Throughout history, there have been countless stories of drugs that have been developed to help people, but instead end up causing them harm. One such drug is Trasylol, which was used as a blood-clotting agent during surgeries. Trasylol, also known as aprotinin, was approved for use by the US Food and Drug Administration (FDA) in 1993. It was marketed by Bayer as being able to prevent bleeding during a surgery by controlling the enzymes in the body that cause blood to clot. However, recent studies have shown that Trasylol exposure may have serious and potentially deadly side effects.
What is Trasylol?
Trasylol, also known as aprotinin, is a medicine that was approved by the FDA in 1993 to help control blood loss during surgeries. It is a protein that is derived from the pancreas of cows. Essentially, Trasylol works by inhibiting protease, an enzyme that breaks down proteins, including fibrin, which forms clots. By inhibiting the protease, Trasylol was supposed to reduce blood loss by keeping clots from forming during the surgery.
Trasylol was marketed as a safer alternative to other blood-clotting agents because it had a longer-lasting effect. This meant that the patient would need fewer doses during the surgery, which could help reduce the risk of side effects.
The Use of Trasylol in Surgeries
Trasylol was mainly used during surgeries that involved a high risk of blood loss. Some of the surgeries that Trasylol was commonly used for included heart bypass surgeries, liver transplant surgeries, and surgeries that involved the removal of tumors. Surgeons would typically administer Trasylol by injection, and it would start working within a few minutes.
One reason why Trasylol was popular was it appeared to be effective in reducing bleeding and the need for blood transfusions in these types of surgeries. But, it soon became apparent that Trasylol exposure was linked to serious and potentially deadly side effects.
Trasylol Exposure and Side Effects
One of the most significant and deadly side effects of Trasylol exposure is that it can cause kidney failure. Studies have shown that Trasylol can cause acute kidney injury, which can lead to chronic kidney disease. This is because Trasylol can lead to the formation of blood clots in the kidneys, which can block blood flow and damage the organ.
Another side effect of Trasylol exposure is that it can cause heart failure. This is because the drug can cause the heart to pump less efficiently. One study found that patients who received Trasylol during heart surgery were at an increased risk of heart attack and cardiac arrest.
Trasylol exposure can also cause allergic reactions and an increased risk of blood clots. Some patients have experienced anaphylaxis, a severe allergic reaction that can result in difficulty breathing and even death. Trasylol exposure has also been linked to an increased risk of stroke and heart attack, which can be fatal.
Studies Linking Trasylol to Serious Side Effects
The potential side effects of Trasylol exposure were first brought to light in 2006 when a study by Dr. Dennis Mangano revealed that Trasylol was associated with an increased risk of kidney failure, heart failure, and stroke. The study found that patients who received Trasylol during heart bypass surgery were three times more likely to experience kidney failure than patients who did not receive the drug.
After the study was published, the FDA issued a warning about the potential risks associated with Trasylol exposure. Bayer, the company that marketed the drug, also took steps to restrict its use.
In 2008, the FDA held hearings to investigate the safety of Trasylol. The agency ultimately decided to allow Bayer to continue marketing the drug, but with new warning labels that emphasized the potential risks associated with its use. Despite the warnings, some physicians continued to use Trasylol because they believed that the benefits of the drug outweighed the risks.
On May 14, 2008, Bayer announced that it would voluntarily withdraw Trasylol from the market due to the results of a Canadian study, which concluded that patients who received Trasylol had an increased risk of death compared to those who received other treatments. Following this decision, thousands of lawsuits were filed by patients who claimed that they suffered serious injuries or lost loved ones due to Trasylol exposure.
The Fallout from Trasylol Exposure
Since the withdrawal of Trasylol from the market, Bayer has faced numerous lawsuits from patients who suffered serious and potentially deadly side effects after being exposed to the drug during a surgery. The lawsuits claimed that Bayer knew about the potential risks associated with Trasylol but failed to warn physicians and patients adequately.
In 2010, Bayer settled over 3,000 lawsuits for $60 million. In the settlement, Bayer did not admit to any wrongdoing but agreed to pay the plaintiffs who claimed that they were injured by Trasylol exposure. This settlement was just the beginning, and Bayer has continued to settle lawsuits related to Trasylol exposure to this day.
Conclusion
Trasylol was marketed as a safer alternative to other blood-clotting agents used during surgeries, but it soon became apparent that Trasylol exposure was linked to serious and potentially deadly side effects. Studies have linked Trasylol to an increased risk of kidney failure, heart failure, stroke, and death. After a study revealed the potential risks associated with Trasylol, the FDA issued a warning and Bayer took steps to restrict its use.
In 2008, due to the results of a Canadian study, Bayer voluntarily withdrew Trasylol from the market. Following this decision, thousands of lawsuits were filed against the company by patients who suffered serious and potentially deadly side effects due to Trasylol exposure.
Despite Bayer’s efforts to settle, patients who were injured by Trasylol exposure may continue to seek compensation in the courts. In the end, this tragic event serves as a reminder of the importance of rigorous testing and careful monitoring of new drugs before they are introduced to the market.
What is Trasylol?
Trasylol is a drug developed and manufactured by Bayer Pharmaceuticals for use in surgery to prevent bleeding. The generic term, aprotinin, is categorized as a basic pancreatic trypsin inhibitor (BPTI). Trasylol works by slowing down the effects of the fibrinolysis, which is the process by which blood clots begin to break down. The goal of Trasylol was to prevent low blood pressure and lower the need for blood transfusion during heart and liver surgeries. In 2008 the drug was taken of the market after reports began to surface that it was linked to complications and death in patients who were exposed to it.
Side effects
Trasylol has been linked to acute renal failure, myocardial infarction, heart failure, stroke encephalopathy in patients that were injected with the drug. In 2006 the FDA received notice that there were increased risks associated with the use of the drug during surgery but neglected to institute a warning. Subsequent studies in 2008 have shown that the drug, when compared to similar fibrinolysis inhibitors, was 32% to 64% more likely to result in mortality.
Government Regulation
Canada has recently permitted the reintroduction of Trasylol back onto the Canadian market. Those involved stated that when Trasylol is used as directed it is perfectly appropriate and the benefits greatly outweigh the risks. The statements, given by Health Canada, went on to say that Trasylol is intended for use in low risk cardiac bypass surgery but that it became widespread in use for all surgeries and that complications most likely occur with higher risk surgeries. As of this moment the ban in the United States is still active.
Litigation
As of 2007 Bayer had reached settlement with 200 of 2,000 pending cases involving Trasylol and complications leading to kidney failure, heart conditions and death. The average settlement is believed to be between $400,000 and $500,000. Of the 1,600 claims still pending most claim that the Bayer did not properly advise the healthcare community and users of the risks of Trasylol and its relation to serious injury or death. The complaints also allege that Bayer delayed disclosing those results to the FDA and failed to make an adequate warning or recall when it was appropriate.
What to do if you have been exposed to Trasylol?
It is most often found that those who go in for surgery do not know of the medications involved. If you or someone you know is suffering from a kidney or heart condition it is important to consult your physician to discover whether Trasylol was involved in your surgical proceeding. Litigation over Trasylol is ongoing but it is important that you go through the steps necessary to discover if you have a claim. The statute of limitations is running and in these kinds of cases it is often difficult to pinpoint when an individual should have known they were injured. For that reason, if you were exposed to Trasylol it is important that you consult with an attorney who specializes in injury cases of this nature.
