What is Trasylol?
Trasylol, manufactured by Bayer, has been used for more than 20 years to help reduce bleeding during surgery. It was most often administered by injection during procedures including heart and liver surgery. Its main purpose is to slow the breakdown of blood clots, and was intended to decrease the need for blood transfusions during surgery and reduce the risk for organ damage due to low blood pressure. Now, consumers should be aware of a Trasylol recall issued by the U.S. Food & Drug Administration (FDA).
What are the risks associated with Trasylol?
In 2006 the drug’s high risks began to come to light. It was then that the Food & Drug Administration learned that the drug’s manufacturer, Bayer, had withheld critical information that showed dangerous risks from Trasylol.
Two studies were published in the New England Journal of Medicine in January 2006 that showed the drug raises the risk of kidney damage and death, as well as increased risk of stroke and heart attack. As a result of this report, the FDA issued a public health advisor in February 2006 about the risks revealed in the studies. Physicians were warned to limit use of the drug.
Then, in September 2006, the FDA put together a special investigation of the drug, to look at the studies in more detail, along with the results of a Bayer worldwide safety review, and any reports of adverse effects collected through the FDA’s own MedWatch program.
But, a WEEK AFTER the special review, on September 29, 2006, Bayer admitted it had done another safety study, which showed even more serious side effects, including death and congestive heart failure, but had not provided the results of that study during the FDA’s initial special investigation.
Bayer said its decision not to make the results of that study known during the FDA investigation was a “serious error of judgment.”
In October 2006 the FDA recommended that doctors severely limit the use of Trasylol, and issued stronger warnings about the drug’s side effects.
The following year, in November 2007, the FDA announced that Bayer had agreed to a marketing suspension of Trasylol.
In May 2008, a new study conducted in Canada, called the BART study, revealed conclusively that one out of every 50 Trasylol recipients dies. The BART study randomly administered one of three similar drugs to patients: Trasylol, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). Experts found that Trayslol’s safety risks were so high, they ended the study early.
Dr. Paul C. Herbert, a critical care physician at Ottawa Hospital and one of the lead investigators, told BusinessWeek magazine that Trasylol represented a 53 percent increase in risk in dying compared to the other drugs.
On May 14, 2008, the FDA announced that Bayer had issued a Trasylol recall affecting all remaining stocks of Trasylol in U.S. distribution. Any further use of the drug is restricted to investigational use.