Warner-Lambert Rezulin Drug Linked to About 35 Deaths (Update2)
Bloomberg News
March 18, 1999, 4:57 p.m. ET
Warner-Lambert Rezulin Drug Linked to About 35 Deaths (Update2)
(Adds closing shares. )
Washington, March 18 (Bloomberg) -- Warner-Lambert Co.'s
Rezulin drug for diabetes has been linked to the deaths of about
35 patients, company officials said, citing conversations with
U.S. Food and Drug Administration officials.
FDA officials said the agency will update its official tally
of Rezulin-linked liver damage and deaths at a meeting next week,
and expects to report numbers close to the 33 deaths it reported
in December. The tally may include patients who had to have an
emergency liver transplant and survived.
That's fewer than the number of possible Rezulin deaths
reported in a Los Angeles Times story today. The newspaper said
its review of 155 reports of deaths among patients taking Rezulin
showed about 60 percent of those involved some kind of liver
damage. Twelve liver-related deaths among Rezulin patients have
been reported in the first six weeks of 1999, the Times story
said.
''To the best of our knowledge the number is between 33 and
35 patients,'' said Steve Mock, a Warner-Lambert spokesman. ''I
think the FDA would agree that the incidence of serious liver-
related events has declined since the last label change.''
Mock said only one death has been reported among patients
who started taking Rezulin after the FDA and the company added
more warnings and restrictions to the drug's label in July.
FDA Update
The FDA update will come during a special meeting next week,
where an FDA advisory panel will review the data that has been
gathered on the safety of the drug since its approval.
Reports of deaths among Rezulin patients come from doctors,
nurses and other health care officials who fill them out as part
of the FDA's efforts to monitor the safety of the drugs it
approves. Each report is evaluated to determine whether there is
any link between a patient's death and the drugs he or she was
taking. Some patients had other liver problems that were
unrelated, such as cirrhosis, Mock said.
''You can see the complications with these patients and why
the FDA has difficulty reviewing these numbers,'' he said. ''We
rely on the FDA's evaluation.''
Rezulin is the first in a new class of diabetes drugs,
called glitazones, which help the body to use its own insulin
better. The drug is approved for use in people with adult onset
or Type 2 diabetes, where patients either make too little insulin
or lose sensitivity to the blood sugar regulating hormone. About
15 million Americans have Type 2 diabetes.
Competition
Rezulin could soon face competition as companies move to
introduce new glitazone drugs, such as SmithKline Beecham Plc's
Avandia, and Actos, a Takeda Chemical drug that will be sold by
Eli Lilly & Co. Doctors could see these drugs, which could be on
the market this year, as a safer alternative to Rezulin.
Since Rezulin's introduction in March 1997, its warning
label has been strengthened three times. A black box on the label
-- considered the Food and Drug Administration's strongest
warning measure -- highlights the section on Rezulin's risks.
That label extended the time doctors need to do monthly
monitoring of Rezulin patients for possible liver damage to eight
months from six months.
Even with the ''black-box'' warning, doctors have still been
prescribing the drug. Rezulin's third-quarter sales rose
32 percent to $181 million.
''We can never exclude the possibility of future adverse
events, but the goal is that the label change will be successful
in substantially reducing the risk,'' Mock said. ''There are no
absolutes. The benefits must be weighed against the risks.''
Rezulin was invented by Japan's Sankyo Co. and licensed to
Warner-Lambert in the U.S. and Glaxo Wellcome Plc in Europe.
Glaxo halted sales of its version of the drug last year in the
U.K after at least five people died. Glaxo declined comment today
except to say it is ''in the process'' of seeking U.K. approval
to begin selling the drug again.
Warner-Lambert shares rose 1 1/8 to close at 72 5/8.
--Kristin Reed in Washington (202) 624-1858 / mfr
|
