Glaxo SmithKline Avandia
Diabetes drug linked to liver troubles
By Maggie Fox, Health and Science Correspondent
WASHINGTON, Jan 18 (Reuters) - Two people taking a new kind of diabetes drug
may have had serious liver reactions to the drug, researchers said on
Tuesday, resurrecting worries that the whole class of drugs may be very hard
on the liver.
The patients were taking Avandia, SmithKline-Beecham Plc's version of a new
class of drugs aimed at helping the body's natural insulin work better.
Writing in the Annals of Internal Medicine, Robert Diamond of the University
of Pennsylvania said both patients showed signs of liver poisoning, and
recovered after they stopped taking the drug.
Avandia, known generically as rosiglitazone, is related to another diabetes
drug called Rezulin, whose use has been restricted after it was found to
cause liver damage in some patients.
In June, the U.S. Food and Drug Administration told doctors they should limit
their prescriptions of Rezulin, made by Warner-Lambert Co.'s Parke-Davis
division under the generic name troglitazone, after 28 people who took it
It was linked to at least 12 other cases of liver failure in the more than
1.4 million patients with Type II, or adult-onset diabetes, who had used it
at the time.
SmithKline spokesman Brian Jones said the company had checked both cases
reported this week and did not think Avandia was to blame.
``In an analysis of the general population of people with diabetes you'd
expect to see hepatitis (an inflammation of the liver) or jaundice,'' he said
in a telephone interview.
``It could be hepatitis, gallstones, other drugs they were taking. At this
time there have been no reports of liver failure or liver-related deaths or
transplants that we believe are attributable to Avandia.''
He said one patient had a history of alcoholism, which can damage the liver,
and another may have had blocked blood flow to the liver caused by arterial
disease. But Diamond's team said in their report they did not think the
arterial disease had caused the second patient's problem, and the first
patient had not consumed alcohol for some time.
Susan Cruzan of the FDA said the agency had received other reports of
possible liver toxicity involving Avandia, but she could not say how many.
``We have not seen anything that would cause concern for patients,'' she
said. ``We haven't seen anything associated with Avandia that would raise
questions at this point.''
Launched in the United States in 1997, Rezulin was the first of a class of
diabetes drugs known as thiazolidinediones or glitazones which help boost the
effects of insulin.
Doctors had hoped they could be given to people showing the first symptoms of
adult-onset or type-II diabetes to prevent the condition, but trials of
Rezulin for prevention of diabetes were stopped and Glaxo-Wellcome Plc, which
licensed Rezulin from Parke-Davis, withdrew the drug from sale in Europe.
Cruzan said doctors prescribing any drugs in the class are told to closely
monitor their patients' livers.
``I think the whole class is under intense scrutiny,'' Jones said. ``But we
remain confident in Avandia being safe and effective.''
The FDA said both Avandia and a related drug, Eli Lilly & Co.'s Actos,
appeared to have a safer profile than Rezulin.
In October, the European Union's Committee of Proprietary Medicinal Products
(CPMP) delivered a ``negative opinion'' on Avandia, but said its qualms were
not related to potential liver toxicity.
Earlier this month SmithKline said Avandia had sold one million prescriptions
in the United States in its seven months on the market.
``It's been used in over 350,000 patients,'' Jones said.