you've undergone or watched someone else undergo major surgery, you realize the seriousness of the situation. One slight error and the consequences could be permanent for the patient. A huge problem for those on the operating table has been the possibility of enormous blood loss; thus, Trasylol was developed and introduced.

Created from a cow lung extract, Trasylol is an amino acid that stops blood from coagulating.

During surgery, many patients are given Trasylol to prevent substantial blood loss. Trasylol slows down fibrinolysis, which can lead to the separation of blood clots. And ideally, Trasylol additionally reduces the need for blood transfusions. However, the drug has recently been linked to such dire side effects as heart attack, stroke, and acute renal failure in patients who had been given Trasylol in good faith by their physicians.

In fact, concerns over Trasylol's possible defectiveness (and rush to the market without being sufficiently studied) have led a number of individuals to file lawsuits on behalf of themselves or others.

In February of 2006, the Food and Drug Administration (FDA) issued a press release warning about Trasylol's unexpected side effects. Though the FDA did not specifically instruct physicians to stop using the medication during surgery, the strong language of the FDA release gave many pause. Was Trasylol worth the potentially devastating side effects? And was Trasylol approved before the drug went through enough clinical trials?

If you or someone you care about was given Trasylol and experienced any of the following side effects, you may be entitled to monetary compensation from Bayer (Trasylol's maker) for your suffering:

  • kidney problems
  • heart attack
  • stroke
  • thrombosis
  • myocardial infarction
  • encephalopathy (Note: Italy withdrew Trasylol from the market over fears of bovine spongiform encephalopathy potential, likely from its cow lung extract connection as noted above)

Additionally, if you received Trasylol and suffered a side effect not mentioned above, we want to hear from you. The more information we can distribute about Trasylol's true nature, the better; after all, as a law firm devoted to protecting the public, we are dedicated to the truth.


Comments on This Topic: There are 2 comments related to:
Defective Drugs: News, Statistics and Legal Guide.
 

Harold J says: 2007-06-13 14:50:36
is this still in the news? I haven\'t seen much about it lately.


Tonya says: 2007-07-26 11:10:20
My daddy was given trasylol after his heart bypass surgery and now has kidney failure requiring dialysis 3 days a week. He NEVER had kidney problems before being given this drug. He was in good health aside from needing bypass surgery. Now, he also has arterial fibrillation and congestive heart failure. He has been in and out of the hospital for months now and I feel Trasylol has robbed him of his quality of life. I feel like Bayer Corp. is killing my father and I believe there are many who don\'t even know their problems are due to Trasylol. I know we didn\'t until someone told us to look it up. This drug is STILL on the market despite the proven harmful effects and FDA warnings and will probably injure many more people if nothing is done about it. Apparently health \"care\" is just an oxymoron and all that matters in this industry is big money. What a crock! Something must be done about this!


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Trasylol In The News

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The medication Trasylol, injected into patients during surgeries to reduce the risk of heavy bleeding, was the subject of a serious Food and Drug Administration (FDA) press release issued in Feburary 2006.

In the release, the FDA warned the public and physicians that patients who had been given Trasylol might be in danger, as the drug had been linked to "higher risks of serious side effects". (FDA, 2006) Those side effects included heart attacks, strokes, and kidney problems in patients (most notably in individuals who underwent artery bypass graft surgery.)

The FDA letter to the public continued by stating that providers of Trasylol would be best advised to "carefully assess the benefits and risks of the drug for their patients". (FDA, 2006)

The FDA's press release added that Trasylol usage should be limited (or, quite possibly, avoided), as patients could develop other complications related to the kidneys, central nervous system, or heart should Trasylol be administered. Specifically, such concerns have included reports of renal failure, heart failure, myocardial infarction, stroke and encephalopathy. Not surprisingly, those dangerous side effects led to permanent health issues and lifestyle changes for the patients who were given Trasylol and their families and friends.

Although the FDA did not take Trasylol off the market in early 2006 when they issued their stern warning, the seriousness of their press release has made many Trasylol users and their doctors question whether the drug should continue to be used.

To be sure, by alerting the public (and, by proxy, the media) to the possibility that Trasylol is defective, the FDA has prevented many future patients from adverse affects. But for those who were prescribed Trasylol before the FDA notified the general public, the notice comes under the category of "too little, too late." Reports have also begun to surface from claimants who feel that the use of Trasylol during their surgeries prompted their developing kidney issues, heart attacks, and stroke.

At our law firm, we are just as concerned as you about Trasylol. If you or a loved one was adversely affected after being given the medication, you may be entitled to monetary compensation by Trasylol's manufacturer, Bayer.

Call our office for a free phone consultation to discuss your Trasylol experiences with a trained Trasylol lawyers committed to consumer advocacy. You're under no obligation to file a claim; however, we encourage you to act in your best interest and find out your rights under the law. Contact us today. 8/14

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