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Drugs designed to control type 2 diabetes should
be subjected to more thorough safety reviews to ensure they don't
raise the risk of heart problems, U.S. Food and Drug Administration
advisers said Wednesday.
The panel of outside experts voted 14-to-2, at
the end of a two-day meeting, to recommend that all makers of these
drugs conduct long-term cardiovascular trials, even if the drugs
show no signs of heart problems in initial trials.
Most of the panel members also said that trials
assessing cardiovascular risk should be done before a drug is
approved; these could be a part of a phase III trial to rule out any
significant heart risk. Long-term trials could follow once the drug
was on the market, the advisers said.
Currently, the FDA only requires that drugs for
type 2 diabetes lower blood sugar, which is thought to protect
diabetics from the debilitating side effects of the disease.
Although the FDA is not required to follow its advisory panels'
recommendations, it usually does.
The panel's vote comes less than a year after the
FDA was harshly criticized for its handling of the type 2 diabetes
drug Avandia (rosiglitazone), made by GlaxoSmithKline. The drug was
approved in 1999, but the FDA added a "black box" warning about an
increased risk of heart attack last November. And the agency decided
to keep Avandia on the market because it concluded that the risk of
heart attack wasn't any higher than that associated with similar
medications.
Dr. Steven Nissen, chairman of the Cleveland
Clinic's department of cardiovascular medicine, first raised
concerns about Avandia and heart attack risk in a study published
last year. He said in November that he welcomed "the addition of a
black box warning for the risk of heart attack from Avandia," but
would have preferred a warning "written with greater clarity," like
the one used by Health Canada, the FDA's counterpart in Canada.
The Canadian label says Avandia is not to be used
as the sole medication for type 2 diabetes except for patients who
can't take metformin, another drug that also lowers blood sugar. The
label also states that Avandia is not to be used by any patient with
heart failure.
The controversy over Avandia started in May 2007,
when a study by Nissen and colleague Kathy Wolski, published in the
New England Journal of Medicine, found a 43 percent increased risk
of heart attack among patients taking the drug. Nissen said he
uncovered the risk after poring over data from 42 studies of Avandia.
On Tuesday, Nissen told the FDA advisers that the
agency should make companies demonstrate that their type 2 drugs do
not increase risks of cardiovascular disease before being approved,
the Wall Street Journal reported.
"Merely lowering blood-glucose levels in diabetes
is too simplistic," Nissen told the panel. "We must reduce the
complications of diabetes, including cardiovascular disease."
Should the agency adopt the panel's
recommendation, the additional clinical trials could add years and
millions of dollars to the development of any new type 2 diabetes
drug. Companies such as Bristol-Myers Squibb and AstraZeneca are
currently working on such drugs, the Journal reported.
An estimated 20.4 million Americans have type 2
diabetes, which can lead to kidney failure, blindness and heart
disease. About 75 percent of diabetics die from cardiovascular
disease.
Sen. Charles Grassley, R-Iowa, is investigating
the FDA's approval of Avandia and the cholesterol-lowering drug
Vytorin, which did not reduce the build-up of plaque in the
arteries.
Recently, the FDA denied approval of another
cholesterol-lowering drug from Merck & Co. The denial sparked
speculation that the agency has tightened its approval standards for
these medications. However, the FDA hasn't said whether changes in
its approval process are being considered, the Associated Press
reported.
SOURCES: U.S. Food and Drug
Administration; The Wall Street Journal; Associated Press
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