Trasylol NEWS: May 15, 2008.

Bayer AG to remove remaining supplies of its heart-surgery anti-bleeding drug Trasylol from the U.S. market.

The Food and Drug Administration said on Wednesday Bayer had notified the agency that it would begin removing remaining Trasylol stock from the U.S. market. Access will be limited to investigational use for certain patients who have no acceptable alternatives, the FDA said.

The FDA "supports Bayer's decision to completely remove Trasylol from regular use in the U.S. market," the agency said.

Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee commented by saying, ""Thus, in all likelihood, this is the end of the aprotinin story."

Bayer said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs.

The drugmaker "will work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol," Bayer spokeswoman Staci Gouveia via email.

UPDATE: November 5, 2007: Bayer Pharmaceuticals HALTS SALE OF TRASYLOL:

Bayer Pharmaceuticals has stopped all US sales of its anti-bleeding drug Trasylol.

Bayer Pharmaceuticals created Trasylol to aid doctors during a complicated and elaborate procedure called coronary artery bypass graft surgery, or CAGB.  These elaborate procedures involve a large risk of dangerous bleeding, and Trasylol helps control excess amounts of blood loss.  Trasylol helps prevent the natural way the body breaks down blood clots, which in turn allows doctors the freedom of time to work without worrying about hemorrhaging. Excessive bleeding is one of the most dangerous conditions, but after such elaborate procedures as CAGB it can be fatal.  

The January 25, 2006 issue of the New England Journal of Medicine reported on a study that revealed that Trasylol 4,374 coronary bypass artery graft patients suffered twice the risk of renal failure and stroke and also a 55% increase in occurrences of heart failure or heart attack. Furthermore, despite the arrival of several low cost generic drugs that are more effective and less dangerous, many doctors still continue to use Trasylol in CAGB procedures.

In order to educate and inform the public about the dangers of Trasylol, The Food and Drug Administration warned doctors on February 9, 2006 to restrict Trayslol use in CAGB procedures because of the danger of likelihood of kidney damage and heart trauma.  Despite the evidence that generic drugs could reduce the occurrence of renal failure by 9,000 to 11,000 patients, Bayer AG maintains that the FDA and the New England Journal of Medicine are contrary to the 15 years of data they collected on their own.

If the side effects of Trayslol caused you or someone you love to experience negative health consequences, you need to consult a knowledgeable and compassionate defective drug attorney today.  You need to act quickly; because the statute of limitations in your state could end you case before it has a chance to begin. Don’t let your opportunity for justice pass you buy. Contact a lawyer today.