Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death
(Posted by Tom Lamb at DrugInjuryWatch.com)
An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The Boston Globe informed that the FDA will convene an advisory committee of drug safety experts on September 12, 2007 to discuss Bayer AG's blood-clotting drug Trasylol.
The safety profile of Trasylol has been under FDA scrutiny for more than a year due to case reports which indicate that Trasylol may be associated with kidney damage and heart failure, including some patient deaths. Trasylol is used to reduce blood loss during coronary artery bypass surgery.
In fact, the FDA held a similar advisory committee meeting in September 2006. Thereafter, the FDA required Bayer to add safety warnings to the Trasylol package insert, or label, in late 2006 stating that doctors should only use Trasylol in patients who have an elevated risk of blood loss during surgery.
The FDA advisory committee that is scheduled to meet in September 2007 could recommend more restrictions on when and how Trasylol should be used.
A side story regarding the September 2006 Trasylol advisory committee meeting developed when, following that meeting, Bayer said two employees had withheld some additional information about Trasylol side effects from that the evidence which was presented by the drug company at that meeting. Coincidentally, or ironically, Bayer announced just last week that an outside investigation had concluded these two employees did not intend to mislead the FDA's earlier advisory committee members by withholding that Trasylol side effect information.