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Celebrex against Juvenile Rheumatoid Arthritis

December 15, 2006 - The U.S. Food and Drug Administration -

Celebrex (celecoxib) received the approval from the U.S. Food and Drug Administration to be used as the treatment of Juvenile Rheumatoid Arthritis (JRA), according to the FDA official press release, dated December 15, 2006. Celebrex, which was initially approved in 1998 as the medication to relief pain, swelling and stiffness, associated with osteoarthritis and rheumatoid arthritis, can now be used for treating JRA symptoms in patients two years of age and older.

The decision to widen the range of Celebrex application was made during the recent meeting of the FDA's Arthritis Advisory Committee on November 29, where the majority of votes were given in favor of the Celebrex approval.

The approval follows the 24-week study of Celebrex in treating the Juvenile Rheumatoid Arthritis. In general, 242 patients between the ages of 2 and 17 years participated in the study, which showed the effectiveness of Celebrex in treating JRA symptoms. The study also reported the most common side effects, associated with the medication use, such as cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea and vomiting.

In the nearest future two more studies will be conducted to reveal the influence of Celebrex on the high blood pressure and long-term post-marketing study to evaluate other safety issues, such as renal toxicity, high blood pressure, and cardiovascular events. Both of these studies will be conducted by the manufacturer of the drug, Pfizer Inc.

About Celebrex Celebrex or celecoxib by generic name belongs to the class of pain relievers and anti-inflammatory agents, called COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatory drugs). This is a newer class of medications; unlike the older NSAIDs, celecoxib does not cause gastrointestinal side effects, such as stomach irritation, gas or stomach ulcers. This is achieved by more precise selectivity of the medication: Celebrex affects only COX-2 enzyme that regulates pain and inflammation and does not interfere with COX-1 enzyme, participating in the protection system of the stomach.

Since the approval in 1998 Celebrex has been prescribed for more than 30 million people in the USA to relieve joint pain and swelling, manage acute surgery pain, treat painful menstrual cramps and relieve the symptoms of ankylosing spondylitis, a painful form of arthritis, primarily affecting the spine.

About Juvenile Rheumatoid Arthritis Juvenile Rheumatoid Arthritis (JRA) is a disease, causing chronic inflammation of the joints and internal organs in children. The exact cause of the JRA is still unknown, but the scientists believe that it is the autoimmune disease, triggered by some viral infections. The disease usually begins between ages 2 and 5 or 9 and 12. The JRA is characterized by joint stiffness in the morning, fever with no apparent cause, swelling and pain in the joints.

There are three types of JRA, but the most serious is the systemic JRA, when the internal organs are affected along with the joints. About 30-50 % of systemic JRA cases result in joint deformity and functional limitations.

Treatment of the Juvenile Rheumatoid Arthritis is usually directed toward reducing the inflammation, pain, and swelling of the joints.

Thanks to the FDA approval Celebrex can now be prescribed to treat JRA symptoms in children, effectively reducing pain and inflammation, and at the same time causing no adverse reactions in the gastrointestinal system.

Nick

External resources
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01530.html
http://www.celebrex.com/about/about.jsp?setShowOn=../about/about.jsp&setShowH...
http://www.amazon.com/American-Medical-Association-Complete-Encyclopedia/dp/0...
http://www.amazon.com/Pill-Book-12th/dp/0553588923/sr=8-1/qid=1166730205/ref=...