Many Patients Concerned about Trasylol

Rockville, MDAccording to reports, Trasylol has been linked to an increased risk of death, kidney or renal failure, heart attacks and strokes among patients who have heart surgery. The drug was used to prevent bleeding during heart-bypass surgery so that patients would not require a blood transfusion, but sales have been suspended because of the increased risk of death in Trasylol patients.

In announcing the Trasylol's suspended sales (in November 2007), Dr. John Jenkins, Director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research said, "At this time, FDA cannot identify a specific patient population where we believe the benefit of using Trasylol outweighs the risk." Essentially, the FDA knows of no group of people who would benefit enough from the use of Trasylol that the risk of harm would be acceptable.

The FDA made its decision to pull Trasylol after receiving word about a Canadian study that was halted because the risk of death from Trasylol was too high. However, the FDA has also said that it is waiting for additional information from that study to fully understand its results and limitations as well as estimate how many people may have died as a result of the use of Trasylol. That additional information was expected early this year.

Heart-bypass surgery is a serious surgery. However, with advances in medicines and surgical procedures, the surgery is not a death sentence. In fact, patients who have the surgery can go on to have long lives. That is why those who have lost family members after the surgery are so concerned that Trasylol may have been used in the surgery: because they expected that their loved ones would pull through the surgery and have many happy years ahead of them, especially in situations where the patient was a relatively young person.

Instead, their loved ones died and they were left wondering how that could have happened. It was only recently that they learned that the problem may have been the use of Trasylol to prevent bleeding during the surgery. Other patients lived, but suffered kidney failure and face years of dialysis.

Given that Trasylol was approved in the US in 1993 and was linked to safety concerns for a while now, it is likely that many patients have suffered serious side effects from the drug for a long time but they, or their families, may not realize it. In fact, a study published in The New England Journal of Medicine (January 26, 2006), found the risk of renal failure require dialysis was doubled in patients who were given Trasylol as opposed to those given different drugs.

Imagine being given a drug and then finding out that the risk of serious, adverse events was double in the drug you were given compared to other drugs that worked just as well. Imagine how that would feel if you suffered a serious, adverse reaction or if a family member had died after being given that drug. Imagine knowing that researchers had recommended the drug not be used any more but you or your loved one had still received it.

If you are reading this article, you or a family member may very well have been in that position and if that is true, then you're not alone. Many people are upset that they and their loved ones were given Trasylol despite the high risk of death, kidney failure and heart problems. Some have filed lawsuits against the maker of Trasylol.