ROCKVILLE, Md., Jan. 4 /PRNewswire/ -- FDA has approved Celebrex
(Celecoxib), a new product to treat rheumatoid arthritis and osteo-arthritis.
Celebrex is an NSAID or non-steroidal anti-inflammatory drug that blocks
production of prostaglandins by inhibiting the enzyme cyclooxygenase-2 (Cox-
2). The following may be used to respond to questions:
Arthritis affects millions of Americans -- more than three million with
rheumatoid arthritis, and 16 million with osteoarthritis, the most common form
of arthritis affecting the elderly. Both cause painful inflammation and joint
deterioration.
Unlike other NSAIDS, Celebrex does not inhibit the enzyme cyclooxygenase-1
or COX-1. Inhibition of COX-1 is believed to contribute to some of the
adverse effects of NSAIDS, including upper gastrointestinal ulcers. It is
therefore hoped that Celebrex will have safety advantages compared to other
NSAID products. Additional studies and post-marketing experience will add
substantially to the understanding of how the overall risks and benefits of
Celebrex compare with those of other NSAID products.
Celebrex was found to be an effective arthritis treatment in placebo and
active-controlled clinical trials that enrolled 2100 patients with rheumatoid
arthritis and 4200 patients with osteoarthritis.
Celebrex was compared to other NSAID products in several of these clinical
trials by using endoscopes (a device to examine organs of the gastrointestinal
tract) to determine the incidence of stomach and upper intestinal ulcerations
following the use of these products. These studies showed that patients
taking Celebrex had a substantially lower risk of ulcers detected by endoscopy
over the study period of 12 to 24 weeks compared to patients who took other
NSAIDS.
However, NSAID products can cause a range of gastrointestinal problems,
and patients with endoscopic ulcers may often recover without special
treatment and without experiencing any serious symptoms or complications.
Therefore, additional studies in many thousands of patients would be needed to
see whether Celebrex actually causes fewer serious gastrointestinal
complications than other NSAID products. Until such studies are done, the
drug labeling for Celebrex will include the standard warning for doctors and
their patients about the risks associated with all NSAIDS, including risks of
GI ulceration, bleeding and perforation. The labeling advises patients taking
these drugs to be alert for ulceration and bleeding that can occur with or
without warning. Patients should promptly report signs and symptoms of
gastrointestinal ulceration or bleeding, skin rash, unexplained weight gain,
or swelling to their physicians.
In addition, Celebrex does not affect platelet aggregation (clumping) an
important part of the blood clotting process. Many other NSAID products can
interfere with this platelet function, which may increase the risk of bleeding
complications in some patients. However, Celebrex does not appear to be
different from other NSAIDS in its effects on the kidneys.
Celebrex is manufactured by Searle of Chicago, Illinois.
SOURCE Food and Drug Administration
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301-827-6242, Broadcast Media: 301-827-3434 or Consumer
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