Clotting drug linked to kidney damage
LOS ANGELES -- 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 by 48 percent, heart failure by 109 percent, and stroke by 181 percent, according to a study among nearly 4,400 patients reported today in The New England Journal of Medicine.
The researchers added that 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 T. 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 Food and Drug Administration in 1993. It is now used in a significant number of the 1 million heart surgeries performed worldwide each year, largely because it is slightly more effective and has been well marketed by its manufacturer,
Surgeons and anesthesiologists had suspected potential problems with the drug for many years, but the number of adverse side effects was lost among the huge number of patients given the drug.
''We didn't have good, hard data to prove it," said Dr. O. Wayne Isom, chair of the Department of Cardiac and Thoracic Surgery at New York Presbyterian Hospital/Weil Cornell Medical College.
The new results are ''pretty much undebatable," said Isom, who was not involved in the study.
A spokesman for the FDA said the agency is reviewing the data.
