Recalled Heart Surgery Drug Trasylol Allowed Back on Market in Canada

Canadian health officials are allowing the recalled heart surgery drug Trasylol back on the market in the country, but stress that it should not be used for off-label purposes. 

Health Canada announced on September 21 that it was permitting Trasylol to return to use in Canada, more than three years after a Trasylol recall pulled the drug from the U.S. and Canadian market after it was suspected of being a factor in thousands of deaths due to kidney failure, heart attacks and strokes.

While reports suggest that there could have been more than 20,000 Trasylol deaths caused by the drug, Health Canada determined that the benefits of the drug, which is approved to prevent excessive bleeding during heart surgery, outweigh the health risks.

The agency’s own evidence indicated that there was no increased risk of death from Trasylol as long as it was used solely for low risk heart surgery. The increased chance of death appears to be linked to off-label use of the drug, Canadian officials said.

Originally, Trasylol was approved for low-risk cardiac bypass surgery, but doctors later began to use it in higher risk heart surgeries, where the drug appears to have increased the risk of death instead of increasing the chances a patient survived.

Trasylol (aprotonin) was administered to an estimated 4.3 million patients in the hospital prior to heart surgery, but most people were not specifically aware of the name of the drug or that they were given it at all. Therefore, many of the families of individuals who died following heart surgery with Trasylol were never aware that the death may have been caused by the medication.

Originally approved by the FDA in 1993, concerns about Trasylol problems first gained national attention in early 2006, when preliminary data from a study suggested that the drug increased the risk of serious kidney damage, congestive heart failure, strokes and death. After adding strong warnings to the drug, Bayer ultimately suspended sales in November 2007 and recalled Trasylol in May 2008, after an aborted study found it increased the risk of death by over 54% compared to alternative drugs to control bleeding.

Bayer faces hundreds of Trasylol lawsuits, involving allegations that the drug maker failed to exercise the proper degree of care in designing and testing the drug, and that it did not properly alert healthcare professionals and users to the risks of Trasylol side effects. Although the drug maker was aware of negative study results, some of the complaints allege that they delayed disclosing the data to the FDA and failed to issue adequate warnings. Bayer has reached Trasylol settlements with some plaintiffs.