What We Do
Defective Medical Products
- Medicines
- Accutane Lawsuit
- AMO Complete Moistureplus Recall
- Apothecure Colchicine Lawsuit
- Baxter Heparin Recall and Lawsuit
- Bismacine Chromacine
- Botox
- Carbinoxamine
- Chromium Poisoning (Toxicity)
- Colchicine Recall Lawyer
- Colistimethate Lawsuit Lawyer
- Edetate Disodium
- Fentanyl
- Fentanyl Patch Recall
- Fentora
- Fleet Lawsuit - Phosphate Nephropathy
- Fosamax Osteonecrosis Jaw
- Ketek Liver Failure
- Ortho Evra Birth Control Patch
- Promethazine
- Rocephin Death
- Selenium Poisoning (Toxicity)
- Topical Anesthetic
- Total Body Formula Recall and Lawsuit
- Trasylol and Kidney Failure
- Trasylol - Lawyer and Lawsuit
- Trasylol Recall
- Tysabri Lawsuit - No Recall
- Zelnorm Heart Attack Stroke Lawsuit
- Medical Equipment
- Medtronic Defibrillator Leads
- Medtronic Lawsuit
- Medtronic Lawyer
- Guidant Recalls
- Free Guidant Recall Consultation
- Guidant Ancure
- Guidant Lawsuit Recall
- Guidant Pacemaker Defibrillator Defect
- Guidant Pacemaker Recall
- FDA Pacemaker Defibrillator Statement
- Infusion Pump
- FDA Recalls
- News & Topics
- Archives
Welcome to Pritzker | Ruohonen
Trasylol Recall - FDA Suspends Marketing of Trasylol (Aprotinin)
The following information on the Trasylol recall is provided by the law firm of Pritzker | Ruohonen & Associates, a leading personal injury law firm with extensive experience representing people with kidney damage. The firm is actively investigating cases involving kidney damage and the use of Trasylol. The firm has a national reputation, and attorneys at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA and other publications. Fred Pritzker and Rich Ruohonen have been named "Super Lawyers" by Law & Politics magazine. To contact a lawyer at the firm about the Trasylol recall, Trasylol kidney damage and a Trasylol lawsuit, please call toll-free at 1-888-377-8900, email Fred Pritzker (lead attorney for the Trasylol cases), or submit the firm's free case consultation form.
FDA Requests Marketing Suspension of Trasylol (Trasylol "Recall")
November 5, 2007 - The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. [This is essentially a Trasylol recall.]
FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.
The FDA Trasylol "recall" discussed above and related issues was the subject of a recent piece that appeared on the CBS news program, 60 Minutes.
If you need a Trasylol lawyer for a Trasylol lawsuit, contact us.
Free Case Consultation
Firm News
Fred Pritzker Listed in The Best Lawyers in America
Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.
Pain and Suffering
Rich Ruohonen recently chaired a legal seminar on obtaining compensation for pain and suffering in a personal injury case. Rich uses his knowledge, experience, and reputation to maximize recoveries for clients.
Medtronic Recall and Medtronic Lawsuit
FDA has annonced a Medtronic Spring Fidelis defibrillator lead recall. Two of our clients with defective Medtronic leads were shocked over twenty times before medical professionals were able to turn off the defibrillator.
Fleet Lawsuit
We are representing several people who experienced kidney failure (acute phosphate nephropathy) after use of Fleet Phospho-soda solution or Fleet Accu-Prep solution for bowel cleansing.
Ortho Evra Lawsuit: Ortho Evra Birth Control Patch
The Ortho Evra birth control patch has been linked to an increased risk of blood clots that can lead to pulmonary embolism, stroke and heart attack.
Trasylol Recall
Bayer has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Fentanyl Lawsuit and Fentanyl Recall
There have been a number of recalls regarding fentanyl due to the risk of a fentanyl overdose.
Fosamax and Osteonecrosis
Several cases of bisphosphonate-associated osteonecrosis of the jaw have been associated with the use of oral bisphosphonates, including Fosamax®, Actonel®, and other medications.
