We've noticed that you're using an ad blocker

Our content is brought to you free of charge because of the support of our advertisers. To continue enjoying our content, please turn off your ad blocker.

It's off now Dismiss How do I disable my ad blocker?
❌

How to disable your ad blocker for our site:

Adblock / Adblock Plus
  • Click on the AdBlock / AdBlock Plus icon on the top right of your browser.
  • Click “Don’t run on pages on this domain.” OR “Enabled on this site.”
  • Close this help box and click "It's off now".
Firefox Tracking Prevention
  • If you are Private Browsing in Firefox, "Tracking Protection" may casue the adblock notice to show. It can be temporarily disabled by clicking the "shield" icon in the address bar.
  • Close this help box and click "It's off now".
Ghostery
  • Click the Ghostery icon on your browser.
  • In Ghostery versions < 6.0 click “Whitelist site.” in version 6.0 click “Trust site.”
  • Close this help box and click "It's off now".
uBlock / uBlock Origin
  • Click the uBlock / uBlock Origin icon on your browser.
  • Click the “power” button in the menu that appears to whitelist the current website
  • Close this help box and click "It's off now".
  • Topics
  • Dermatology
  • Cardiovascular
  • Diabetes
  • GI
  • HIV/AIDS
  • Quiz
  • Photoclinic
  • Image IQ
  • Special Report

Modern Medicine Network
  • Login
  • Register
Skip to main content
Modern Medicine Network
  • Login
  • Register
Menu
User
Home
  • Topics
  • Dermatology
  • Cardiovascular
  • Diabetes
  • GI
  • HIV/AIDS
  • Quiz
  • Photoclinic
  • Image IQ
  • Special Report

SUBSCRIBE: eNewsletter

Celebrex Approved for Juvenile Rheumatoid Arthritis

  • Mark Bloom
Dec 15, 2006
  • Musculoskeletal Disorders, Infection, Rheumatoid Arthritis

ROCKVILLE, Md., Dec. 15 -- Acting with uncommon speed, the FDA today approved Celebrex (celecoxib) for the pain of juvenile rheumatoid arthritis -- less than a month after an advisory committee recommended overwhelmingly that it do so.

The panel had voted 15 to one that the benefits of the Cox-2 inhibitor outweighed its risks in rheumatoid arthritis patients ages two and older.

In the approval, the agency noted that Celebrex has not been studied in patients under the age of two years, in patients who weigh less than 22 pounds, or in patients showing signs of having systemic-onset JRA -- a more serious type of the disease associated with high fever and rash.

The FDA said Celebrex should be used only with caution in patients with systemic-onset JRA due to the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with disseminated intravascular coagulation.

"Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer term cardiovascular problems," said the FDA.

The agency said Pfizer, the maker of Celebrex, agreed to conduct two phase IV post-marketing studies -- a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.

"JRA is often a devastating disease," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "While there are other medicines approved for the treatment of this disorder, for some children they may have limited effectiveness or cause intolerable side effects. Celebrex will be a needed additional treatment option for children."

Pages

  • 1
  • 2
  • next ›
  • last »

Related Articles

  • Mastering Rheumatoid Arthritis: 5 Key Challenges for Primary Care Practice
  • NSAIDs for Chronic Low Back Pain: True or False?
  • RA and Primary Care: 8 Looks to the Future
  • 7 New Hip Osteoarthritis Recommendations
  • RA Comanagement and the Future

Resource Topics rightRail

  • Resource Topics
  • Partner Content
Asthma
Atrial Fibrillation
Respiratory Diseases
Headache and Migraine
Hepatitis C
There is currently no available content. Please check back soon.
Connect with Us
  • Twitter
  • Facebook
  • LinkedIn
  • RSS
Modern Medicine Network
  • Home
  • About Us
  • Advertise
  • Advertiser Terms
  • Privacy statement
  • Terms & Conditions
  • Editorial & Advertising Policy
  • Editorial Board
  • Contact Us
Modern Medicine Network
© UBM 2018, All rights reserved.
Reproduction in whole or in part is prohibited.