Source | FDA

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.

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.

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.

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. 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.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study’s termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Do I have an Trasylol Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Trasylol lawsuits. We are handling individual litigation nationwide and currently accepting new Trasylol cases in all 50 states.

If you or a loved one have recently undergone heart surgery and subsequently suffered from a heart attack, stroke or developed kidney or renal failure, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Learn More: Trasylol Recall

Source | FDA

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.

Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.

This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees, which represent one part of FDA’s oversight and review of drugs throughout their life cycles.

FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully.

In the meantime, FDA recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.

In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Trasylol is marketed by Bayer Pharmaceuticals Corp., Leverkusen, Germany.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews. Full text of the Early Communication about an Ongoing Safety Review can be found at http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.

Do I have an Trasylol Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Trasylol lawsuits. We are handling individual litigation nationwide and currently accepting new Trasylol cases in all 50 states.

If you or a loved one have recently undergone heart surgery and subsequently suffered from a heart attack, stroke or developed kidney or renal failure, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Learn More: Trasylol Recall

Source | MedPage Today

Trasylol (aprotinin), a drug designed to limit operative blood loss, was associated with a 48% increase in risk of dying within five years of coronary artery bypass surgery, researchers here reported.

In a multi-center, observational study of 3,876 bypass patients, the five-year mortality rate was 20.8% of the patients given Trasylol, versus 15.8% for those treated with aminocaproic acid and 14.7% for those who received Cyklokapron (tranexamic acid), said Dennis T. Mangano, Ph.D., M.D., of the Ischemia Research and Education Foundation here.

These results, published in the Feb. 7 issue of the Journal of the American Medical Association, mark the second analysis of data from the same international registry that linked Trasylol with increased mortality. The first analysis reported that Trasylol increased perioperative risk of death, acute renal failure, myocardial infarction, stroke, and encephalopathy.

Dr. Mangano concluded that taken together there was now evidence of both perioperative and long term risk. “Therefore, continued use of aprotinin in this population does not appear prudent, given that safer alternatives-aminiocaproic acid and tranexamic acid-are available,” he added.

The patients were treated at 62 international centers from Nov. 11, 1996 to Dec. 7, 2006. The researchers assessed survival at six weeks after the index hospitalization, six months, and annually for five years following surgery.

Among the findings:

1,072 patients received Trayslol, 834 received aminocaproic acid, and 442 received Cyklokapron.
At five years there were 223 deaths in Trayslol group, 132 in the aminocaproic acid arm and 65 in the Cyklokapron group.
The five-year hazard ratio for death in the Trayslol arm was 1.48 (95% CI, 1.13-1.93, P=0.005).

In general, Farzan Filsoufi, M.D., associate professor and associate chief of cardiac Surgery at Mount Sinai Medical Center in New York, agreed with the conclusions by Dr. Mangano and colleagues, but he cautioned that as with other recent Trasylol studies, this one was limited by its observational design and lack of randomization. Dr. Filsoufi was not involved in the study.

Dr. Filsoufi’s comment echoed that of T. Bruce Ferguson, Jr., M.D., of the Brody School of Medicine at East Carolina University in Greenville, N.C.

The perioperative observational study findings “seemed to conflict with findings from several dozen randomized trials, two meta-analyses, a Cochrane Collaboration summary on aprotinin use, and an evaluation by the Food and Drug Administration,” Dr. Ferguson wrote in an editorial that accompanied Dr. Mangano’s study.

Dr. Ferguson noted that Trasylol use “has never been uniformly standardized, but generally has been reserved for patients in whom the surgical team anticipated a higher risk for intraoperative blood loss.”

The latest analysis from Dr. Mangano and colleagues included 3,876 of the 4,374 patients included in the perioperative analysis. And seven of the original 69 participating international center were dropped from the five-year analysis, a potential limitation that Dr. Mangano said reduced the cohort size by 11%. But, he said, it had little effect on the findings because “the in-hospital mortality by study group was similarly distributed among the 62 centers participating in this study versus the seven centers that did not.”

Dr. Mangano said selection bias — Trasylol was likely to have been given to patients with more complex or advanced disease — was unlikely to affect or explain the excess mortality because since data were corrected by propensity analysis. Moreover the association with Trasylol and lack of association for the other two agents persisted in among patients with risk factors for in-hospital renal, cardiovascular, and cerebrovascular events.

Do I Have a Trasylol Lawsuit?

If you or a loved one have recently undergone heart surgery and subsequently developed kidney or renal failure and are now undergoing dialysis treatments, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Click Here: Trasylol Lawsuit Review

Source | USA TODAY

An expensive drug given to coronary artery bypass surgery patients to prevent excessive bleeding is linked to an increased risk of dying as long as five years after the operation, researchers have reported.

More than 4 million patients worldwide have received aprotinin, sold as Trasylol, since 1985, the scientists write in the Journal of the American Medical Association. The Food and Drug Administration approved Trasylol for use in coronary bypass surgery patients in 1993. Last year, it was used 246,000 times in the U.S., the researchers say.

