Warner-Lambert Drug's Benefit Found to Outweigh Risk (Update3)
Bloomberg News
March 26, 1999, 6:58 p.m. ET
Warner-Lambert Drug's Benefit Found to Outweigh Risk (Update3)
(Adds post session trading.)
Bethesda, Maryland, March 26 (Bloomberg) -- Warner-Lambert
Co.'s Rezulin passed a safety review, leaving on the market the
diabetes pill that made the company one of the world's most
profitable drugmakers.
Rezulin has benefits that outweigh its risks when used in
combination with other diabetes drugs, said a panel advising the
U.S. Food and Drug Administration.
The panel's finding could ease worries from doctors and
investors that the FDA might restrict Rezulin sales. Still,
concern over Rezulin's risks, linked to at least 38 cases of
death or serious liver damage, could speed acceptance of
competing drugs U.K. drugmaker SmithKline Beecham Plc and Japan's
Takeda Chemical likely will introduce in the U.S. this year.
''The drug could have some changes in the label, but it will
still be available,'' said Robert Flamm, an analyst with
Evergreen Funds, which holds about 200,000 Warner-Lambert shares.
''There are two other drugs coming along. That will be the real
challenge.''
Warner-Lambert shares rose 5/32 to 69 1/2 in post-session
trading, after falling 1 21/32 to 67 11/16 at the close of
trading on U.S. markets.
The FDA asked the panel to review Rezulin's safety record
because of reports of liver damage and deaths. The drug,
developed by Japan's Sankyo Co., has been prescribed for about
1.6 million people, Warner-Lambert said.
Warner-Lambert had 1998 sales of Rezulin of $748 million,
accounting for 7 percent of its $10.2 billion in total sales.
Along with Warner-Lambert's cholesterol reducer Lipitor, Rezulin
turned the company from one of the least successful drugmakers
into one of the most profitable.
The FDA will hold panel hearings April 22 and April 23 on
the SmithKline and Takeda drugs, part of the same new class of
drugs as Rezulin.
Let Market Decide
''I am hopeful that one or more of those won't be liver-
toxic,'' said Glenn Braunstein, a panel member and director of
the department of medicine at Cedars-Sinai Medical Center in Los
Angeles. ''Then we will let the market decide which is the better
drug.''
The committee did not vote on what further restrictions
should be placed on Rezulin. Several panelists, though, advised
that the drug's use be limited to patients who cannot control
their diabetes with other drugs. Panel members also advised that
patients and doctors be better educated about the side effects
possible with the drug, and said the company and the FDA should
continue to collect data to help determine who is most at risk.
The panel earlier determined, by a vote, that Rezulin's
risks outweigh its potential for benefits when patients take the
drug alone, and said it shouldn't be used by itself. About 2
percent of diabetes patients on a single-drug therapy take
Rezulin.
Warnings Called Insufficient
Rezulin's warning label has been strengthened three
times since its introduction in 1997. 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.
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.
Additional Warnings
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 liver
monitoring, Zerbe said.
Further restrictions on Rezulin could benefit SmithKline and
Takeda as they seek FDA approval for competing drugs in the same
new class, called glitazones, for adult onset, or type II
diabetes.
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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