Trasylol – Renal Failure
Techmeier Law Firm is representing plaintiffs pursuing claims against Bayer, the manufacturer of the drug Trasylol, also known as Aprotinin, on behalf of Wisconsin residents who have suffered renal failure requiring dialysis after cardiac surgery.
Trasylol is a drug used to control bleeding and limit the need for blood transfusions in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery. Several studies have linked Trasylol to a nearly doubling of the risk of kidney failure resulting in the need for dialysis. Because Trasylol is administered intravenously after the patient is under anesthesia, patients are unaware that they have received this dangerous drug. Techmeier Law Firm is representing Wisconsin clients who suffered kidney failure resulting in dialysis after having heart surgery.
These damages against Bayer is the first in what is sure to be a wave of litigation that follows the release of several studies that link the use of Trasylol with numerous deadly side effects including stroke, heart attack, and kidney failure resulting in the need for dialysis. The litigation also follows news that Bayer did not disclose the findings from its own research to the FDA that confirmed the drug increased the risk of these serious side effects.
The study, conducted at Bayer’s request, examined the hospital records of 67,000 patients undergoing CABG procedures. About half of these patients received Trasylol while the other half received one of the cheaper, safer alternatives (one dose of Trasylol can cost upward of $1,400). The study suggests that the patients who received Trasylol were at an increased risk for death, kidney failure, heart attack, and stroke. Bayer had received the results of the study at the time of the FDA advisory board committee meeting held to discuss the safety of the drug, yet failed to mention the study’s existence or it’s results.
If you or a loved one suffered renal failure requiring dialysis after cardiac surgery, kindly contact the defective drug lawyers at Techmeier Law Firm.
According to a report on 60 Minutes, the delay in taking Trasylol off the market after the publication of Dr. Dennis Mangano’s groundbreaking study showing elevated risks of kidney damage (including dialysis), heart attack, and stroke may have cost 22,000 lives. Dr. Mangano estimates that as many as 1,000 people per month died as a result of the use of Trasylol during CABG surgery from the publication of his article in January 2006 until the drug’s withdrawal in November 2007.
If you or someone you care for has taken Trasylol, contact me, Milwaukee defective drug lawyer, Will Techmeier immediately, for your free, confidential consultation. I am here to help you and your loved ones.
WEDNESDAY, Jan. 25 (Health Day News) – A widely promoted drug used to prevent bleeding during heart surgery doubles the risk of kidney failure and increases the risk of heart attack, heart failure and stroke, a study finds.
Two less expensive generic drugs used for the same purpose do not carry the same dangers, said a report in the Jan. 26 issue of the New England Journal of Medicine.
The study looked at data on 4,374 patients who had surgery after heart attacks and is “the largest study yet done,” said Dr. Dennis T. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit organization, and lead author of the report.
It compared the outcomes of operations in which patients undergoing coronary artery surgery were given either one of three drugs to reduce bleeding: aprotinin, the newer agent; aminocaproic acid; tranexamic acid; or no drug at all.
The incidence of kidney failure in patients who got aprotinin was more than double that of those who got either of the two other drugs or no drugs at all, the report said. The risk of stroke was 181 percent higher, while the incidence of heart attack or heart failure was 55 percent higher.
The study was done because previous, smaller trials indicated an increased risk associated with aprotinin, but none of them was large enough to be definitive, Mangano said.
Aprotinin was approved by the U.S. Food and Drug Administration in 1993. It is marketed by Bayer HealthCare under the brand name Trasylol.
A statement from Bayer said it “has only just become aware of this observational study” and has not yet reviewed its findings. But the company said the reported increases in risks “are not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug.” Bayer said its claim of safety was based on controlled trials including almost 6,500 heart-surgery patients.
Mangano countered by saying those studies looked at the effectiveness of the drug, not at its safety. “There is no financial incentive for the drug industry to do safety trials after approval,” he said.
And a study looking at safety “would find it very difficult to enroll patients,” Mangano said. “You would be telling patients they would get a protein that promotes kidney failure.”
