Trasylol

By Jane Mundy

Trasylol is a drug given to patients by injection before undergoing heart surgery to limit bleeding and the need for transfusions. It has also been used in other surgeries, such as hip replacement surgery. The drug, which is derived from the lung tissue of cattle and marketed by Bayer Pharmaceuticals, was first approved by the FDA in 1993. Since then, studies have linked Trasylol (aprotinin injection) to serious complications including kidney failure and heart problems.

In January 2006, a study published in the New England Journal of Medicine revealed that Trasylol is associated with elevated risk of kidney failure and other serious side effects in patients taking the drug. The study, conducted on more than 4,370 patients undergoing heart bypass surgery, shows that Trasylol raises the risk of a heart failure by 55 per cent and doubles the chance of a stroke. "It's a serious situation," said lead researcher Dennis Mangano, from the Ischemia Research and Education Foundation in San Bruno, California. As well, the study concluded that substituting other generic drugs would prevent as many as 11,050 dialysis complications per year. The study further found that substituting one of these drugs would save at least $1 billion in dialysis costs and reduce drug costs by $250 million. It is estimated that 11,000 patients a year may now be on dialysis as a result of Trasylol use.

On September 21, a public meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee was held to consider changes to the drug's label. Just one week later, Bayer informed the FDA of its own study on Trasylol that showed the drug could increase a user's chances of death, serious kidney damage, congestive heart failure and stroke. The study involved 67,000 patients who had undergone coronary artery bypass graft surgery.

One month later, the FDA issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasylol has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

New Labeling
As a result of these two studies, in December 2006, the FDA issued a stronger "black box" warning on Trasylol's labeling, stating that Trasylol should be administered "only in an operative setting where cardiopulmonary bypass can be rapidly initiated." The labeling for Trasylol now includes a new warning about renal dysfunction, a revised warning about anaphylactic reactions, and a new Contraindication.

The labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion while undergoing coronary bypass graft surgery or for those who are put on a heart/lung machine during surgery.

As well, the labeling rules out administering it to patients with a known or suspected previous Trasylol exposure during the past 12 months.

One Personal Account
When Tom Dubbin (not his real name pending a lawsuit) recently read an article about Trasylsol in the local newspaper it brought back unpleasant memories. "My dad had heart surgery and seemed to be recovering quite well," said Dubbin. "But complications set in a few hours later and they overwhelmed him." His father's kidneys had shut down; he went into renal failure and died a few days later. As his primary caregiver, Dubbin was given a list of medications administered to his father while in hospital, including Trasylol. "Even though Dad died several years ago, as soon as I read about Trasylol, I knew he had been given this drug. And the symptoms were the same," said Dubbin.

"Obviously I can't get my father back, but if we can raise awareness so that other people pay attention and get physicians to know the side effects, maybe we can prevent further tragedies from drugs such as Trasylol."

It is estimated that Trasylol may have been given to as many as 1 million patients since its approval.

Trasylol Side Effects:
  • Difficulty breathing or shortness of breath
  • Increased heart rate
  • Nausea and vomiting
  • Skin irritation and inflammation
  • Sudden chest, leg, head, or groin pain
  • Swelling of the face, lips, tongue, or neck

    If you or a loved one has undergone surgery and as a result developed kidney or renal failure, you may be entitled to compensation by filing a Trasylol lawsuit.

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