---
Novartis Drug Risk Seen Similar to Vioxx - FDA Staff
Novartis Drug Risk Seen Similar to Vioxx - FDA Staff -- Posted by Roman Bystrianyk on 02-06-05 16:59
http://www.reuters.com/newsArticle.jhtml;jsessionid=LHAXPTNJN2RIWCRBAEOCFEY?type=healthNews&storyID=7545373
Susan Heavey, "Novartis Drug Risk Seen Similar to Vioxx - FDA Staff",
Reuters, February 4, 2005,
Link:
http://www.reuters.com/newsArticle.jhtml;jsessionid=LHAXPTNJN2RIWCRBAEOCFEY?type=healthNews&storyID=7545373
A clinical trial for Novartis AG's experimental painkiller Prexige
showed the risk of heart attack, stroke and death was "similar" to
Merck & Co. Inc.'s now withdrawn Vioxx, U.S. regulatory staff said in
documents released on Friday.
Prexige, which is not yet approved in the United States, showed greater
cardiovascular risks compared to naproxen but similar risks compared to
ibuprofen, Food and Drug Administration staff said.
The trial also showed Prexige had an "advantage" over other pain drugs
that can cause stomach problems.
"Definitely, Target showed a (gastrointestinal) advantage over"
patients taking ibuprofen or naproxen, especially in those who were not
taking aspirin, the FDA reviewers said in their analysis, which was
posted on the agency's Web site.
The documents were released ahead of an unusual three-day meeting later
this month when an FDA panel of outside experts will discuss Prexige,
Vioxx and other similar pain medicines.
Agency officials called for the meeting after a series of warnings
since September over heart problems connected to both prescription and
over-the-counter painkillers.
Novartis spokeswoman Kate O'Connor said it was important to note that
the study did not produce definitive results but she had no comment on
the Vioxx comparison. "I think it's premature to comment on anything
like that," she said.
Some analysts said they were not surprised by the FDA staff's comments
since the agency earlier rejected the drug. "Almost all of this has
been known," said Deutsche Bank analyst Barbara Ryan.
Novartis shares closed down 7 cents at $47.84 on the New York Stock
Exchange on Friday.
When the FDA rejected Prexige in 2003, it said it wanted to see
complete results of a two-part trial called Target.
One part of the Target trial, which followed about 18,000 patients for
52 weeks, showed 40 cardiovascular-related problems, including 11
deaths, in patients who took Prexige, compared with 27 problems,
including 8 deaths, in naproxen patients.
FDA staff said those findings "are consistent with findings for Vioxx,"
the arthritis drug Merck pulled from the market in September after a
study showed it raised the risk of heart attacks and strokes. Both
drugs are part of a class called Cox-2 inhibitors.
A second arm of the trial found 19 cardiovascular reactions, including
eight deaths, with Prexige compared to 21 reactions, including 10
deaths, with ibuprofen.
Naproxen and ibuprofen are part of a group of medicines called
non-steroidal anti-inflammatory drugs, which can cause ulcers and other
gastrointestinal problems.
"This study has not definitely answered the question whether
lumiracoxib (Prexige) increases cardiovascular thrombotic risk compared
to non-selective NSAIDs," the staff wrote.
Novartis has said it may refile for U.S. approval in 2007. Prexige is
approved in Britain and 20 other countries, but the company pulled its
application for wider EU approval in November, saying it would provide
more data.
In other FDA documents released Friday, FDA staff questioned Merck's
newer painkiller called Arcoxia, which they said showed "marginal"
advantage over stomach problems but seemed to be worse than other pain
drugs regarding deaths and serious cardiovascular problems. (Additional
reporting by Ransdell Pierson in New York)
Related
Discussion:
rezalution.net (1 posts)
by Timothy M. Reza - Last post on: 12-20-03 11:04
Find your resolution today with Rezalution Enterprises...
Don't change your lifestyle to fit your health needs. We have products and
information that will easily fit into the life you already have. Surf your
way over to our site and read about what we have to offer. Our site is easy
to navi... (Read More)
Heart Disease Drops Among Diabetics (1 posts)
by Gumbo - Last post on: 12-17-04 19:10
Heart Disease Drops Among Diabetics
Although diabetes remains a significant risk factor for cardiac problems,
there has been about a 50 percent decline in the incidence of heart disease
among adult diabetics over the past several decades, according to a new
study.
A team led by Dr. Carol... (Read More)
Re: FREE Info on HEAlth and WEAlth (1 posts)
by Paul T. Holland - Last post on: 04-27-05 11:40
why it's Alan Kuykendall, the lying mlm scam spammer, here once again! what a
silly little con man he is to return after already being spanked once for his
pathetic con game... just a reminder, here was his first foray:
http://makeashorterlink.com/?O5C7129FA that was when he made illegal cla... (Read More)
Gout (3 posts)
by muffster - Last post on: 07-25-04 05:58
I am looking for a newsgroup for people suffering from gout but cannot find
such a site . can anyone tell me if there is one i can participate in?
thanks ,
Keith
... (Read More)
Top
Discussions From Our Archives
[site-of-the-day] Your Disease Risk
Painkillers linked to heart failure
Shu Li
Other
Discussion Categories
Diabetes Symptoms
Health Care Policy
Health Care Providers HMO
Arthritis Symptoms
| 
