On Thursday December 31, 1998, the United States
Food and Drug Administration approved Celebrex(TM), (generic: Celecoxib) for
the relief of the signs and symptoms of osteoarthritis and adult rheumatoid
arthritis.
Celebrex is a long-awaited treatment option for people suffering with
arthritis. It is the first FDA approved drug in a new class of drugs known as
COX-2 inhibitors. The new drug was created using advanced molecular technology
and it's creators have high expectations for its use. Celebrex works by
inhibiting the COX-2 enzyme which is involved in the pain and inflammation
process. At therapeutic doses Celebrex does not inhibit the COX-1 enzyme which
is involved in helping to maintain the stomach lining. NSAIDS, non-steroidal
anti-inflammatory drugs, inhibit both COX-1 and COX-2 enzymes, therefore they
have the desired effect of treating pain and inflammation but also may damage
the stomach lining and lead to ulcers.
With the development of Celebrex and future COX-2 selective drugs, the intent
is that gastrointestinal side effects associated with existing NSAIDS will be
lessened if not eliminated. Celebrex was tested in clinical trials involving
more than 13,000 patients and healthy persons, including 50 different studies
in 23 countries. Celebrex was demonstrated to be as effective as
prescription-strength Naproxen in treating arthritis pain and inflammation. In
patients with osteoarthritis, Celebrex improved pain, stiffness, and functions
such as walking and bending among others. Celebrex was associated with
significantly fewer upper gastrointestinal ulcers than either Naproxen or
Ibuprofen in clinical studies.
With the approval of Celebrex however, the FDA warned that it is not definite
that Celebrex will cause less gastrointestinal distress than existing NSAIDS.
Long-term studies must be done which show the long-term effect of the drug. For
now Celebrex will carry the same warnings on its label as all other NSAIDS.
In clinical studies, the most common gastrointestinal side effects of Celebrex
included dyspepsia, diarrhea, and abdominal pain. Discontinuing the use of
Celebrex due to each of these was less than one percent. Even though Celebrex
is touted as having less risk for stomach ulcers, serious gastrointestinal
ulcerations can develop without forewarning. Both physicians and patients
should remain aware of symptoms of GI bleeding.
Patients with known allergies to celecoxib, sulfonamides, aspirin, or NSAIDS
should not use Celebrex. The new drug will be available by prescription in
early 1999. The recommended dose for osteoarthritis is 200 mg. daily given as a
single dose or 100 mg. twice a day. For rheumatoid arthritis the recommended
dose is 100 to 200 mg. twice daily.
REFERENCE:
FDA Approves Celebrex For OA and RA, PRNewswire, 12/31/98
