Trasylol Suspended Amidst Controversy
Bayer Pharmaceuticals Corp. issued a worldwide suspension of the production and marketing of Trasylol on November 5, 2007, following increased evidence of a heightened risk of death. Trasylol has been on the market for more than 14 years, during which time it has been one of Bayer’s more profitable drugs. Although the suspension is considered to be a temporary action, there is the potential for a recall of the drug if further evaluation confirms the adverse effects of Trasylol.
Trasylol is the brand name for aprotinin, a type of protein that can be used during major surgery (such as heart bypass surgery) to limit patient bleeding. Trasylol inhibits the natural process by which blood clots are broken down, allowing for prolonged coagulation and reduced bleeding. Excessive bleeding during complex surgeries is often associated with serious complications, including dangerously low blood pressure and organ damage.
The ability of Trasylol to enhance blood clotting and limit the need for blood transfusions during complex surgical procedures made it an instant hit within the medical community. Experts believe that Trasylol has been used in approximately one-third of all heart bypass operations performed in the United States since 1993.
The Trasylol controversy gained momentum following studies linking the drug with an increased mortality rate. One such study involved 10,000 patients given Trasylol during heart bypass surgeries performed between 1996 and 2005 at Duke University Medical Center.
The results of the study, published in the New England Journal of Medicine, determined that approximately 640 of the 10,000 Trasylol patients died within one month of their bypass surgery. One year after surgery, this number climbed to approximately 1,600 patient deaths. These figures become even more alarming when compared with those evaluating patients who underwent bypass without receiving Trasylol. The bypass patients who received Trasylol had a mortality rate roughly two and a half times greater than patients who received an alternative drug or nothing at all during surgery.
Bayer responded to the aforementioned study by funding one of its own, which evaluated 78,000 patients treated with Trasylol over a three-year period. The internal Bayer study compared the mortality rate of Trasylol patients with that of patients being treated with a comparable drug. According to the Bayer study, patients treated with Trasylol had a mortality rate approximately 64 percent higher than patients treated with an alternative drug.
Although Trasylol studies are ongoing, the FDA requested a voluntary suspension of production and marketing of the controversial drug. Bayer maintains that the benefits of Trasylol outweigh the risks, and contends that the suspension is temporary. Currently, there are no plans to recall the drug.
The FDA has been working with Bayer and a number of independent study groups and medical researchers to assess the safety of Trasylol. Their involvement has helped with the enforcement of a Trasylol suspension, though some researchers believe that the FDA has acted negligently.
The initial studies linking Trasylol with serious complications surfaced in 2006, nearly two years before the FDA put pressure on Bayer to suspend production and marketing of the drug. Some estimates have suggested that this slow response time by the FDA could be responsible for more than 20,000 Trasylol-related deaths. While these allegations have not been proven, they have certainly raised eyebrows and placed increased scrutiny on FDA officials.
Trasylol and 60 Minutes
Trasylol received additional media attention after a segment ran in February 2008 on CBS’s news program, 60 Minutes. The program revealed that more than 22,000 deaths could have been prevented had the FDA reacted more quickly to issuing a Trasylol recall.
After Dr. Dennis Mangano published a study about the adverse reactions of Trasylol in the New England Journal of Medicine, Bayer Pharmaceuticals commissioned an internal study, which found similar results. During a meeting with the FDA in September 2006, Bayer failed to divulge the results of these studies, causing the FDA to issue a suspension as opposed to a mandatory recall. Dr. William Hiatt, a Chairman for the FDA Advisory Panel, stated that had he known of the results of the internal study, he would have voted to remove Trasylol from the global market. The negative publicity is attracting criticism to the FDA, as well as the ethics behind Bayer Pharmaceuticals, one of the largest drug manufacturers in the world.
If you or a loved one has been injured as a result of a Trasylol injection, you may be entitled to receive compensation for your medical bills, pain and suffering, and other damages. Drug manufacturers are responsible for evaluating the safety and efficacy of their products before marketing them. Failure to do so render them liable for any injuries or deaths caused as a result.
The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. The lawyers and staff representing Aylstock, Witkin, Kreis and Overholtz are adept at dealing with a wide variety of injuries caused by various product defects and manufacturer negligence. Contact the defective drug attorneys at Aylstock, Witkin, Kreis and Overholtz today at (844) 794-7402 for additional information regarding your rights as a Trasylol injury victim.