Antibleeding Heart Bypass Drug
Faces Another FDA Safety Review

- Wall Street Journal

09/10/2007 - A Bayer Pharmaceuticals drug used to control bleeding in patients undergoing heart bypass surgery will face a second safety review by a Food and Drug Administration panel Wednesday.

The drug, Trasylol, has been the subject of an ongoing FDA safety review since two studies published in 2006 suggested the drug doubled the risk of kidney failure. Since then, two additional studies have suggested the drug also could increase the risk of death.

Last December, the FDA updated its strictest black-box warning on Trasylol, stating that it could increase risk of kidney damage and that it should be used only in certain situations in which patients are at an increased risk for blood loss during heart bypass surgery. That decision followed a FDA panel meeting in September 2006.

One of the newer studies, known as the I3 drug report, had been given to Bayer shortly before last September's meeting, but the company didn't submit the findings until after the panel meeting. Bayer has said that it didn't intentionally keep the results from the panel and that senior management wasn't told the report was in until after the FDA panel met.

The FDA said in documents posted to its Web site Monday that the major purpose of this September's advisory committee meeting is "to provide recommendations about the overall risk-benefit assessment for Trasylol, especially when considering the information that was not provided to the 2006 advisory committee."

The agency didn't release the specific list of questions it would ask the advisory committee.

Preliminary results from the I3 drug study found that Trasylol increased the risk of death by 54%, the FDA said. However, the FDA said the study alone shouldn't be used to determine if the use of Trasylol is safe.

The agency said Bayer recently submitted final results of the I3 study, and an agency review of those results is continuing. Earlier this year, another study published in the Journal of the American Association, suggested the drug also increased the risk of death by about 50% for a certain group of patients. That study was a follow-up to one of the 2006 studies that showed a doubling of kidney failure among patients receiving Trasylol.

The FDA said it would ask the panel about the strengths and limitations of the new studies, which are considered observational and not controlled clinical trials, when considering the overall risks and benefits of the drug.

Bayer, in documents also posted to the FDA's Web site, said it did appear the drug was associated with "renal dysfunction," or kidney problems, but said the product did not appear to be associated with an increased risk of death.

The company said Trasylol "is an important part of blood conservation programs' during heart bypass surgery.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.