Dow Jones article:
By Otesa Middleton
WASHINGTON (Dow Jones)--A federal panel will discuss the future of
Warner-Lambert's (WLA) diabetes drug Rezulin Friday.
The U.S. Food and Drug Administration called the meeting earlier this year to
review the safety of the drug, which has been linked to deaths and liver
failure in patients. The panel will also consider Warner-Lambert's application
to have Rezulin's approval broadened, so it can be marketed as part of a
combination regimen with two other diabetes drugs, sulfonylurea and metformin.
Rezulin, which was approved in January 1997, had strong warnings added to its
label in December 1997 after three liver-failure deaths were reported among
patients using the drug.
Last July, the company and FDA agreed doctors need to implement regular liver
monitoring for patients taking Rezulin after there were more deaths and
patients requiring liver transplants.
Since those label changes, there has been much attention on the popular drug,
with media reports and consumer groups saying there have been far more deaths
and liver failures linked to the drug.
Warner-Lambert said that in the U.S., there have been 28 liver-related deaths
and seven liver transplants in which Rezulin can't be excluded as the culprit.
"We will look at the adverse event experience and have a public discussion
about what it means," said FDA spokesman Lawrence Bachorik.
The advisory panel will examine the data and make recommendations to the FDA
about Rezulin, which recorded $748 million in sales last year.
Warner-Lambert To Defend Popular Diabetes Drug
Warner-Lambert spokeswoman Christy Davis said at the panel meeting, the
company will outline what it considers the benefits of Rezulin therapy.
"We are confident in our label as it presently exists," Davis said.
"Questions have been raised concerning the safety of Rezulin, and we want to
address any false, misleading or inaccurate data."
Washington-based consumer group Public Citizen insists Rezulin should be
banned in the U.S. Public Citizen petitioned the FDA last July to have the drug
pulled from the market.
Dr. Sidney Wolfe, executive director of the organization's Health Research
Group, plans to give a 15-minute presentation at the FDA panel meeting.
"The benefits don't outweigh the risks," Wolfe said. "There is no evidence
that it saves people's lives. But it has a much higher death rate than other
drugs, and it shouldn't be around."
Wolfe said the U.S. should follow the lead of other governments that have
banned the drug. For example, Glaxo Wellcome PLC (GLX), which has the rights to
sell Rezulin in Europe, withdrew the drug from the market in the United Kingdom
in December 1997 after consulting with the British health agency. Monday it was
announced that Glaxo's application to resume selling the drug was denied.
Analyst Sees A Recommendation For Stronger Warnings
Pharmaceutical analyst Hemant Shah of HKS & Co. expects the panel to
recommend that the FDA strengthen Rezulin's warnings. Because the meeting was
announced in mid-January, Shah doesn't believe the agency is in a hurry to yank
the drug off the market.
"If the FDA wanted to remove the drug from the market, it wouldn't have
waited for two months while millions of people used the drug," Shah said.
But, because the FDA saw the need to call a meeting, Shah doesn't think the
agency is satisfied with the drug and its label as it is.
Shah said concerns over liver toxicity hasn't put a huge damper on sales of
Rezulin, Warner-Lambert's second-best selling drug, after only the
cholesterol-lowering drug Lipitor.
"There's no question use has slowed down ever since the side-effect issue
emerged. However, sales have not been declining," he said. "It's obviously
benefiting a whole lot of people."
Prem Lachman, pharmaceutical analyst at the Galleon Group, agreed that the
FDA will probably keep Rezulin on the market.
"Basically the meeting is an exercise to review all of the facts," Lachman
said.
However, he doesn't think the panel will recommend more liver monitoring.
"How much more can they do?" Lachman said. Rezulin's label currently calls
for liver enzyme monitoring monthly for the first eight months a patient uses
the drug, every other month for the rest of the first year and periodically
after that.
Lachman doesn't see liver problems as the most formidable threat to Rezulin,
which is made by Warner-Lambert's Parke-Davis unit.
"What will limit the drug's growth will be new competitors," he said. Lachman
mentioned two diabetes drugs with applications pending before the FDA,
Smith-Kline Beecham PLC's (SBH) Avandia, which the same panel will review on
April 22, and Actos from Eli Lilly & Co. (LLY) and Japan's Takeda Chemical
Industries Ltd. (J.TKD), to be reviewed on April 23.
Lachman said the panel will most likely recommend expanded approval for
Rezulin as part of combination therapy, because the drug appears to be safer
when combined with the other treatments.
- Otesa Middleton; 202-862-6654
(END) DOW JONES NEWS 03-24-99
04:39 PM |
