>>INFORMATION: Trasylol Recall Lawsuits

Trasylol, also known as an aprotinin injection, was widely used for many years during cardiac bypass surgery to control bleeding during surgery. However, safety concerns began to surface in 2006 after a study suggested that those treated with the drug may face an increased risk of death, heart attack, stroke or kidney failure.

In October 2007, a Canadian study known as BART (Blood conservation using Antifibrinolytics in Randomized Trial) was stopped by researchers after preliminary results found that those treated with Trasylol had a high death rate when compared head-to-head against those who were given cheaper alternative medications.

On Wednesday, the New England Journal of Medicine released an analysis of data from the study which involved 2,300 people. Researchers found that six percent of those given a Trasylol injection died within 30 days of heart surgery, which was a 54% greater risk of death when compared to those taking two other anti-bleeding drugs, Amicar and Cyklokapron.

TRASYLOL RECALL LAWSUITS

Bayer currently faces hundreds of potential Trasylol lawsuits which are being pursued on behalf of those injured by the heart surgery injection. In addition to marketing an unreasonably dangerous medication that did not contain adequate warnings, the drug maker has also been accused of actively covering up damaging data about the safety of the drug.

Although most people who were given aprotinin are unaware of the name of the injection they received, the Trasylol lawyers at Saiontz & Kirk, P.A. are reviewing potential cases for anyone who suffered a heart attack, stroke, kidney failure or death within 30 days of heart bypass surgery. To review a potential claim, request a free consultation.

>>INFORMATION: Trasylol Heart Surgery Injection Problems

The current issue of the New England Journal of Medicine contains two studies which provide additional information about the potentially fatal problems associated with the Trasylol injection, which is given to reduce bleeding during open heart surgery. Researchers found that individuals were more likely to die after receiving a Trasylol injection when compared with patients who received a different drug or no treatment at all for bleeding during surgery.

The first study reviewed records for over 10,000 heart surgery patients at Duke University Medical Center, comparing death rates for those who were given the Trasylol heart surgery injection to those who were given older medications or no medication to limit blood loss. The study confirmed the connection between Trasylol use and kidney damage, and found users of the drug were more likely to die than those who were not given Trasylol. Data indicated that 6.4% of patients who received a Trasylol injection died within 30 days and almost 16% died within a year of surgery, which was approximately 2.5 times higher than those who did not receive the antibleeding injection.

The second study, which was funded by the Trasylol manufacturer, Bayer, reviewed data from over 78,000 heart surgery patients, comparing those who were given a Trasylol injection to those who received aminocaproic acid, another medication used to prevent excessive bleeding. The researchers found that the risk of death following heart surgery was 64% higher in patients who were given Trasylol, even after controlling for other possible factors. Additional complications requiring postoperative revascularization and dialysis also occurred more frequently in patients who received Trasylol.

TRASYLOL HEART SURGERY INJECTION LAWYERS

The Trasylol lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits nationwide on behalf of individuals who were diagnosed with kidney failure, a heart attack, stroke or death within two weeks of receiving the injection to control bleeding during heart surgery. While the drug was on the market, thousands of heart patients received the injection every year, and many patients and their families remain unaware that Trasylol could be responsible for serious problems encountered after open heart surgery.

To find out whether you, a friend or family member received a Trasylol heart surgery injection, and to determine whether compensation may be available for serious or fatal problems following bypass surgery, request a free consultation.

>>INFORMATION: Trasylol Injection Lawsuits

Trasylol, also known as an aprotinin injection, was manufactured by Bayer and commonly administered before heart surgery to reduce the risk of bleeding. At one time, the injection was given during as many as one out of every three heart bypass surgeries in the United States, and researches indicate it may have caused as many as 1,000 deaths every month.

During the 60 Minutes story, Dr. Dennis Mangano, a research who published the study regarding the dangers of Trasylol in January 2006, estimates that as many as 22,000 Trasylol deaths could have been avoided if Bayer had acted responsibly and removed the heart bypass surgery injection from the market when his research was first published.

Despite the fact that the dangers of Trasylol side effects were known to Bayer, they did not issue a Trasylol recall until November 2007, when the FDA requested the drug be removed from the market after a different observational study confirmed the link between the heart surgery injection and kidney failure requiring dialysis and an increased risk of death for those patients.