The fact that aprotinin is a protein, while the other drugs are different chemically, could account for the reported kidney damage, he said. A protein is taken up by the kidney, where it remains for 24 hours and can change kidney function, Mangano said. He estimated that 10,000 Americans now require artificial kidneys because they were given aprotinin.
The Bayer statement said the new study was not the kind of randomized, controlled trial that is “the accepted standard for the safety and efficacy of drugs.”
In an accompanying editorial in the journal, Dr. Gus J. Vlahakes of Massachusetts General Hospital said that “regulatory requirements and the desire to ensure approval often dominate the design of clinical trials.”
The desire to get a drug approved quickly often leads to selection in trials of patients who are least likely to have adverse reactions, said Vlahakes, who is chief of cardiac surgery at the hospital. But once a drug is approved, the company is free to push for expanded uses, he said.
The new study shows the need for continued testing of drugs after their first approval, Vlahakes said. “This process of phase 4 testing [after approval] I think is very important and something the FDA might want to require,” he said.
In the case of aprotinin, Bayer has proposed its use for all heart-surgery patients, saying the drug can prevent an inflammatory reaction often caused by use of a heart-lung machine during the operation, Vlahakes said. The results of the study “are a strong suggestion that you can’t just put aprotinin in the repertoire for all patients,” he said.
At Massachusetts General Hospital, heart-surgery patients are generally given one of the older drugs, with aprotinin used “only in select circumstances where we expect to have particular difficulty with bleeding,” Vlahakes said. Experience has shown that half the recommended dose is fully effective, he said.
Trasylol News Articles and Updates
- Bayer HealthCare – Public Communication – Health Canada Endorsed – Canada NewsWire (press release), Canada – Mar 30, 2007 – Trasylol® is a drug injected during heart bypass surgery to help reduce bleeding and the need for blood transfusions. – Trasylol® should only be used …
- Heart drug warning – Orlando Sentinel, FL – Feb 27, 2007. According to a study published in the Journal of the American Medical Association, the drug Trasylol was linked to a 48-percent increased chance of dying in …
- Costly bypass medication may raise death risk later – Asbury Park Press, NJ – Feb 20, 2007. The Food and Drug Administration approved Trasylol for use in coronary bypass surgery patients in 1993. Last year, it was used 246000 times in the US, …
- Lakeland, Haven Hospitals Don’t Use Anti-Bleeding Drug Aprotinin – The Ledger, FL – Feb 9, 2007 – Aprotinin, also called Trasylol, is one of several drugs that can be used to prevent excessive bleeding during open-heart surgery. …
- Bypass Drug may Raise Death Rate – WFIE-TV, IN Feb 9, 2007 – Nearly 21 percent of people who received aprotinin (Trasylol) died within five years of their surgery, compared to about 13 percent of those who didn’t …
- Heart Surgery Drug Raises Death Risk, Study Finds – FOX News – Feb 7, 2007 – The researchers said replacing the drug – aprotinin, sold by Bayer AG under the brand name Trasylol – with other, cheaper medications for a year would…
- Bayer’s Heart-Surgery Drug Increases Risk of Death – Newsinferno.com, NY – Feb 7, 2007 – Bayer’s controversial heart-surgery drug aprotinin, marketed as Trasylol, is under fire yet again thanks to a new study that found that the drug carries …
- Heart surgery drug hikes death risk for 5 years – Feb 6, 2007 – Aprotinin joins the painkiller Vioxx, drug-coated stents and other drugs and devices where safety concerns arose after the products were on the market. “We don’t know enough about what happens with drugs and devices once they go into the public …
- Trasylol Clinical Trials Halted – Newsinferno.com, NY – Jan 27, 2007 – Bayer Health Care announced it is discontinuing three clinical trials for their drug, Trasylol, citing recent FDA-approved label changes. …
- Bayer Discontinues Trasylol® Clinical Trial Program In Non-CABG Indications – Medical News Today (press release), UK – Jan 26, 2007 – Bayer HealthCare has decided to end three ongoing clinical studies investigating the safety and efficacy of Trasylol® (aprotinin injection) on transfusion …