FDA Strengthens Warning on Heart Surgery Drug

(Page 2)

In addition, there is a new adverse reaction section on the label that is based on Bayer's review of its global database, Rieves noted. "There is also an alteration of the dosage and administration section to carry over the emphasis on the risk for renal dysfunction and to more clearly describe the dose-administration procedures," he said.

These changes follow an extensive FDA safety review, which began in January and was followed by an FDA public health advisory issued on Feb. 8.

The review was based on the results of two studies. One found the possibility of kidney failure, heart attack and stroke in patients treated with Trasylol compared with those treated with other drugs. The other found an increase in kidney damage, compared with other drugs, but did not find an increased risk of heart attack or stroke.

The new label recommendation were made after a public meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee held on Sept. 21 to consider changes to the drug's label.

A week after that, Bayer informed the FDA of new study data on Trasylol that showed the drug could increase a user's chances of death, serious kidney damage, congestive heart failure and stroke.

The study involved 67,000 patients who had undergone coronary artery bypass graft surgery. At the time, the FDA said it was unaware of the new information.

More information

For more on Trasylol, head to the FDA.