A drug widely used during heart surgery to control bleeding doubles the risk of kidney damage, forcing an estimated 10,000 patients onto dialysis each year, according to a new study from a group that is calling for surgeons to abandon its use.
Known as aprotinin, the drug also increases the risk of heart attack 48 percent, heart failure 109 percent and stroke 181 percent, according to a study among nearly 4,400 patients reported today in the New England Journal of Medicine.
The researchers said the drug is not even needed in most cases because there are two generic drugs that cost a tenth as much and are nearly as good at stopping bleeding without increasing risks.
“I wonder how we can ethically prescribe aprotinin when there are alternatives that are safer,” said Dr. Dennis Mangano of the Ischemia Research and Education Foundation, who led the study.
The drug, which is derived from the lung tissue of cows, was approved by the Food and Drug Administration in 1993. It is used in a significant number of the 1 million heart surgeries performed worldwide each year.
An FDA official said the agency is aware of the study and is reviewing the data.
Bayer, which manufactures the drug and sells it under the brand name Trasylol, said in a statement that it had not yet analyzed the study, but that the results were not consistent with its own experience.