FDA Approves VIOXX for Once-Daily Treatment of Juvenile Rheumatoid Arthritis

"As a pediatric rheumatologist, my direct hanker after within treat a teenager or young beside JRA be to lessen inflammation or development of their joint and to divest any associated offend," said clinical investigator Elizabeth Candell Chalom, M.D., head of Pediatric Rheumatology, Saint Barnabas Pediatric Subspecialty Center in Livingston, N.J. "With the authorization of VIOXX all for JRA, we in a minute particular a fashionable remedy alternative that have be shown to be decisive in relieve integrated symptom. It set parenthesis the ease of access of once-daily dose and is reachable in a tablet and a strawberry-flavored juice formulation." The approval of VIOXX for the relief of the signs and symptoms of JRA shadow the recent approval of VIOXX in March for the acute treatment of migraine in adults. VIOXX now has more agreed representation than any other COX-2 specific inhibitor. The new indication for JRA further expand the eligible hands-off population for VIOXX; in tally to the newer indications to too much JRA and migraine pain, VIOXX also is approved for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults, guidance of acute pain in adults and the treatment of earliest dysmenorrhea. Since the front part alert of VIOXX, done 100 million prescription have been documentary in the United States.1 JRA - furthermost established kind of arthritis in home Juvenile rheumatoid arthritis is the most common form of arthritis in children and affect an gruff 30,000 to 50,000 children in the United States.2 It can take sediment in children of any age, but girls be more burgeoning to be pompous than boy. In March, Merck be granted waif pills designation for VIOXX for the treatment of JRA, a designation given to medicine that have been research for the treatment of medical requisites that affect 200,000 those or smaller amount in the United States.

Juvenile rheumatoid arthritis is given to produce unremitting joint inflammation and stiffness that can affect any joint in the thing. There are three spirit group of JRA: pauciarticular, which affects four or a smaller amount joints; polyarticular, which affects five or more joints; and systemic establishment, which affects at lowest sleeping one joint but also cause inflammation of inside organs. The new indication for VIOXX for JRA is with the distinctive utility for patients with pauciarticular or polyarticular JRA.

Approval foot by means of the irritable of largest JRA cram ever conduct The FDA approval of VIOXX for JRA was based on the largest JRA study ever conducted, which integrated 310 pediatric and adolescent patients aged 2 to 17 with moving pauciarticular or polyarticular JRA. Results from the pivotal 12-week multi-national, double-blind study designate once-daily VIOXX confer measurable patch-up in reducing joint symptoms. Improvement was weigh against based on JRA DOI 30 hallmark, a core set of standardized criterion to style guru arthritis impact. A one-year open-label new property to the pivotal study also was conducted to evaluate the long-term sanctuary of VIOXX.

VIOXX was across the world very well abide among pediatric and adolescent patients in the study. The most prevalently report adverse measures in patients taking VIOXX over the 12-week length be upper abdominal pain, nasopharyngitis (viral infectivity of the upper respiratory passages), diarrhea, upper respiratory tract infection, abdominal pain, headache and rhinitis.

VIOXX available in tablet and strawberry-flavored liquid formulation children`s VIOXX offers the convenience and rawness of once-daily dosing in both tablet and strawberry-flavored liquid (oral suspension) formulation. For adolescents 12 to 17 years of age, the recommended dose of VIOXX is 25 mg once on a daily basis. For children and adolescents 2 to 11 years of age, dosing is dependent upon counterweight: for children weigh 22 to 88 pulse, the recommended dose of VIOXX is 0.6 mg/kg to a maximum of 25 mg once daily and for those over 88 pounds, VIOXX 25 mg once daily is recommended. To promote dosing exactitude among babyish children, intake of VIOXX 12.5 mg/5mL oral freeze is recommended.

FDA's looked-for esteem this week of Merck's antiretroviral linctus raltegravir could "break unmarked ground" contained via the dispute in opposition HIV/AIDS, the Wall Street Journal reports. However, notwithstanding the "continuing want and flea market all for HIV healing," by channel of economically as several physicians' "enthusiasm in a circle the drug's prospects," it be "no confident thing" that raltegravir will "pay off" for the guests, according to the Journal (Rubenstein, Wall Street Journal, 10/11).

Commonly reported side effects in clinical trial with VIOXX in adults have included upper-respiratory infection, diarrhea, nausea and glorious blood peril.

VIOXX is approved in the United States for the relief of the signs and symptoms of osteoarthritis and developed rheumatoid arthritis, management of acute pain in adults, primary dysmenorrhea and acute treatment of migraine attack with or without aura in adults. The safety and convenience of VIOXX have not been settled for cluster headache, which is souvenir in an elder, predominantly masculine population.

The recommended starting dose of VIOXX for the treatment of osteoarthritis is 12.5 mg once daily. Some patients may receive added reward by growing the dose to 25 mg once daily.

For rheumatoid arthritis, the recommended dose is 25 mg once daily. The maximum recommended daily dose for osteoarthritis and rheumatoid arthritis is 25 mg once daily.

VIOXX 50 mg once daily is the recommended dose for acute pain and primary dysmenorrhea. Use of VIOXX for greater than five days in management of pain has not been studied. Chronic use of VIOXX 50 mg is nuts.

For the treatment of migraine attacks, the recommended starting dose is 25 mg once daily. Some patients may receive additional benefit with 50 mg as compare to 25 mg. The maximum recommended daily dose is 50 mg. The safety of treating more than five migraine attacks in any given month has not been established. Chronic daily use of VIOXX for the acute treatment of migraine is not recommended.

About Merck Merck & Co., Inc. is a intercontinental research-driven pharmaceutical products people. Merck discover, cultivate, manufacture and market a extensive length of ahead of its time products to improve human and animal vigour, head-on or through its joint jut out over.

Forward-Looking Statement This grasp salvage enclose "forward-looking statements" as that permanent status is defined in the Private Securities Litigation Reform Act of 1995. These statement mess up with risk and uncertainties, which may cause grades to differ materially from those set forth in the statements. The forward-looking statements may contain statements in association with pay advancement, product soon-to-be or economic actions. No forward-looking rule can be guaranteed, and actual results may differ materially from those projected. Merck undertake no requisite to publicly update any forward-looking statement, whether as a ramification of new information, projected events, or otherwise. Forward-looking statements here press release should be evaluated jointly with the oodles uncertainties that affect Merck's company, mainly those mention in the threatening statements in Item 1 of Merck's Form 10-K for the year completed Dec. 31, 2003, and in its intervallic reports on Form 10-Q and Form 8-K (if any), which the company understand by suggestion.

Full prescribe information for VIOXX The full prescribing information is also available by calling 1-800-546-8173 and the patient bundle plant is available by calling 1-800-344-7833.

1 IMS Health, National Prescription Audit (NPA) Plus and NPA Plus 7. Based on unqualified dispense prescriptions for the period May 1999 through April 2004 and the weeks climax May 7 through May 21, 2004.

2 Lawrence, R. et al, "Estimates of the Prevalence of Arthritis and Selected Muculoskeletal Disorders in the United States" Arthritis & Rheumatism Vol. 41, No. 5, 1998:778-799.

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