German drug maker Bayer AG "mistakenly" failed to inform U.S. regulators about a study on the risks of heart-surgery drug Trasylol before an advisory panel met and ruled the side effects were acceptable, the company said on Friday.
Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21 advisory committee meeting ... This was a mistake on the company's part
The Food and Drug Administration said the early findings from a new review of hospital records from 67,000 patients suggested Trasylol use may increase the chances of death, serious kidney damage, congestive heart failure and strokes.
The agency said it was reviewing the data to decide how they would impact current advice to limit Trasylol use to cases in which doctors believe reducing blood loss during bypass surgery is essential and outweighs possible risks.
The company said it did not share the information with the FDA immediately because there were questions about the study methodology and the findings were preliminary.
"Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21 advisory committee meeting ... This was a mistake on the company's part," a Bayer statement said.
The advisory panel ruled Trasylol provided acceptable safety and effectiveness for preventing blood loss in certain patients undergoing heart bypass surgery.
The FDA sought the panel's opinion after two other studies published in medical journals linked Trasylol use to kidney problems. One of them also said the drug could increase the chances of heart attacks and strokes as well.
The agency said it was unaware of the new study at the time the panel deliberated. Bayer told the FDA about the findings on Wednesday, six days after the public panel meeting, an agency statement said.
The new study was commissioned by Bayer and compared records from 30,000 patients treated with Trasylol to 37,000 treated with other products, the FDA said.
Like the earlier published studies, the new research looked at patients who were not randomly assigned to receive various treatments. That complicates the assessment of whether Trasylol or other factors contributed to kidney or heart complications, the FDA said.
"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 agency said of the new study.
"FDA is actively evaluating these new data and their implications for appropriate use of the drug," the FDA added.
Doctors should watch Trasylol patients for signs of toxicity, particularly to the kidneys, heart or central nervous system, the agency advised.
Bayer said it was analyzing the preliminary findings as well as answers to questioned it posed to the researcher who did the study. The company said it would work with the researcher and other experts "to examine the underlying source data and fully understand the results."
Sales of Trasylol, known generically as aprotinin, were 75 million euros ($95 million) for the first half of 2006. In December 2005, Bayer predicted the drug's annual sales could reach more than 500 million euros ($633 million).
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