Trasylol has been under scrutiny for at least a year and has raised anew concerns about monitoring the safety of drugs once they’re on the market. The new study is a followup to one the authors published in January 2006 that linked Trasylol to serious kidney problems, heart attacks and strokes in patients undergoing coronary bypass surgery. Another study, posted online in January 2006 and published in March, also linked Trasylol to kidney trouble.

The studies spurred the FDA to convene an advisory panel, which in September voted unanimously that Trasylol should stay on the market. The next week, the FDA announced it had just learned of another study, by Trasylol maker Bayer, which the company had not mentioned at the advisory panel meeting. That study suggests that Trasylol might increase the risk of serious kidney damage, death, heart failure and strokes, the FDA said in December, when it announced updated labeling for the drug. The label now warns about kidney problems and says that Trasylol should be used only in coronary bypass surgery patients who are at an increased risk for excessive bleeding.

The new, multi-center international study compared the death rates of four groups of patients who had undergone bypass surgery: 1,072 given Trasylol, 834 given aminocaproic acid; 442 given tranexamic acid and 1,374 who didn’t receive any medication to prevent excessive bleeding. Patients who got aprotinin were about 50 percent more likely to die in the five years after surgery than patients who received no drug. Neither of the other drugs was linked to a significantly higher risk of death than no treatment.

Trasylol costs $1,300 per use, compared with $44 for aminocaproic acid and $11 for tranexamic acid, says lead author Dennis Mangano, head of the Ischemia Research and Education Foundation in San Bruno, Calif. Before his first study came out in January 2006, says Mangano, about half of U.S. coronary bypass surgery patients received Trasylol. But, he says, use of the drug dropped 37.5 percent in the first half of 2006.

“I think that clinicians are going to pay attention, and I think the use of the drug will drop again,” he says.

In a statement responding to the new study, Bayer said that doctors tend to give Trasylol to the sickest of patients, which could skew findings about the drug’s safety. Based on its initial review, “Bayer believes that the results of this study should not serve as a basis for affecting the use of aprotinin . . .”

Keyvan Karkouti, lead author of the other paper last year linking Trasylol to kidney problems, called Mangano’s new report “a good paper, and it definitely raises more questions and concerns.”

In Canada, says Karkouti, an anesthesiologist at the University of Toronto, only bypass patients at the highest risk of bleeding — 5 percent of bypass patients at his hospital — receive Trasylol. Trasylol has been shown to be more effective than no treatment in that group, Karkouti says, but trials comparing its generic competitors with a placebo in high-risk patients haven’t been done, because no drug company stands to gain from such a study.

Do I Have a Trasylol Lawsuit?

If you or a loved one have recently undergone heart surgery and subsequently developed kidney or renal failure and are now undergoing dialysis treatments, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Click Here: Trasylol Lawsuit Review

The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

“FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research. “We’re working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.”

FDA advises health care providers to be aware of the following:

• Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
• Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
• FDA is working with the manufacturer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
  Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.
• Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug aids the body’s ability to stop bleeding and is used to lessen the bleeding risk during this surgical procedure. This surgery is done to bypass clogged arteries.
  .
  FDA is evaluating the studies more closely, along with other scientific literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted. One study, published in the New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks, and stroke compared to treatment with other drugs to prevent bleeding or to no treatment; the second study, reported in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared to another treatment to prevent bleeding. A limitation of both studies was that doctors chose which patients were to receive Trasylol or another treatment. It is possible that patients treated with Trasylol may have been sicker than other patients. The studies used complex statistical methods to adjust for possible differences in patient risk factors.

The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of Trasylol, and if additional safety measures need to be taken. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.

>>> Trasylol Lawsuit and Side Effects Information

The FDA has approved revised labeling for Bayer Pharmaceuticals’ Trasylol (aprotinin) injection to strengthen its safety warnings and to limit its usage to specific situations.  Trasylol is indicated for administration to patients before cardiac surgery to reduce bleeding and the need for blood transfusions.  The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery when also undergoing cardiopulmonary bypass.  The new labeling includes warnings of an increased risk for kidney damage and hypersensitivity reactions, as well as methods to manage and reduce these reactions.

Source | Associated Press

WASHINGTON - The government strengthened warnings on a drug commonly used to lessen blood loss during heart bypass surgery, saying yesterday that doctors should reserve Trasylol for higher-risk patients.

The Food and Drug Administration began re-evaluating the safety of Trasylol, also called aprotinin, last January after studies raised the possibility of kidney failure, heart attacks and strokes after its use.

Yesterday, the FDA strengthened the drug’s label to:

• Specify that Trasylol be given only to patients at increased risk of blood loss during the surgery.

• Warn that Trasylol increases the risk of kidney damage.

• Suggest ways to lower patients’ risk for a life-threatening allergic reaction, and treat them if one occurs.

The FDA still is probing the drug’s potential cardiovascular risks, and left open the possibility of further warnings.

Do I Have A Trasylol Lawsuit?

If you or a loved one have recently undergone heart surgery and subsequently developed kidney or renal failure and are now undergoing dialysis treatments, you should contact us immediately by using the form at the bottom of this page, or by dialing Toll Free (866) 588-0600.

You may be entitled to compensation by filing a Trasylol lawsuit and we can help.