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Trasylol Named in 78 Lawsuits
May 20, 2008
To date, Bayer HealthCare Pharmaceuticals Inc. has been hit with 78 lawsuits over its drug Trasylol, which is given during heart surgery to control bleeding. The Trasylol lawsuits allege that Bayer ignored studies showing that Trasylol is unsafe and failed to warn consumers about the severe side effects associated with the drug. Among Trasylol’s potential side effects are: kidney failure, heart attacks, stroke, and death.
On May 14, 2008, Bayer announced that it was completely removing Trasylol from the market. Although Trasylol sales have been suspended since 2007, doctors were still administering Trasylol to patients from existing supplies. Now, Bayer has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock.
Trasylol was the subject of several FDA safety reviews before it was finally pulled from the market last year. In December 2006, following an advisory panel meeting a few months earlier, the FDA updated the Trasylol label to include a black box warning, which is the agency’s most serious safety warning. The Trasylol black box warning stated that the drug placed patients at a high risk of kidney failure and death. Additionally, the black box warning cautioned that Trasylol should only be used on patients at risk for significant blood loss during bypass surgeries.
In September 2007, another FDA advisory panel agreed with the assessment that Trasylol had a high risk of causing serious side effects. Although this advisory panel recommended that Trasylol undergo further clinical testing, it voted to allow Trasylol to stay on the market. Then in November 2007, the Canadian Data Safety Monitoring Board stopped a Trasylol trial called the BART clinical study because a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance.� Following these revelations, Bayer finally suspended sales of the drug in the U.S., Canada and Germany.
During the 14 years that Trasylol was on the market, more than 4.77 million patients received the drug. In 2006 alone, approximately 110,000 U.S. patients and 87,000 non-U.S. patients received Trasylol. If you or a loved one were given Trasylol and experienced serious complications, such as kidney failure, heart attack, or stroke, contact us today to learn more about your legal rights and options.
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