Warner-Lambert Diabetes Drug Faces FDA Panel Review Next Week
Bloomberg News
March 18, 1999, 3:37 p.m. ET
Warner-Lambert Diabetes Drug Faces FDA Panel Review Next Week
Washington, March 18 (Bloomberg) -- Warner-Lambert Co., one
of the world's most profitable drugmakers, will defend the safety
of its diabetes drug Rezulin at a special meeting of government
experts next week.
An advisory panel for the U.S. Food and Drug Administration
will review data on the use of Rezulin, which has been officially
linked to liver injuries and at least 33 deaths since it went on
the market in early 1997.
Doctors have continued to prescribe the drug, which had 1998
sales of $748 million, even after the company and the FDA
amplified warnings on Rezulin on three different occasions. The
panel hearing comes amid criticism that the FDA has not been
vigilant enough in policing the drug.
''The FDA is a government agency and it doesn't like being
in the spotlight,'' said Karen Johnson-Grunst, an analyst with
Banc One Investment Advisors, which holds about 3.9 million
Warner-Lambert shares, according to regulatory filings. ''They
could look to tighten up the label even more.''
Warner-Lambert licenses Rezulin, introduced in 1997, from
Japan's Sankyo Co. The drug, along with the cholesterol reducer
Lipitor that Warner-Lambert introduced the same year, turned one
of the least-successful U.S. drugmakers into an industry leader.
The pace of growth could be threatened if concerns about
Rezulin's safety persist as rivals companies introduce new drugs.
The FDA is speeding its review of applications for two Rezulin
rivals, SmithKline Beecham Plc's Avandia and Actos, a Takeda
Chemical drug that will be sold by Eli Lilly & Co. The FDA will
hold panel hearings on these drugs on April 22 and April 23.
Competition
That means Rezulin could face competition from Actos and
Avandia by the end of the year. All three drugs, part of a new
class known as the glitazones, are intended to treat adult onset,
or Type II, diabetes.
About 15 million people in the U.S. now have this disorder,
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.
The FDA said it called the Rezulin panel hearing to ask
experts how it might insure the drug is marketed safely in the
future, not whether it should recall the product.
''If we thought that the benefits of Rezulin were outweighed
by its risks, we would take action right now,'' said Murray
Lumpkin, the deputy director of the FDA's Center for Drug
Evaluation and Research, during a January interview. ''We have
not made that decision.''
Case Reports
Panel members at the day-long meeting next week will hear
from the FDA, the company and the public, and will review reports
of injuries and deaths among patients who took the diabetes pill.
These case reports, filed by doctors, nurses and other
health care professionals, are collected as part of the FDA's
routine efforts to monitor the safety of drugs it approves.
Each report is evaluated by the agency to determine
whether there is any link between a patient's death and the drugs
he or she was taking.
The FDA is expected to present reports of death or liver
transplant in about 35 patients where there is a credible link
between the drug and the injury, Warner-Lambert officials say,
citing conversations with officials at the agency. FDA officials
said the official tally would be close to the 33 deaths it
confirmed in December, but declined to give precise figures.
A key issue for the panel will be whether problems with
Rezulin have declined since additional warnings and restrictions
were placed on Rezulin in response to initial patient deaths. A
black box on the label -- considered the FDA's strongest warning
measure -- now highlights the section on Rezulin's risks.
Friendly Facts
''We think that the facts are friendly,'' said Robert
Zerbe, a Warner-Lambert researcher. ''The risks are no greater
than the alternatives that people with Type II have to choose
from and we can add that the rates of adverse occurrences have
fallen since the label change.''
Only one report has been received of a death where a patient
started Rezulin therapy after the latest changes, Warner-Lambert
said.
Still, doctors likely would welcome glitazone drugs that
seem to have lower risk of side effects, said Bruce Goldstein, a
diabetes specialist at Thomas Jefferson University.
''It's really been hard to convince primary-care doctors to
use Rezulin in a lot of cases because they're afraid their
patients will get into trouble,'' Goldstein said.
Rezulin, though, works very well, said Goldstein. He cited
the particular example of a diabetic woman who did not follow her
diet and couldn't exercise. Rezulin brought her blood-sugar
levels into good control.
''That's a tremendous response that she didn't get with
other medicines,'' said Goldstein.
--Kristin Reed in Washington and Kerry Dooley in Princeton
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