Trasylol Lawyer & Attorney : Fields Law Firm : Trasylol Injury, Kidney & Heart Failure

As the results of more studies are published, the evidence is continuing to show the problem of Trasylol kidney failure following heart surgery. Patients and families around the country are filing Trasylol lawsuits as the public becomes more aware of Bayer’s heart surgery drug side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery.

In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients. This study was followed by an increasing number of Trasylol studies that confirmed the findings of the 2006 NEJM study.

Trasylol studies increasingly show that the drug causes serious problems in bypass patients. In 1993 Trasylol, also referred to as “Aprotinin”, was approved by the Federal Drug Administration (FDA). Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects until late in 2007 when Bayer finally withdrew their heart surgery drug from the market.

Most bypass heart surgery patients are unsure if they were given Trasylol during their open surgery. Many patients suffering from Trasylol kidney failure or stroke side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to use the drug to help prevent excessive bleed loss during surgery.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery. Trasylol is primarily used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug had been in use for 13 years and a million patients had received it before Bayer withdrew it from the market after growing evidence of serious side effects.

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Trasylol, an expensive medication given to heart surgery bypass patients during their surgical procedure to help prevent excessive bleeding may have caused staggering numbers of heart failure, kidney failure and strokes. Patients undergoing cardiac surgery were unaware that Trasylol, a medication manufactured by Bayer, has been found in clinical studies to lead to greater risk of death, stroke, and acute kidney failure.

If a patient was found by their surgeon to be at risk of excessive bleeding during surgery the patient had no way of knowing Trasylol had been found to be not only dangerous but extremely expensive compared to the generic alternatives.

Trasylol Bypass Surgery Alternative Drugs Available

A New England Journal of Medicine study reported that two other generic medications were available that are safer and less expensive than Trasylol.
Heart surgery medications that help prevent excessive bleeding during surgery:

• Trasylol cost per dose is $1,300
• The generic aminocaproic acid cost per dose is $11
• The generic tranexamic acid cost per dose is $44

The generic heart surgery drugs were revealed to be far less costly with no increased risk of heart attack, stroke or kidney failure.

For more information, please visit our Trasylol class action lawsuit website.

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In March 2008 the New England Journal of Medicine published an editorial – Learning from Aprotinin – Mandatory Trials of Comparative Efficacy and Safety Needed. They concluded the problems that have surfaced regarding Trasylol are going to be repeated in other drugs unless the FDA institutes changes in the requirements of postmarketing studies and restrictions on drug distribution and use. The magnitude of Trasylol side effects and the potentially fatal consequences that have affected tens of thousands of heart surgery patients are becoming more and more apparent.

Trasylol (aprotinin) was first approved by the FDA in 1993 to help in reducing blood loss during bypass surgery. It is estimated that by 2006, around 200,000 heart surgery patients had been prescribed aprotinin. Dr. Dennis Mangano and a group of researchers raised a red flag in 2006 and 2007 regarding the safety of Trasylol. Dr. Mangano published an observational study that showed Trasylol increased the risks of kidney failure, heart attack, stroke and death. The New England Journal of Medicine, in their editorial, asked the important question “What can we learn from the saga of aprotinin, a drug that apparently confers less overall benefit than cheaper alternatives yet has remained on the market for more than 14 years and become the recommended hemostatic agent for high-risk cardiac surgeries?”

A vital piece of the drug approval and monitoring process that is missing, according to the editorial, is the requirement for more information on infrequent but serious complication and performance relative to alternative drugs. They state that the key lesson to be learned from the current Trasylol problems is that there needs to be head-to-head comparative trials when a new drug has alternatives. This needs to be done before a drug such as Trasylol is routinely administered for a large number of patients. Furthermore, they state that we cannot rely on the drug manufacturers to perform these studies on a voluntary basis because it is not in their commercial or financial interest to do so.

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