FDA Warning: Trasylol
The FDA (Food and Drug Administration) is responsible for protecting public health by working to ensure the safety of a number of consumer products, including drugs, medical devices, food, cosmetics and more. The FDA serves to regulate the pharmaceutical industry by mandating recalls or warnings regarding particular drugs that have been proven unsafe.
Trasylol was released by Bayer AC in 1993. The drug is developed from a protein found in bovine lung and pancreatic tissue and was created to reduce blood loss during complex surgery, heart surgery in particular.
FDA Warnings and the Recall of Trasylol
The FDA has issued several warnings regarding Trasylol (aprotinin injection). The most recent warning regarding the Trasylol recall can be viewed here . Following is a general timeline of FDA warnings and the eventual recall of Trasylol:
- The FDA began its safety review of Trasylol in January of 2006, following two research studies that indicated the increased risk of kidney failure, heart attack and stroke in patients treated with Trasylol.
- On February 8th of the same year, the FDA issued a Public Health Advisory regarding its findings.
- On September 21st, 2006 the FDA held a public meeting regarding Trasylol, of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety of this drug and the overall benefits versus the risks.
- An FDA warning was issued on December 15th, 2006 that approved revised labeling for Trasylol that strengthened safety warnings and limited its approved usage.
- On November 5th, 2007 the FDA announced that Bayer was voluntarily suspending marketing of Trasylol, due to the findings of a Canadian study that suggested an increased risk of death. This suspension was done upon the request of the FDA.
- Finally, due to a study released in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
Lawyers for Trasylol Lawsuits
A lawyer at Tracey Law Firm can help you if you or a loved one has suffered complications following surgery due to Trasylol. We have the experience as well as the resources to investigate your case, and during a free initial evaluation we may be able to determine whether you have a lawsuit. If so, you may be able to recover financial compensation for your injuries.
Contact a Trasylol attorney at our firm today!
