Diabetes & Byetta

Diabetes drugs to get ‘black box’ warning
FDA to require notice of heart failure risks on labels of Avandia, Actos

Updated: 8:48 a.m. ET June 7, 2007

WASHINGTON - The Food and Drug Administration will require tougher
warnings about heart failure on the diabetes drugs Avandia and Actos,
FDA Commissioner Andrew von Eschenbach said at a congressional hearing
Wednesday.

Von Eschenbach revealed that the FDA is ordering GlaxoSmithKline to add
a “black box” warning to Avandia and ordering Takeda Pharmaceuticals to
do the same for its competing diabetes drug Actos, strengthening
existing warnings about a condition in which the heart does not
adequately pump blood. The issue is separate from an analysis in the New

England Journal of Medicine that said Avandia increased the risk of
heart attack.

The concerns about Avandia prompted some Democratic lawmakers to rebuke
the Food and Drug Administration and call for increased regulation of
the pharmaceutical industry.
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The controversy intensified when a medical expert told the House
Committee on Oversight and Government Reform that executives threatened
to sue him in 1999 when he first drew attention to heart attack risks
linked to Avandia.

Rep. Henry Waxman, D-Calif., who chairs the committee, lambasted the FDA
for not alerting consumers sooner about the drug’s potential dangers.

“Despite additional warnings from outside experts, despite the millions
of patients who rely on Avandia to control their blood sugar, and
despite the potential risks involved, FDA never required the
manufacturer to conduct a thorough post-market study of its heart
risks,” Waxman said.

Most serious warning
Waxman called Wednesday’s hearing after the New England Journal of
Medicine’s analysis released last month concluded Avandia could raise
patients’ risk of heart attack by more than 40 percent.

Von Eschenbach told Congress his agency is still reviewing dozens of
often contradictory studies and analyses on the drug’s effects on
diabetics. FDA has scheduled a July 30 meeting to have a group of
outside experts look at the data.

But he caught Glaxo executives by surprise when he revealed news of the
labeling change, though the company said it would comply. The tougher
warnings, outlined in a so-called “black box,” are the most serious a
drug label can bear.

“It wasn’t our understanding that they had come to a final conclusion on
this issue, but if they have then obviously we’ll make the change,” said
Chris Viehbacher, president of Glaxo’s U.S. pharmaceuticals business.

The British drug maker argues that Avandia is safe and that its own
patient studies are the most reliable measure of the drug’s safety,
although outside experts say the company’s results are inconclusive.

‘Call off the dogs’
Dr. John Buse, who is soon to become president of the American Diabetes
Association, told lawmakers that after he drew attention in 1999 to
heart problems among some patients using Avandia, SmithKline Beecham,
which later combined with GlaxoWellcome, warned him that some executives
wanted to hold him accountable for a $4 billion drop in the company’s stock.

In a letter to SmithKline distributed at the hearing, Buse wrote:
“Please call off the dogs. I cannot remain civilized much longer under
this kind of heat.”

Buse, who is head of endocrinology at the University of North Carolina,
said he eventually signed a clarifying statement with the company that
was used to ease concerns from investors. But one year later, Buse sent
a letter to the FDA raising the same concerns.

Glaxo said in a statement: “We regret if, at any time, Dr. Buse felt the
conduct of any employee was contrary to the spirit of open, scientific
debate.”

More than 6 million people worldwide have taken Avandia or a related
drug, Avandamet, since it came on the market in 1999. Glaxo reported
total U.S. sales of $2.2 billion for the drug last year.

For its part, Glaxo released the most recent results from a large-scale
study of Avandia ahead of the hearing, saying the data show the drug is
no more dangerous than other leading diabetes drugs.

The Senate recently passed a version of a bill that makes major changes
to FDA’s drug safety system. Companion legislation has not yet appeared
in the House, though Waxman and other Democrats said they favor giving
FDA more power to require companies to conduct drug safety studies.

This entry was posted on Wednesday, March 28th, 2007 at 10:34 pm and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.