During the 60 Minutes Trasylol report, Dr. Mangano also indicated that Bayer failed to notify the FDA at a September 2006 advisory panel meeting that their own research confirmed the heart surgery injection problems. The chairman of that FDA advisory panel, Dr. William Hiatt, told 60 Minutes that he would have voted for a Traylol recall back in 2006 if Bayer had not withheld the data from their study.

The CBS 60 Minutes heart surgery injection report will be broadcast this Sunday, February 17 at 7:00 p.m ET/PT.

TRASYLOL HEART SURGERY INJECTION LAWSUITS

For nearly two years, the Trasylol lawyers at Saiontz & Kirk, P.A. have been reviewing potential lawsuits on behalf of individuals who suffered kidney failure, heart attacks, strokes or death after receiving an injection during open heart bypass surgery. Unfortunately, many individuals and their family members remain unaware that problems may be related to the heart surgery injection.

To determine if you, a friend or family member may have suffered injuries following heart surgery which are related to the Trasylol injection, request a claim evaluation. Our attorneys can evaluate the circumstances surrounding the surgery and review medical records to help determine if a Trasylol shot was given before surgery. Request a free Trasylol lawsuit consultation.

>>INFORMATION: Trasylol Side Effects

Trasylol, an aprotinin injection, was approved by the FDA in 1993 as a medication to control bleeding during open heart surgery.  The injection has been given to about 4.8 million people who could be prone to blood loss complications during bypass surgery.

Although the medication may slow blood loss during surgery, Trasylol side effects could increase the risk of death and other serious injuries.   A recent Canadian study was suspended after preliminary data indicated that users face a 50% higher risk of death when compared to other drugs used for a similar purpose

The FDA has been closely monitoring the Trasylol risks for nearly two years.  In January 2006, a study published in the New England Journal of Medicine indicated that Trasylol side effects could double the risk of kidney failure and increase the risk of heart attacks, heart failure and strokes.  In December 2006, the FDA added a black box warning to the heart surgery injection, which is the strongest warning the drug regulators can place on a medication.  Last month, the FDA requested that the manufacturer, Bayer AG, recall Trasylol from the market due to the risk of serious injury and death.

According to the New York Post, FDA officials reported that they have received 235 reports of individuals who died after receiving a Trasylol injection to control bleeding during heart bypass surgery.  Most experts agree that this is likely only a small fraction of the true number of Trasylol deaths which have occurred, since most injuries are not reported and many were likely unaware that deaths which occurred before 2006 could have been caused by the Trasylol injection.

TRASYLOL SIDE EFFECT LAWSUITS

The lawyers at Saiontz & Kirk, P.A. have been representing individuals pursuing potential Trasylol lawsuits since February 2006.  Since most people are unaware that they or a loved one received the aprotonin injection, our lawyers are investigating potential claims for any individuals who suffered kidney failure, a heart attack, stroke or death following heart bypass surgery.  Cases are being reviewed to determine if the injury may be the result of Trasylol side effects.

If you, a friend or family member believe an injury or death may have been caused by the heart surgery injection, request a free Trasylol lawsuit evaluation.

>>INFORMATION: FDA Trasylol Notice

Trasylol, known generically as an aprotonin injection, was approved by the FDA in 1993.  It is administered before heart bypass surgery to reduce blood loss and avoid the need for a transfusion. 

In January 2006, a study published in the New England Journal of Medicine found that Trasylol side effects could double the risk of kidney failure and increase the risk of heart attacks, heart failure and strokes.  As a result of these findings, a “black box” warning was  added to the injection in December 2006 and sale have fallen sharply as doctors looked to safer alternatives for their patients.

Last month, Canadian researchers stopped enrolling new patients in a study designed to evaluate Trasylol after preliminary data found that there was a statistically significant increase in the risk of death at 30 days after use of the heart surgery injection.  In addition, while Trasylol was associated with less serious bleeding, more people who received the aprotonin injection died due to hemorrhage than those who received a different drug.

