03/25 10:56 Warner-Lambert drug Rezulin faces scrutiny Friday
By Lisa Richwine
WASHINGTON, March 25 (Reuters) - The fast-selling diabetes drug
Rezulin, linked to serious liver problems and 28 deaths, comes under
scrutiny on Friday as government advisers meet to analyze its safety.
Members of a scientific advisory committee are expected to debate
whether the Food and Drug Administration should expand or restrict
the use of Rezulin, a treatment that hit the market in 1997 and quickly
became the second-best-selling drug for its maker, Warner-Lambert
Co. <WLA.N>.
At the meeting, both the company and the FDA will release their latest
findings of serious reactions and deaths linked to the diabetes pill.
The FDA has repeatedly supported Rezulin despite questions about
its safety. An FDA official who has seen the most recent data on
Rezulin said in an interview she was confident the agency had
handled the drug properly.
"When problems were discovered, we responded rapidly," said Dr.
Janet Woodcock, head of the FDA's Center for Drug Evaluation and
Research. "We put warnings out. Everybody knows about this
problem, and we've been real clear on this case."
After a handful of patients developed serious liver problems and died,
the FDA ordered changes to the drug's label three times. The agency
advised doctors to monitor liver enzymes regularly and discontinue
Rezulin use in patients with signs of serious liver trouble. Patients
taking the drug must have 11 liver tests during the first year.
Meanwhile, Glaxo Wellcome Plc <GLXO.L> withdrew its version of
Rezulin in Europe, and consumer groups called for a ban in the
United States.
Rezulin, which had 1998 sales of $748 million, has now been linked
to about 28 deaths and about seven liver transplants, a
Warner-Lambert spokeswoman said. Even so, the company
maintains the drug, currently used by 750,000 U.S. diabetics, yields
benefits that outweigh its risks.
Rezulin, known generically as troglitazone, is the first a new class of
drugs that helps patients with adult-onset diabetics control blood
sugar by attacking insulin resistance. Some patients report significant
improvements that help them avoid serious complications such as
heart disease and blindness. Warner-Lambert is so sure of the drug
that it will ask the FDA panel Friday to support expanding Rezulin's
use for combination with two other drugs. The FDA usually follows its
panels' advice.
Drug industry analysts said it was hard to predict Rezulin's future
before seeing the latest safety data.
Working against Rezulin, they said, was the British drug approval
agency's denial of Glaxo Wellcome's request to reintroduce its
version of Rezulin there.
But they predicted it would ultimately stay on the U.S. market barring
a flood of new death reports. Most analysts interviewed said they did
not expect any bombshells at Friday's meeting.
"If the FDA had significant concerns about the drug, they wouldn't wait
for this panel meeting," said Madison Securities analyst Sharon
Doering.
The meeting could actually provide a boost to Warner-Lambert,
analysts said, if the company survives the negative publicity with no
changes in Rezulin's status, Doering said. Regardless of Friday's
outcome, the controversy surrounding Rezulin could become moot
later this year when two competing drugs are expected to hit U.S.
pharmacies, experts and analysts said. Clinical trials on those drugs,
SmithKline Beecham's <SB.L> Avandia and Takeda Chemical
Industries' <4502.T> Actos, have shown similar effectiveness without
any liver damage.
"This drug is not going to survive," predicted Dr. Sidney Wolfe, a
consumer advocate who will argue for Rezulin's withdrawal at the
Friday meeting. "Even if it stays on the market, no one is going to
prescribe it if either one of these drugs gets approved."
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