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.
In fact, Jenkins said at a second news conference Monday, patients in the Canadian study receiving Trasylol had a 50 percent increased risk of dying compared with patients receiving the other drugs.
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.
There's more on cardiac surgery at the U.S. National Library of Medicine.
SOURCES: Nov. 5, 2007, teleconference with John K. Jenkins, M.D., director, Office of New Drugs and Gerald Dal Pan, M.D., director, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration; W. Douglas Weaver, M.D., president-elect, American College of Cardiology, and division head, cardiovascular medicine, Henry Ford Hospital, and co-director, Heart & Vascular Institute, Henry Ford Hospital, Detroit; Nov. 5, 2007, press release, Bayer AG