Parker Waichman LLP

FDA Trasylol Failure Could Have Killed Thousands, Researcher Says

Trasylol, a defective drug manufactured by Bayer AG, may have killed 22,000 people before it was pulled from the market last year.  Trasylol was withdrawn in November at the request of the Food & Drug Administration (FDA) after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. […]

<"https://www.yourlawyer.com/topics/overview/trasylol">Trasylol, a defective drug manufactured by Bayer AG, may have killed 22,000 people before it was pulled from the market last year.  Trasylol was withdrawn in November at the request of the Food & Drug Administration (FDA) after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. But a researcher who presented a Trasylol study to the FDA in 2006 told the TV program “60 Minutes” that thousands of lives would have been saved if the FDA had acted sooner.

Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol.  In September 2006, Dr. Dennis Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death.   Mangano told “60 Minutes” the he believes Trasylol should have been taken off the market when he published his study in 2006. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.”

Bayer executives attended Mangano’s presentation in order to defend Trasylol.  What they did not tell the FDA was that their own Trasylol study, known as the I3 drug report, confirmed Mangano’s findings.   That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told “60 Minutes” that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,”

But even after learning of the I3 drug report, the FDA allowed Trasylol to remain on the market.  In December 2006, the FDA updated the Trasylol label to include a black box warning – the agency’s strictest safety notice – stating that the drug placed patients at a high risk of kidney failure. Then in September 2007, even while agreeing with the assessment that Trasylol had a high risk of causing fatal side-effects, an FDA advisory panel voted that Trasylol should stay on the market.

It wasn’t until November 2007, when the Canadian Data Safety Monitoring Board had stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. While the patients in the Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group.  Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US at the FDA’s request.

But Bayer still hasn’t given up on Trasylol.   According to “60 Minutes”, the company is still defending Trasylol.  Bayer sent a letter to “60 Minutes” claiming that “the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.”  According to the program, Bayer plans to assess whether Trasylol can be remarketed after further research.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Christina Morace was not only an an amazing expert in helping us navigate thru the required paperwork for the VCF 9/11 Fund claim, she was also so wonderful in helping us get through the emotional toll of this process. She gave us clarity and encouragement for 3 years now. She was truly helpful and very very kind. We ( including my sister who has passed) feel so fortunate to have Tina "on the case", as expert and friend. We are grateful to Tina and the services of Parker Waichman. Thank you so so much. With much gratitude Sharon Carr (deceased) Karen Carr (sister of deceased) Yvette Christofilis (sister-in-law of deceased)
Yvette Christofilis
a year ago
5 Star Reviews 150
Very professional, punctual ,kept me in the loop on everything,helped explain and assist in filling out paperwork.
kevin v
6 years ago
5 Star Reviews 150
In June I had a car accident and I was hesitant to find a lawyer but my family urged me to. I searched the web and asked some co workers for any recommendations. One of my workers said the name Waichman found the web site of Parker Waichman and I called them. The woman who answered the phone was informative and compassionate. By that evening a representative from the law firm was at my home and answered all of my questions. With in the next few days I was contacted by several individual from the firm including a Nurse who continues to contact me on a regular basis to see how my recovery is progressing. I am happy my family convinced me to retain an attorney, I have received hundreds of papers from my insurance company and if I had to sort them out I would be lost. I feel confident that I made the right choice with the firm of Paker Waichman.
Diane Tischer
8 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038