NEW
Warnings Added to Diabetes Drugs
WASHINGTON,
April 26 — GlaxoSmithKline and Eli Lilly & Company have
added warnings about heart and liver risks to the labels of their
diabetes drugs, which are similar to a medication that was
withdrawn from the market in 2000 because of links to fatal liver
damage.
The
Food and Drug Administration posted information today about heart
and liver risks in Glaxo's drug, Avandia, and in Actos from Lilly,
although warnings were added to the labels earlier.
The
F.D.A. posted a summary of risks associated with the medicines on
the Medwatch area of its Web site (www.fda.gov) to inform doctors
and the public.
Doctors
have been watching for signs of liver damage in patients on
Avandia and Actos since their introduction in the United States in
1999 because they work the same way as Rezulin, the diabetes
medicine that was withdrawn.
GSK’s
Response: Millions of
diabetics now take the drug Avandia in an effort to lower their
blood sugar. It is believed to be far safer than the first drug of
its class, Rezulin, which was blamed for nearly 60 deaths due to
liver failure before being pulled from the market two years ago.
Now
a review conducted by Avandia manufacturer Glaxo SmithKline,
offers the best evidence yet that the newer drug does not cause
liver problems. Researchers analyzed the results of 22 clinical
trials, involving more than 5,000 diabetes patients, and found no
evidence of drug-related liver complications. The study was
reported in the May issue of the American Diabetes Association
publication Diabetes Care.
"Because
this study involved such a large number of people, it provides
fairly conclusive evidence that [Avandia] is safe to use,"
says lead author Harold E. Lebovitz, MD, of New York's SUNY Health
Science Center at Brooklyn. Lebovitz is a paid consultant for
Glaxo SmithKline.
Avandia
and Actos, a similar drug made by Takeda Pharmaceuticals, are two
of the most commonly prescribed treatments for type 2 diabetes.
Like Rezulin, Avandia and Actos are insulin regulators belonging
to a class of drugs known as glitazones. But unlike Rezulin, no
deaths or serious liver injury have been reported in users of the
two newer drugs.
In
this study, liver function measurements were reviewed for just
over 5,000 diabetes patients participating in studies of Avandia.
The drug was given either alone, or in combination with other
insulin-regulating therapies. Lebovitz and colleagues report no
evidence of liver toxicity among the patients, and many patients
actually had improvement in liver function with treatment.
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