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.
---------END OF TRASYLOL NEWS UPATE FOR MAY 15, 2008------
NEWS: February 19, 2008.
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.
---------------END OF TRASYLOL NEWS UPDATE-------------
NEWS UPDATE: November 6, 2007.
FDA ALERT FOR TRASYLOL:
FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp.
has agreed to a marketing suspension of Trasylol (aprotinin injection), 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.
FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks.
However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
See the report on the FDA site:http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol
-------END OF ALERT-------
Hundreds and thousands of men and women worldwide suffer from advanced coronary heart disease, a complicated and life-threatening ailment that occurs when plaque deposits significantly inhibit blood flow to the heart muscles. In many of those cases, a surgical procedure known as a coronary artery bypass graft (CABG) is required to remove the plaque buildup, and facilitate a quick and complete recovery by the patient.
The first coronary artery bypass graft was performed in 1967 at the Cleveland Clinic by Argentinean cardiologist Dr. Rene Favaloro on a patient suffering from coronary artery disease. Before this revolutionary procedure, patients who suffered from potentially fatal cardiac conditions had few options and were forced to live in constant fear. The techniques first developed at the Cleveland Clinic went on to set the standard for more advanced procedures in the years to come, and medical experts speculate that there are 500,000 people in the United States who are alive today because of CAGBs.
During the CABG procedure, physicians have used a drug known as Trasylol to limit the amount of blood loss by the patient during the surgery. Approved in 1993, Trasylol is an Aprotinin injection that was originally considered to be a safe and essential component of in invasive procedures such as CABG, bypass surgery and cardiac surgery. However, a recent health advisory issued by the Food and Drug Administration (FDA) suggests that this controversial medication is neither safe nor essential.
Trasylol has recently been linked to serious side effects like renal failure, heart attacks, strokes, and encephalopathy (damage to brain tissue).
A January 2006 article in the New England Journal of Medicine reported that Trasylol increases the risk of heart attack 48 percent, heart failure 109 percent and stroke 181 percent, according to a study among nearly 4,400 patients. These alarming statistics have led the FDA to an issue an advisory regarding a safety evaluation that is currently being conducted to assess the drug's risks. Additionally, the FDA has advised doctors to carefully weigh the risks and benefits of Trasylol before administering the drug to patients.
The recent firestorm of controversy surrounding Trasylol has extended into the world of litigation. Over the last 13 years, millions of people have been given Trasylol during surgical procedures, and many have encountered post-operative complications that can be attributed to the drug.
Trasylol is a potentially lethal drug, and those to whom it has been administered run a serious risk of contracting a life-threatening ailment. Discussing your situation with an experienced and compassionate Trasylol attorney can help you fight for the compensation that you deserve against those who failed to inform you of the very real risks associated with Trasylol use. Don't let varying statutes of limitations expire before you get the answers that you are entitled to - call a Trasylol lawyer today.
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