| Roman Bystrianyk 2005-08-02, 11:45 am |
| Ransdell Pierson, "Pfizer's Celebrex arthritis drug to add warnings",
Reuters UK, August 1, 2005,
Link:
http://today.reuters.co.uk/news/new...H-PFIZER-DC.XML
Pfizer Inc. on Monday said the label of its Celebrex arthritis drug has
been changed to add a prominent warning of possible cardiovascular
risks, such as an increased chance of heart attacks, in line with new
warnings on other arthritis and pain drugs.
The label will also carry a new warning that Celebrex, like older
painkillers, can cause serious ulcers and gastrointestinal bleeding.
Celebrex was developed to treat pain with less risk of such bleeding
than older treatments. But in a large clinical trial, Celebrex failed
to prove significantly safer for the stomach than two far-cheaper
standard painkillers.
Pfizer said the package insert label of the drug now recommends it be
prescribed "at the lowest effective dose for the shortest duration."
The label will now also note that Celebrex more than doubled the risk
of heart attack in a 3-year cancer-prevention trial sponsored by the
federal government, although it did not show such danger in a similar
cancer-prevention study.
But the company on Monday also said U.S. regulators had approved a new
use for the drug, treating ankylosing spondylitis, a form of arthritis
of the spine that Pfizer said affects more than 400,000 Americans.
"The fact that the FDA gave us a new indication shows they are
confident in the safety of Celebrex," said Pfizer spokeswoman Mariann
Caprino.
Celebrex has been one of the company's biggest products, though its
sales have recently declined sharply due to safety concerns.
Second-quarter revenue from Celebrex plunged 45 percent to $401 million
-- one reason the world's largest drug maker expects a modest decline
in company revenue this year.
A federal advisory panel of doctors in February said Celebrex
"significantly" raised the risk of heart problems and strokes. But the
advisers to the U.S. Food and Drug Administration recommended it remain
on the market because of its benefits to arthritis patients.
Pfizer is adding the new "black box" warnings at the request of the
FDA. The agency has also asked the makers of dozens of other
prescription and nonprescription painkillers -- including Motrin, Advil
and Aleve -- to strengthen warnings about possible heart risks and
potentially life-threatening gastrointestinal bleeding. The new
heart-risk warnings do not apply to aspirin.
New York-based Pfizer in April withdrew a similar arthritis drug,
Bextra, after U.S. and European regulators said the risk of side
effects, including a potentially fatal skin allergy, outweighed its
benefits.
Pfizer last month said its sales forces was holding back on fully
promoting Celebrex again until it knew the warning language the FDA
would require on the drug's label.
Safety concerns about Celebrex and other painkillers intensified after
Merck & Co. Inc. withdrew its Vioxx arthritis treatment in September
when it was shown to double the risk of heart attack and stroke after
long-term use.
Celebrex and Vioxx both work by selectively blocking an
inflammation-causing protein called Cox-2; but in doing so, some
scientists believe the drugs also increase the risk of blood clots that
cause heart attacks and stroke.
Pfizer shares closed up 14 cents at $26.64 on the New York Stock
Exchange, in line with slight gains for the drug sector.
|