Date approved: 1993
Status: Withdrawn except for very restricted research use
Approved uses: Blood conservation agent for heart surgery patients
Off-Label uses: Used in patients undergoing invasive procedures other than heart surgery
• Renal Toxicity
• Kidney Failure
• Heart Attack
• Anaphylactic Reactions
Related topics: Unsafe Drugs
Trasylol is used in heart surgery to suppress blood loss. A January 2006 study in the New England Journal of Medicine claimed that use of Trasylol during bypass surgery can double a patient’s risk of kidney failure, heart attack, stroke and death. The manufacturer, Bayer, says the 2006 study was poorly conducted. Following that study, the FDA recommended that doctors monitor patients who have been given Trasylol.
In November 2007, pressured by regulators around the world, the drug’s manufacturer, Bayer A.G. announced that it had agreed to withdraw the controversial heart surgery drug after a Canadian study suggested that it increased death rates. The FDA has asked for a phased withdrawal of the drug, because of concerns that alternative medicines could run short.
In May 2008, Trasylol was permanently withdrawn except in very restricted research situations.
Television News Report Reveals Unsettling New Information on Trasylol Recall
On February 17th, 2008, the investigative television program 60 Minutes aired a segment on the prescription drug Aprotinin, marketed by Bayer as Trasylol. In the report, we are given the sordid 14 year history of the drug; from concerns before its Food and Drug Association (FDA) approval, an aggressive marketing campaign during the early years of its introduction to the market, to numerous fatalities resulting from common Trasylol side effects.
As far back as the early 1980’s, the concerns over the potentially fatal side effects of Trasylol have been discussed. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe incidents of kidney damage in animals given Trasylol. When he relayed the results of his research to Bayer, they disregarded the information, overlooking a potentially deadly Trayslol side effect. Soon thereafter, similar side effects showed up in patients given the drug in U.S. hospitals. Most common among the Trayslol side effects was acute renal failure, also known as acute kidney failure, resulting from damage to the kidneys. Cautious of it’s continued use, Dr. Nicholas Kouchoukos, one of America’s top heart surgeons conducted a small study on 20 patients given Trasylol. Of those given the drug, 13 had problems with kidney function after taking the medication. Ignoring these results and several other similar studies, the FDA approved Trasylol for use in 1993.
Through a relentless marketing campaign and intense pressure on the FDA, Bayer had all but cornered the market on Trasylol’s use in all open heart surgeries, and was the favored drug to control bleeding in other major surgeries. Sales of the drug hit $300 million in 2005, with projected sales of $750 million for 2006. Dr. Dennis Mangano, a leader in the medical research field, was finishing a study around this same time, a study that had followed the records of 5,065 patients in 17 countries given Trayslol. Published in the New England Journal of Medicine in January 2006, this was the largest Trasylol study ever conducted and ultimately the most illuminating, suggesting not only an association between patients given Trasylol and acute kidney failure, but also an tendency for increased chance of death in the hospital.
When Dr. Mangano presented his results to an FDA advisory committee, the reaction was less proactive than he had imagined. Since Dr. Mangano’s results were based on the hospital records of patients rather than a more traditional study involving a placebo, the committee was hesitant to comply with his request to remove the drug from the market. Unbeknownst to the committee, Bayer possessed the results from a study conducted by hired Harvard professor Dr. Alexander Walker, which looked at the records of nearly 70,000 patients in the same way that Dr. Mangano had conducted his research. Even more amazing were the startlingly similar results that Dr. Walker’s study found: patients given Trasylol had an increased risk of acute kidney failure and death. Bayer’s failure to inform the panel of their confirming results led Dr. Walker to contact the FDA, insisting that Bayer had deliberately withheld potentially damning information to continue lucrative sales of Trayslol. However, the FDA’s only response to the confirmation of the fatal side effects was the issue of another warning to doctors; it would be a full year before the committee would reconvene to reevaluate to efficacy of the drug.
Meanwhile, a clinical study run in Canada in 2007 was halted when participants in the study group began dying. The German government immediately pulled and banned Trayslol; through a combined effort between the Canadian government and the FDA, Bayer was persuaded to put a temporary hold on the continued marketing of the fatal drug.
It is believed that approximately 4.5 million people have been given Trayslol worldwide; a third of those patients, about 1.5 million people, were given the drug in the United States in the 14 years the drug was available. By Dr. Mangano’s estimates, if, in the brief time frame between his study and the most recent temporary moratorium on the drug, the drug had been taken off the market, it could have saved about 22,000 lives – approximately 1,000 people every month.
If you or anyone you know has been administered Trasylol, during a hospital stay or for any medical procedure, it could be in your best interest to locate an experienced Trasylol law firm so that you can be gain the benefit of consultation with an expert Trasylol attorney. If you wish to be contacted by such a qualified Trasylol lawyer, simply fill out the form on this page to receive the legal advice you need.
Trasylol Manufacturer Removes Trasylol from Shelves after Increased Risk of Death Found
Under pressure from medical regulation agencies around the globe, the manufacturer of Trasylol (generic Aprotinin) announced on November 5, 2007 that it would remove the controversial heart surgery drug after a study conducted in Canada appeared to show an increased risk of death among patients on whom the drug was used. The drug’s maker, German pharmaceutical firm Bayer AG, has stated that it still believes the drug to be beneficial. However the study in question, conducted by the Ottawa Health Institute, had to be stopped after it appeared that among the heart and valve surgery patients in the study, though those given Trasylol had increased risk of death, compared to those patients given two older antifibrinolytic drugs used in the study.
Antifibrinolytic drugs such as Trasylol are used during heart surgery because they slow the breakdown of blood clots during, and thus can prevent excessive bleeding. According to the Food and Drug Administration (FDA) there are not many alternatives when it comes to patients at risk for excessive bleeding during heart surgery. Thus, the 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 reducing bleeding during surgery. Therefore, at this point there will be no complete Trasylol recall. However, these recent negative findings concerning Trasylol are only the next in a long line of safety concerns and warnings that have been documented by the FDA.
In September 2006, Bayer A.G. was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study that concluded Trasylol carried potentially greater risks than other similar antifibrinolytic drugs. The FDA was alerted to the study by one of the researchers involved. Although the FDA issued a statement of concern they did not change their recommendation that the drug may benefit certain subpopulations of patients. In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks” and carefully monitor patients. Due to the necessity for such drugs in hear surgery, the FDA did not recommend any withdrawal or Trasylol recall, but did issue a new Trasylol warning label to strengthen safety warnings concerning Trasylol.
This trend of potentially dangerous findings concerning Trasylol illustrates sometimes that once a drug is approved by the FDA, halting its sale is exceedingly difficult. Experts on FDA advisory panels are often hesitant to take widely used medicines out of doctors� hands, even when their safety is uncertain. For this reason it is important for anyone who may have had Trasylol used during a surgical procedure to consult with their doctor about the potential risks involved. The need for serious consultation concerning the safety of Trasylol is perhaps even more important for those who may potentially require Trasylol in a future surgical procedure.
For anyone who believes that, in addition to a medical consultation, they might require any kind of legal advice, contacting an experienced Trasylol law firm may be the best course of action. A Trasylol lawyer experienced in the intricacies of the complex situation involved in this case would be able to offer guidance and information to anyone who may have been affected, or who may have had a loved one affected. Getting in touch with an expert Trasylol attorney can be as easy as filling out the Trasylol lawyer case evaluation form at the top or bottom of this page. Get advice you need on any potential Trasylol lawsuit today!