Last week Canadian researchers stopped a study on Trasylol because they believed that the drug increased the risk if death compared to other antifibrinolytic drugs used in the study.
Today the FDA recommended that health care providers review the risks and benefits with their patients when deciding to use Trasylol or discontinue its use.
Antifibrinolytic drugs are used to slow the breakdown of blood clots and any subsequent bleeding. While the data suggested that patients receiving the drug has fewer serious bleeding events, it also noted the increased risk of death.
There have also been accusations that an initial report, prior to Trasylol's FDA approval, had been withheld that indicated the increase risk of death, kidney damage, congestive heart failure and stroke. Bayer claims to have mistakenly withheld that report and attempted to shift blame to the research company that had been contracted to do the initial research on the drug.
The FDA will further review the risks and benefits of Trasylol which may results in label strengthening or other regulatory action.
[Source: FDA]
» Bayer from PharmaGazette
Bayer, the German based company logged in at 10th in R&D and 11th in over all sales for 2006. Canadian researchers stopped a study on Trasylol because of the risk of death but Bayer received FDA supplemental New Drug approval for... [Read More]
Tracked on: December 12, 2007 1:26 PM | Permalink to Trackback