>>PRIOR POST 10/28/2007: Trasylol Death Risk

The temporary suspension of marketing requested today by the FDA was initiated because of the serious nature of the risk suggested by preliminary data from the Canadian study.  The FDA indicates that they have not yet received the complete data from the study, but that they will act quick to thoroughly analyze the benefits compared to the Trasylol death risk.

The Trasylol recall will remove the heart surgery injection from the market in such a way that it does not cause a shortage of supply for other drugs used to control bleeding during heart surgery.  In addition, the FDA may explore possible ways to have limited Trasylol use for situations where doctors identify specific cases where the benefits outweigh the risk of death and serious injury.

TRASYLOL RECALL LAWSUITS

The Trasylol lawyers at Saiontz & Kirk, P.A. represent several clients who have died or suffered serious injuries, such as kidney failure, heart attacks and death after receiving the heart surgery injection.  Many individuals are unaware that they were given a Trasylol injection before bypass surgery.  Therefore, potential cases are investigated to obtain medical records and determine whether injuries may be related to the use of aprotinin to control bleeding.

If you suspect that kidney failure, heart attack, stroke or death suffered by a loved one after cardiac bypass surgery may be related to an injection given before surgery to control bleeding, request a free consultation and claim evaluation.

>>INFORMATION: Trasylol Lawsuits

Trasylol is the brand name for an aprotinin injection, which is manufactured by Bayer Pharmaceuticals Corp.  It is given to prevent excessive bleeding during heart surgery and to avoid the need for a blood transfusion.  It works by blocking enzymes that dissolve blood clots, reducing the risk of serious blood loss.

Although an FDA advisory panel reviewed the safety of Trasylol last month, the agency indicates that they anticipate a re-evaluation after the findings of the study in Canada regarding the Trasylol death risk.

The Canadian trial is known as the “BART study” (Blood conservation using Antifbrinolytics: a Randomized Trial in a cardiac surgery population).  It was designed to establish that Trasylol was better than epsilon-aminocaproic acid and traexamic acid in decreasing blood loss associated with cardiac surgery.

Researchers intended to enroll approximately 3,000 Canadians who were undergoing cardiac surgery, which could place them at a risk for bleeding.  However, the Data Safety Monitoring Board recently recommended that researchers stop patient enrollment in the Trasylol treatment group.  Preliminary data from the study found that:

• There was a statistically significant increase in the risk of death at 30 days after use of the heart surgery injection
• While Trasylol was associated with less serious bleeding, more people who received Trasylol died due to hemorrhage than in those who received a different drug.

Last month, an outside panel of FDA advisors met and recommended that the U.S. regulatory agency not issue a Trasylol recall, depite evidence that it is linked to an increased risk of death and other serious injuries.  However, following the findings of the Canadian researchers, the FDA will now reevaluate the risks and benefits of Trasylol and determine whether label changes or other regulator actions may be necessary.

On Thursday, the FDA issued an early communication warning that healthcare providers who are considering the use of Trasylol should be aware that data suggests the Trasylol death risk is increased when compared to other antifibrinolytic drugs.

TRASYLOL LAWSUITS

The lawyers at Saiontz & Kirk, P.A. have been reviewing potential Trasylol lawsuits since February 2006.  Many individuals are unaware that they received the aprotinin injection before heart bypass surgery, so potential claims are being investigated for any individuals who suffered kidney failure, a heart attack, stroke or death following heart surgery.  If you, a friend or family member suspect you may have a claim, request a free consultation.

>>PRIOR POST (9/11/2006): Heart surgery injection increases risk of
kidney failure and death

Trasylol is a heart surgery injection given to control bleeding and reduce the need for a blood transfusion as a result of bypass surgery.  However, studies released in 2006 suggested that use of the drug doubled the risk of kidney failure, leading to a  “black box” warning which was added in December.  Two more recent studies have suggested that the injection could also increase the risk of death.

Prior to the hearing last week, the FDA provided documentation to the panel which suggested that the use of Trasylol is associated with an increased risk of death, renal failure, heart attack and stroke.  After reviewing new data which they did not have in September 2006, the panel of outside experts recommended that additional studies be conducted to look at the safety concerns and said that the label should be updated to discuss the potential of an increased risk of death.

