FDA Withdraws Trasylol after Controversy

In November 2007, the Food and Drug Administration (FDA) issued a suspension of Trasylol sales worldwide after receiving reports that the drug may cause potentially fatal side effects.

Trasylol, also known as aprotinin, is an injectable medication that promotes blood clotting, and is commonly used during heart surgery and other surgical procedures. Several studies have suggested the drug is linked to kidney failure, heart attack, stroke and death.

Trasylol Side Effects - Kidney Damage, Heart Failure, Stroke, Death

A number of studies have been conducted on the deadly side effects of Trasylol. One study performed by Duke University discovered that 640 of 10,000 Trasylol patients died within a month of their heart bypass surgery. The number later rose to 1,600 Trasylol patients a year. Duke University researchers concluded that Trasylol's mortality rate is two-and-a-half times greater than that of patients given other types of blood-clotting medications during surgery.

Another study published in the New England Journal of Medicine found that Trasylol doubled the risk of kidney failure, increased the risk of heart attack by 55 percent and raised the risk of stroke by 181 percent.

In addition, the FDA has received more than 22,000 reports of death associated with Trasylol use.

Trasylol is manufactured by Bayer Pharmaceutical Corporation and was one of the company's best-selling drugs. More than one-third of all heart bypass procedures in the United States since 1993 used Trasylol.

Trasylol Deaths Preventable

Bayer Pharmaceuticals and the FDA are under scrutiny in a report conducted by CBS' 60 Minutes news program. The report concluded that more than 22,000 deaths related to Trasylol use could have been prevented had the FDA reacted quicker to health studies. Dr. Dennis Mangano published a study in the New England Journal of Medicine in early 2006 that concluded Trasylol could lead to fatal side effects. In response to this report, Bayer conducted an internal study, which found similar conclusions. Despite these findings, Bayer knowingly concealed these reports from the FDA during their meeting in September 2006. The Chairman of the FDA advisory panel stated that if the results of the internal study had been disclosed, he would have voted to recall Trasylol from the market sooner. The FDA issued a suspension of Trasylol sales in November 2007, more than a year after initial studies concluded the life-threatening side effects of Trasylol.

Speaking With a Trasylol Lawyer

Patients who have suffered serious Trasylol side effects are entitled to receive compensation for their medical expenses, lost wages and emotional pain and suffering. Many victims meet with a personal injury attorney in order to build a strong case against Bayer Pharmaceutical Co, the company that failed to properly warn consumers about the potentially fatal side effects of Trasylol. If the victim has died after using Trasylol, the victim's family members or heirs can file a wrongful death claim to offset funeral and medical expenses, as well as their emotional distress and loss of companionship. To learn more about filing a Trasylol lawsuit, contact AWKO today at (888) 255-2956.