The German pharmaceutical company, Bayer AG, announced that it will withdraw Trasylol, its controversial drug used for heart surgery, from the market. The withdrawal was due in part to a study performed in Canada which suggested that Trasylol increased rates of death.
The New England Journal of Medicine published the results of a study it conducted finding that Trasylol increased the risks of stroke, heart attack, kidney failure, and death. The research concluded that stopping the use of Trasylol would result in the prevention of 10,000 to 11,000 cases of kidney failure per year along with the savings of over $1 billion dollars per year in the cost of dialysis.
Bayer AG received pressure from the Food and Drug Administration to pull Trasylol from the market. According to Dr. John K. Jenkins, one of the F.D.A’s leading officials, the F.D.A. was not able to identify a specific population of patients where Traysol’s use would result in benefits outweighing its risks.
Trasylol works by blocking the enzymes which dissolve blood clots. The F.D.A. may have approved the drug based on the assumption that any drug that reduces excessive bleeding during the course of heart surgery would be beneficial to patients. The F.D.A. similarly, in the interests of speed, often approves drugs that have not been shown to extend life but have proved effective in lowering cholesterol, shrinking tumors, moderating blood sugar or causing other effects. Once approved, halting sales is exceedingly difficult.
Earlier this year, the U.S. Food and Drug Administration issued a safety alert over the drug Avandia. The F.D.A. noted that safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.
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