TRASYLOL LAWSUITS

As a result of the manufacturer’s failure to provide accurate and complete warnings about the problems associated with the heart surgery injection, serious and potentially life threatening injuries have been suffered by individuals after undergoing heart-bypass surgery. 

Trasylol injection lawsuits are being reviewed throughout the United Stated by the lawyers at Saiontz & Kirk, P.A.  If you, a friend or family member suffered kidney failure requiring dialysis, a heart attack, stroke or death after receiving an injection to control bleeding during heart surgery, request a free claim evaluation.

>>INFORMATION: Heart Bypass Surgery Injection Problems

The FDA advisory panel will meet in Washington, D.C. to review the safety of Trasylol and to evaluate new information about the side effects associated with the injection.  An earlier advisory panel which met last year in September 2006, found that data indicated Trasylol carries significant risks, but the drug was allowed to remain on the market with stronger warnings and restrictions on the situations where it can be used. 

Immediately following the 2006 advisory panel meeting, damaging data was released which strongly suggests that the Trasylol injection increases the risk of death, serious kidney damage, congestive heart failure and stroke.  The manufacturer, Bayer AG, failed to provide the FDA with this information from a study involving about 67,000 records.  Although the company claims that their failure to provide the data was only a mistake, it is suspected that employees at the company may have been attempting to conceal or cover up the damaging information.

At the advisory meeting tomorrow, a panel of experts will meet again to evaluate the new data and determine what steps need to be taken to protect consumers.  Many believe that they should recommend a Trasylol recall, since cheaper and safer generic drugs are available which doctors could use for the same purpose.  After reviewing the data, the panel could also recommend stronger warnings or further restrictions on the use of the drug instead of a recall.  Although the FDA is not required to follow the recommendations of their expert panels, they usually do.

Trasylol is given as an injection before cardiac bypass surgery to reduce blood loss and prevent the need for a blood transfusion.  The heart surgery injection was approved by the FDA in 1993, and has been heavily promoted by Bayer.  Originally it was believed that the product could generate sales of over $500 million annually for the company, but Bayer has seen sales fall sharply since they were told to add the stronger warning to the label last year by the FDA.

BYPASS SURGERY INJECTION LAWSUITS

The Trasylol lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits for individuals who have experienced kidney failure, heart attacks, strokes or death after receiving a heart bypass surgery  injection to control bleeding.  Many individuals are unaware of the name of the injection they received, but following a free consultation, potential claims are further investigated to determine whether a Trasylol injection was administered.

To determine if problems suffered following heart surgery may have been caused by an injection before surgery, request a free claim evaluation.

>>PRIOR POST (12/18/2006): Trasylol heart surgery injection warnings

Trasylol is a heart surgery injection which is administered to reduce blood flow and prevent blood loss during surgery.  It has been linked to an increased risk of kidney failure, heart attacks, strokes and death.  A study published in February 2007 in the Journal of the American Medical Association reported that individuals who received the heart surgery injection died at a rate two-thirds higher than those who did not receive the drug before surgery to reduce bleeding.  Researchers found that one out of every five patients who received Trasylol died within five years.

The FDA will convene a second advisory panel hearing next month to review additional information which has been discovered since their last meeting in September 2006.  Bayer has disclosed that two of their senior employees knowingly withheld information from the FDA about problems caused by the heart surgery injection.  The company employed a firm to conduct an investigation which found that the failure to provide the damaging information was due to human error, as opposed to a cover-up.  However, the fact that the investigation was paid for by Bayer calls into question the validity of the findings.

The advisory panel will make a recommendation to the FDA about what steps should be taken to protect the public.  This could include a Trasylol recall if the panel determines that the risk of death and serious injury outweighs the potential benefits provided by the drug.  Although the FDA is not required to follow the recommendations of their advisory committees, they usually do.

TRASYLOL LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are investigating Trasylol lawsuits for individuals who suffered from kidney failure, a heart attack, stroke or death following heart surgery where an injection was given to control bleeding.  Approximately 60,000 people were given the heart surgery injection in 2006, and if information had been provided about the dangers of this medication many serious and potentially fatal injuries could have been prevented.

