(Adds Bayer comment, drug details)
By Kim Dixon
WASHINGTON, Sept 10 Bayer AG's BAYG.DE heart
surgery drug Trasylol appears to increase the risk of kidney
failure and the risk of death, U.S. regulators said in
documents released on Monday.
A U.S. Food and Drug Administration advisory panel will
once again review the safety of Trasylol on Wednesday,
following emergence of troubling data just days after another
FDA advisory panel met last year over the drug's safety.
That first advisory panel found the drug, used to stem
bleeding and the need for blood transfusions during surgery,
was acceptable for some patients undergoing heart surgery.
German drugmaker Bayer says it mistakenly withheld a study
of 67,000 hospital records suggesting the drug could increase
the risk of death, serious kidney damage, congestive heart
failure and stroke.
FDA staff, in briefing documents ahead of Wednesday's
advisory panel, said the totality of three recent studies
support the risk of renal failure and dysfunction, and noted a
"mortality disadvantage detected" in the Bayer study.
A Bayer spokeswoman said the company looks forward to
discussing the drug's merits at the advisory panel meeting.
The drug, approved in 1993, is given by injection to
prevent blood loss during cardiac bypass surgery. It is the
only FDA-approved drug for that use, though doctors often turn
to two older generic drugs for the same purpose, experts have
Wall Street analysts originally forecast that Trasylol
could generate sales of more than $500 million, but those
estimates have greatly diminished amid the safety issues and
after an FDA label warning was added last year.
"There is still no new clinical data, so the question is
whether (Bayer's) observational study is enough of an alarm,"
said Ira Loss, an analyst at the investor research firm
"My assumption is this drug is being put into the dead-end
of drug land," he added.
Of that withheld Bayer study, FDA staff said that "use of
this study alone would be inappropriate for drawing any firm
conclusions" regarding the drug's safety in coronary artery
bypass graft surgery patients.
Bayer has said it did not share the findings with the FDA
because they were preliminary, though it has suspended two
senior staffers over the issue.
The first FDA panel in September 2006 was reviewing data
from medical journals that suggested the drug might increase
the chance of kidney damage, heart attacks and strokes.
In European trading, Bayer's stock eased 0.44 percent.
The 235 pages of briefing documents for the advisory panel
meeting were released on the Web at: