On December 29, 1993, Trasylol (aprotinin injection) was approved by the FDA as an effective drug for controlling bleeding during heart surgery. Despite growing evidence that Trasylol significantly increased the risk of kidney failure, heart attack, stroke, and death, Bayer Pharmaceutical marketed Trasylol aggressively until it was taken off the market in November of 2007.
By the time it was suspended, Trasylol was used in at least 17 countries and administered to nearly one third of all cardiac bypass patients in the United States. But as far back as 2006, Bayer Pharmaceuticals Corp. and the FDA had access to separate medical studies showing a significant increase in kidney failure and in-hospital death for surgery patients who were given Trasylol.
A study already in the FDA’s possession indicated that thousands of patients had already died. At that time, Bayer failed to inform the FDA that their own study confirmed those concerns as well. So rather than remove Trasylol from the market in 2006, the FDA strengthened its label to include stronger warnings (the seventh label revision since the drug’s approval) and limited its usage to “specific situations.”
Research over the next two years continued to show liver damage, heart attack, and stroke in patients to whom Trasylol was administered. But in September of 2007, an FDA panel still suggested keeping the drug on the market. Less than a month later, a Canadian study of clotting drugs was terminated because Trasylol was putting those patients’ lives at too much of a risk to continue.
After years of warning signs through both practice and study, the FDA finally requested that Bayer stop marketing Trasylol on November 5, 2007. Bayer complied, but continues to refer to the drug’s removal as a “temporary market suspension” and has implied that Trasylol’s benefits may still outweigh its risks.
In February of 2008, a CBS News’ 60 Minutes investigative special entitled “One Thousand Lives A Month” examined the near two-year delay between the FDA’s knowledge of Trasylol’s deadly risks and their removal of the drug from the market. Renown researcher Dr. Dennis Mangano, who authored the original Trasylol study, spoke with CBS correspondent Scott Pelley. By taking Trasylol off the market when it first had the facts, Dr. Mangano estimated, the FDA could have prevented the deaths of 22,000 additional patients in the drugs last two years.
What is Trasylol?
Trasylol (aprotinin injection) is a clotting drug manufactured by Bayer Pharmaceutical Corp. of Germany. It is used to reduce blood loss and blood transfusions needed during heart surgery.
When was Trasylol marketed and administered?
Trasylol was approved by the FDA on December 29, 1993. It was withdrawn from the market on November 5, 2007, when a Canadian study was halted due to risk of death. In January 2008, the FDA approved a “Special Access Protocol” allowing Bayer to distribute the drug to surgeons (“Investigators”) operating on high bleeding-risk patients who have no alternative options.
What are Trasylol’s risks?
Trasylol has been associated with and documented as significantly increasing the risk of:
- Kidney failure (leading to other organ failure)
- Heart attack
How long have Trasylol’s dangers been known?
The FDA was alerted of the risks in 2006. Bayer withheld a second report, which would have corroborated the first report strongly enough to warrant a recall. When a 2007 study was called off because it became too risky for the participants to continue, the FDA finally took action. In early 2008, two additional reports were released as further support of the previously documented results.
How many people died?
It is unknown exactly how many people died because of Trasylol. It has been estimated that Trasylol killed 22,000 people in the last two years of use alone. By the end of its 14 years on the market, Trasylol was used in 1/3 of heart surgeries done in the United States.