Bayer aggressively marketed Trasylol to surgeons who could have used a less expensive and safer alternative if they had been provided accurate information about the risks.  It has been estimated that since the drug was approved in 1985, up to 10,000 deaths a year worldwide could have been caused by the heart surgery injection.

If you, a friend or family member received an injection prior to heart surgery and subsequently suffered from kidney failure, a heart attack, stroke or death, request a free consultation.

This month a study published in the Journal of the American Medical Association reports that more than one out of every five patients who received the Trasylol heart surgery injection died within five years.  The fatality rate was two-thirds higher than for surgery patients who were not given drugs to reduce bleeding.

Experts have estimated that replacing the aprotinin injection with cheaper and safer alternatives could prevent as many as 10,000 deaths worldwide each year.  Since 1985, over 4 million patients have been given the Trasylol heart surgery injection.  In recent years it has been used more frequently following heavy marketing directed to surgeons.  Over 600,000 patients received the injection in 2005 alone.

Recently Trasylol side effects have generated great concern within the medical community.  In January 2006 a study was published linking the heart bypass surgery injection to an increased risk of kidney failure, heart attacks and strokes.  As a result, sales dropped nearly 37% in 2006.

Experts have questioned whether the medication should have been approved by the FDA and what steps need to be taken to protect patients.  In September 2006, an FDA advisory panel decided against a Trasylol recall, allowing the aprotinin injection to remain on the market.  In December 2006, the FDA announced that there would be a stronger Trasylol warning attached to the injection and that use should limited to only certain situations.

>>RECENT POST (12/18/2006): Trasylol injection warning update

Trasylol injections cost up to $1,500 for each patient, compared with safer alternatives which cost between $11 and $44.  According to the study published this month, the cheaper alternatives did not carry the increased risk of death over the five years after the surgery.

TRASYLOL APROTININ LAWSUITS

Trasylol lawsuits have been filed on behalf of individuals who suffered injuries as a side effect of the heart bypass surgery injection.  Lawsuits are being reviewed for heart patients who suffered kidney failure, heart attack, stroke or death.

Many of the patients who suffered injuries were not aware that this medication may have caused their problems.  During most surgeries, the patient is not told of the name of the drug they receive and may not realize they were given an aprotinin injection.

The Trasylol lawyers at Saiontz & Kirk are reviewing potential lawsuits nationwide, and can determine if an injection given during heart surgery may have caused a subsequent kidney failure, heart attack, stroke or death.  If you, a friend or family member experienced any of these problems following heart surgery, request a free consultation and claim evaluation to determine if you may have a case.  There are no fees or expenses unless a recovery is secured.  Click here for a free case evaluation.

>>MORE INFORMATION: Trasylol injection lawsuits

The Trasylol (aprotinin) injection may be given before heart surgery to reduce bleeding.  The manufacturer, Bayer Pharmaceuticals Corporation, has previously failed to properly warn users and the medical community of the serious and life threatening side effects associated with their product.  For many users, safer and less expensive alternatives may have been available, which could have reduced the risk of Trasylol kidney damage and other serious injuries.

On December 15, 2006, the FDA announced the new label change which is designed to inform physicians and patients about the Trasylol injection dangers and to make sure the product is only used for specific situations.  The manufacturers have promoted the Trasylol injection heavily to heart surgeons and other medical providers.  However, the FDA has indicated that it should only be marketed for use in patients who are at a high risk for blood loss and blood transfusions.

TRASYLOL INJECTION LAWSUITS

Saiontz & Kirk has been reviewing potential Trasylol injection lawsuits since February 2006.  Despite known risks, the manufacturer has failed to sufficiently warn patients and the medical community.  As a result, thousands of serious injuries have been suffered which might have been preventable.

Trasylol studies have confirmed that the injection increases the risk of kidney failure, heart attacks and strokes when compared with other treatments.  In addition, preliminary results from a new study announced in September 2006 suggest the Trasylol injection also increases the risk of death or congestive heart failure.

Trasylol lawsuits are being pursued for individuals who have received the heart surgery injection and suffered kidney damage, a heart attack, a stroke or death.  To determine if you or a loved one may be entitled to compensation, request a free claim evaluation.