Bayer has been sued over Trasylol, a drug used to prevent bleeding during heart bypass surgery that was withdrawn from the market in May 2008. According to MadisonRecord.com, the lawsuit alleges that Bayer did not warn of the possible serious side effects linked to Trasylol.
Trasylol was approved by the US Food & Drug Administration (FDA) 1993 and, before it was withdrawn, had been used in a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times. In October 2007, the Canadian Data Safety Monitoring Board stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.
Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study was published in a May 2008 issue The New England Journal of Medicine. The analysis found that of the 2,331 people enrolled in the Canadian study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with other drugs – namely Amicar or Cyklokapron – was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for every 50 patients treated with Trasylol.
The latest Trasylol lawsuit was filed in Illinois’ St. Clair County Circuit Court by a man and woman who claim their use of Trasylol led to renal damage, renal insufficiency and multi-system organ failure. According to the complaint, when Trasylol first came to market, Bayer provided no warnings about its link to renal toxicity. The side effect first was revealed in an online “Transfusion” article dated Jan. 20, 2006, according to the complaint. Another study was published in the “New England Journal of Medicine” on Jan. 26, 2006, reporting Trasylol’s association with serious renal toxicity and ischemic events.
That prompted the FDA to take another look at the drug, but an agency advisory panel it warnings on Trasylol did not need to be strengthened. However, according to the complaint, a Bayer-paid study of 67,000 patients had confirmed that Trasylol increased the risk of renal failure, heart attack and stroke, and suggested that those treated with the drug faced an increased risk of death, kidney failure and congestive heart failure. The lawsuit alleges that Bayer knew of these study results, but didn’t disclose them to the FDA. A Harvard researcher who had worked on the study informed the FDA of its findings just after the advisory panel made its recommendation.
In December 2006, the FDA finally did direct Bayer to update the Trasylol label to include a warning that it increases the risk of kidney damage. The revised label also specified that the drug should be given only to patients who are at an increased risk for blood loss and blood transfusion.