Bayer Delayed Report To FDA On Study

Bayer AG failed to immediately disclose to U.S. regulators a study that may underscore serious safety concerns about its antibleeding drug Trasylol.

The Food and Drug Administration said preliminary results of the new study showed that use of the drug may increase the risk of death, serious kidney damage, congestive heart failure and strokes. Some of those results echo two earlier studies about the drug. Trasylol, used by about 150,000 U.S. patients last year, is approved to limit blood loss during coronary-artery bypass surgery.

The FDA said Bayer told the agency about the study, which the company had commissioned from an outside contractor, on Wednesday, nearly a week after the agency held an advisory-committee meeting on the safety of the drug.

Bayer said Friday that it told the agency about the study after an outside researcher, who isn't a Bayer employee, "requested that we inform the FDA." The company said it now "believes that, despite the highly preliminary nature of this data, the information should have been shared with the FDA before the Sept. 21 advisory-committee meeting." It called the failure to disclose it "a mistake on the company's part."

The FDA said it was evaluating the new study, which involved the database records of 67,000 patients. The agency repeated an earlier recommendation that doctors should carefully monitor patients taking the drug and use it only when it is most needed.

Without the Bayer-commissioned study, the FDA committee voted that Trasylol appeared safe and effective. Members of the committee questioned the methodology and downplayed the results of the main safety study that they did review, published in the New England Journal of Medicine and not funded by Bayer.

The history of Trasylol, approved in 1993, may underline worries about the U.S. system for detecting and confirming drug side effects. Companies are supposed to inform the agency about the results of studies they sponsor about their drugs, particularly those with new information relevant to evaluating the drug's safety. The agency has limited resources to do such studies on its own, and its authority to order manufacturers to do them isn't always clear.

In February, the FDA put out a warning about Trasylol, prompted by two published studies. One, in the Jan. 26 New England Journal, found the drug might be linked to a doubling of the risk of kidney failure, as well as increased risk of heart attacks, heart failure and strokes. The authors concluded that "continued use is not prudent." Another study, in the journal Transfusion, also linked Trasylol to kidney damage.