Trasylol Recall Lawsuit Lawyers

The U.S. Food and Drug Administration (FDA) announced November 5th, 2007 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.

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Trasylol pulled from the worldwide market
FDA says clotting drug poses increased death risk, while company says drug still has benefits.

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• November 5, 2007 |

MONDAY, Nov. 5 (HealthDay News) -- Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons. ...

The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said at an early morning news conference Monday.

However, he added, "the suspension will include a slow phase-out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs." And he added that Bayer could continue to supply the drug if physicians can identify specific patients who would benefit from it.

"Studies have found that Trasylol can increase the risk of kidney damage compared with other drugs," Dr. Gerald Dal Pan, the FDA's director of the Office of Surveillance and Epidemiology, said during the news conference.

In 2006, he added, the FDA limited the use of Trasylol and strengthened its warnings. Subsequently, he said, studies found that Trasylol increased the risk of in-hospital death among patients undergoing cardiac bypass surgery. In addition, Dal Pan said, two studies this year found that the drug increased the long-term mortality of patients who had undergone bypass surgery.

The suspension follows news last month that a major Canadian trial of the drug was terminated because of an increase in deaths for cardiac surgery patients using it.

The trial was designed to show that Trasylol was better than other drugs in controlling bleeding, Dal Pan said. "That study was halted, because Trasylol appeared to increase the risk for death compared with two other drugs," he said.

Based on these findings, the FDA requested last week that Bayer suspend Trasylol pending further review, Dal Pan added.

In a company statement on its Web site Monday, Bayer stressed that the suspension was temporary. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the statement said.

Heart experts said, however, that the drug's suspension came as no surprise.

"This is not really new news. It has been surfacing in the past year and a half," said Dr. W. Douglas Weaver, president-elect of the American College of Cardiology and co-director of the Heart & Vascular Institute at Henry Ford Hospital in Detroit. "Many surgeons have stopped using the drug. This won't have a huge impact, but surgeons want to know [the danger]."

The FDA plans to do a detailed review of the preliminary results from the Canadian trial before deciding whether to allow Trasylol, which it first approved in 1993, back on the U.S. market.

In the Canadian trial, called BART, an elevated 30-day and overall death risk caused the study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

A month before, on Sept. 12, an FDA advisory panel had recommended that Trasylol remain on the market, despite mounting evidence that it might have serious side effects.

In addition, in February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.

"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."

His team's study tracked the long-term survival of almost 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide and found that the five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid.

After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor Trasylol patients for kidney, heart and brain damage -- an action taken after Bayer itself disclosed study data showing that the drug increased the risk of death, kidney damage, congestive heart failure and stroke.