Study Shows Link Between Use of Blood Substitutes, Heart Attack Risk
Posted on: Monday, 28 April 2008, 18:00 CDT
CHICAGO -- In another potential blow to the development of blood substitutes, new research warns against the increased risk of heart attack and death when such products are studied in patients undergoing elective surgery, according to a new study and related editorial published in the online edition of the Journal of the American Medical Association.
The study, published Monday, comes a day before a two-day workshop at the Food and Drug Administration designed to evaluate various issues surrounding blood substitutes.
One such product under FDA review is a blood substitute made by Evanston, Ill.-based Northfield Laboratories Inc., which will submit its blood substitute to the agency later this year for possible approval.
The study, which included a pooled analysis of more than a dozen studies that included some research on Northfield's blood substitute Poolyheme, found a 30 percent increased risk of death for elective surgery patients treated with blood substitutes and a nearly threefold increase in heart attacks.
"Randomized controlled trials completed as early as 1996 have raised questions about the safety of these products and have failed to demonstrate clinical benefit," the authors wrote in the study posted online Monday.
For decades, researchers have attempted to develop a blood substitute hoping it would have great life-saving potential because it has a long shelf-life and does not require refrigeration. Some researchers also believe it could reduce the risk of infection of that of donated blood.
But several companies have failed to win U.S. approval included Deerfield-based medical product giant Baxter International Inc., which stopped research on a blood substitute a decade ago due to an increased risk of heart attack and death. The data evaluated in the JAMA study also included research from Baxter's clinical trials.
Northfield discounted the research, saying such pooled research called "meta-analyses" are "not designed to provide answers about specific products or to examine fully the risk/benefit ratio of any particular product," said Northfield chairman and chief executive officer Dr. Steven Gould. "Rather, that is the role of clinical trials that are focused on a particular product and are conducted to assess the safety and efficacy of the product in relation to a proposed indication."
Source: Chicago Tribune
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