German pharmaceutical manufacturer, Bayer AG, agreed to withdraw the heart surgery drug Trasylol after the Canadian BART study suggested increased death rates. The Canadian study was cut short when a statistically sigfnificant death rate was found in the data. From this data, the FDA does not know of a specific patient population where the benefits of using Trasylol could outweigh the risks. Only because of concerns of shortages of other drugs, the agency seeks a phased withdrawal of Trasylol. Trasylol (Aprotinin) is used for heart surgery to reduce the risks of excessive bleeding.Bayer is still trying to bring the drug back to the market, claiming it still thinks Trasylol is beneficial when used as directed. The drug might still be used, but only on a case by case basis, where doctors enroll their patient into a Trasylol study, where death rates and kidney failures can be carefully tracked.
The problem is widespread, as nearly 200,000 patients were administered Trasylol last year alone (over half of them in the USA). The drug has been on the market for 14 years.
This is not the first time that a study has shown problems with Trasylol. Other studies have show dangers, including a 2006 study published in The New England Journal of Medicine (NEJM) that demonstrated the drug increased the risks of kidney failure, heart attack and stroke. That research concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.
Bayer has not been forthcoming with data it has developed on this subject. Last year, after narrowly winning FDA panel conclusion to leave the drug on the market, Bayer disclosed that it had sponsored another study of Trasylol suggesting that the drug increased the risks of death and stroke. The company waited until after the Panel had ruled in its favor before it disclosed the results of its study to the agency. Even Bayer scientists, who defended Trasylol at the panel’s hearing, did not mention their own study or its worrisome findings.
If you can believe this, Bayer said that the findings had been withheld as a result of "regrettable human error."
This drug is not the first that Bayer has produced with safety concerns. Baycol, a cholesterol drug made by Bayer, was also pulled from the market after it was shown to cause Rhabdomyolysis. Trasylol is just another example that once a drug is approved, stopping hidden dangers becomes difficult. The past two years show that the FDA can easily be fooled by drug manufacturers into approving drugs that should not be taken to market. Then, once millions of doses are given, statstically significant dangerts emerge, but by then it is too late.
