ROCKVILLE, Md. -- The FDA said Bayer was not forthcoming with data from a retrospective study that suggested Trasylol (aprotinin injection) may increase the chance for death, serious kidney damage, congestive heart failure, and strokes.
ROCKVILLE, Md., Oct. 2 -- The FDA said Bayer was not forthcoming with data from a retrospective study that suggested Trasylol (aprotinin injection) may increase the chance for death, serious kidney damage, congestive heart failure, and strokes.
Moreover, the FDA said -- and Bayer conceded -- that these new data were not reported to the FDA as part of a Sept. 21 public meeting that reviewed the safety and efficacy of the drug.
In a statement on the company's Web site, Bayer said the failure to disclose the new information was "a mistake on the company's part."
Bayer, which is headquartered in Leverkusen, Germany, said it didn't share the data with the FDA's Cardiovascular and Renal Drugs Advisory Committee because the data were "preliminary in nature and raised significant questions about the study population, outcomes, and methodology."
The FDA said it received a tip about the data on Sept. 27 and a day later the agency posted a statement about Bayer's omission on its website.
The FDA has been conducting a safety review of Trasylol since early this year following the publication of a pair of studies in major medical journals. One reported an increase in the chance of renal failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other reported an increase in kidney dysfunction compared to another drug. The Sept. 21 public meeting was part of that review.
The company said it gave a copy of the study to the FDA late last week. It is "analyzing this report, answers received from the questions posed to the investigator, and additionally will work with the investigator and other experts to examine the underlying source data and fully understand the results."
Bayer said it planned to continue to "work closely with the FDA to address questions regarding this study and the overall safety and efficacy of Trasylol."
Trasylol, which is made from bovine lung tissue, slows or prevents bleeding and is commonly used during heart surgery to reduce the need for transfusion.
In the studies published earlier this year and in the recently supplied Bayer study, patients were not assigned at random to receive various treatments, but rather had their treatment chosen by their physician as part of their standard medical care.
Consequently, in these safety studies, patients receiving Trasylol may have had a higher chance for serious complications to begin with compared with patients receiving no treatment or treatment with another drug intended to decrease bleeding.
The FDA said this potential bias complicates the assessment of whether the available studies show that Trasylol treatment, rather than other factors, increased the chance for serious kidney or heart complications.
The new study was done for Bayer by a contract research organization, according to the FDA. Existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery were examined. Thirty thousand of the patients were treated with Trasylol and 37,000 were treated with alternate products.
Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure and stroke.
The FDA said it would evaluate the new data, but meanwhile it advised: