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Warner-Lambert Shares Fall Over Rezulin Concerns (Update5)
Bloomberg News
March 26, 1999, 3:38 p.m. ET
Warner-Lambert Shares Fall Over Rezulin Concerns (Update5)
(Adds Warner-Lambert comment, updates shares)
Bethesda, Maryland, March 26 (Bloomberg) - Warner-Lambert
Co. shares fell as a government scientist voiced concern about
the risks of Rezulin, the diabetes drug that helped make it one
of the world's most profitable drug companies.
An advisory panel to the U.S. Food and Drug Administration
is to decide this afternoon whether the drug, linked to 38 cases
of death or liver damage, is safe enough to keep on the market
and if further restrictions on its use are warranted. Warner-
Lambert shares fell 2 17/32 to 66 13/16 in late trading.
''It all comes down to whether the benefits outweigh the
risks,'' said Mike Krensavage an analyst with Brown Brothers
Harriman with a ''strong buy'' recommendation on Warner-Lambert
shares. ''The FDA statistician certainly made a case that there
are some risks to using the drug.''
Further restrictions could benefit U.K. drugmaker SmithKline
Beecham Plc and Japan's Takeda Chemical Industries, which are
seeking FDA approval for competing drugs in the same new class,
called glitazones, for adult onset, or type II, diabetes.
Takeda's drug would be marketed by Eli Lilly & Co.
Rezulin's warning label has been strengthened three times
since its introduction in 1997 and Warner-Lambert officials said
today they would make the warnings even stronger to keep persons
with liver problems from using it.
FDA scientist David Graham said warning label changes and
increased monitoring of Rezulin patients have so far not been
sufficient to reduce risks of liver damage. In some cases, liver
damage has progressed so rapidly that monthly monitoring would
not detect it, he said.
Low Risk
Researchers and officials from Warner-Lambert presented data
suggesting less danger than Graham's review indicated.
''The data show the risk is low and comparable to other
available treatments'' for diabetes, said Robert Zerbe, senior
vice president of clinical research at Parke-Davis, the Warner-
Lambert division which developed the drug. The rate of liver-
related death and transplants is about 1 case in every 57,000
patients who took Rezulin, the company said.
To further reduce the risk, the company will add more
warnings to Rezulin's label, widening the pool of patients who
shouldn't take the drug to include anyone with a history of liver
problems, or a history of alcohol abuse, Zerbe said.
Warner-Lambert will also work to refine the trial period for
the drug so that patients who aren't benefiting from Rezulin stop
taking it, and add information inside the drug's packaging so
that patients are better informed about the importance of having
their liver checked, Zerbe said.
A New Era
Panel members, including diabetes specialists, said an
evaluation of Rezulin needed to take into account the risks posed
by diabetes itself. The risk of death among diabetes patients is
about 1 in 30 a year.
Doctors from nine diabetes centers, treating thousands of
patients, defended Rezulin for making a dramatic impact in their
ability to help some diabetics. Rezulin works in a different way
than other diabetes therapies, making the body more responsive to
lower levels of insulin.
''The advent of Rezulin opened a new era for us,'' said
Ramachandiran Cooppan of the Jocelyn Diabetes Center in Boston.
'' It addressed a fundamental defect in the disease.''
Warner-Lambert today presented conclusions from a number of
studies which indicate that the drug may improve cardiovascular
health in diabetic patients, and improve the functioning of
certain cells which play a role in the disease.
Warnings Not Sufficient
Rezulin, developed by Japan's Sankyo Co., has been
prescribed for about 1.6 million people, according to Warner-
Lambert.
The drug has been deemed the ''probable'' cause of death or
serious liver damage in 38 diabetes patients, according to the
FDA's most up-to-date account, released today. Of the 12 patients
who survived their liver damage, seven needed a liver transplant.
Graham said a patient taking Rezulin would have a risk of
liver failure that is 1,000 times the normal rate of 1 case of
liver failure per million people in the U.S., he said.
Monitoring the drug's risk is complicated by the silent and
rapid onset of liver problems in some patients, Graham said.
''We can't point to monitoring and say this intervention has
had an impact on the rate of liver failure,'' said Graham, with
the FDA's office of postmarketing drug risk assessment.
Some patients degenerated from normal liver functioning to
irreversible damage within four days, he said. That could mean
that monitoring patients liver health every month still might not
reliably protect patients from liver failure, Graham said.
''That is relatively new information,'' said Alex Zisson, an
analyst with Hambrecht & Quist. ''That is the type of information
that could lead to the drug being withdrawn from the market''
once comparable drugs become available, he said.
Already, the FDA is speeding its review of applications for
SmithKline's Avandia and Takeda's Actos. All three drugs, part of
a new class known as the glitazones, are intended to treat adult
onset, or Type II diabetes.
Warner-Lambert had 1998 sales of Rezulin of $748 million,
accounting for 7 percent of its $10.2 billion in total sales.
About 15 million people in the U.S. now have Type II
diabetes, where the body doesn't produce enough insulin to
control blood-sugar levels. Glitazones help the body better use
its own supply of insulin, reducing the need for insulin
injections in some patients.
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