Analgesia and Anti-inflammatory 
Drug Information

This web site provides information on the approval process and approved therapies for analgesia and anti-inflammatory related drugs. The Division of Anesthesia, Analgesia, and Rheumatology Products (DAARP) reviews these drugs.

Analgesics are drugs that relieve pain.

Anti-inflammatories are drugs used to reduce inflammation - the redness, heat, swelling, and increased blood flow found in infections and in many chronic non-infective diseases such as rheumatoid arthritis and gout.

FDA safety information on COX-2 selective non-steroidal anti-inflammatory drugs  (NSAIDs), including Bextra, Celebrex, Naproxen, and Vioxx are available at this web site: http://www.fda.gov/cder/drug/infopage/COX2/default.htm 

Biologic drugs are derived from living sources (such as humans, animals, and microorganisms) in contrast to conventional small molecule drugs that are chemically synthesized. Several biologics are approved for treatment of rheumatoid arthritis, including the TNF-alpha blockers Enbrel, Remicade and Humira and the IL-1 blocker Kineret. Some of the biologics are also approved for other forms of arthritis, including psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile rheumatoid arthritis.

• Regulatory Issues from DAAODP
  • An Advisory Committee meeting is planned for February 16, 17, and 18, 2005.
    • On February 16, 2005, the committee will hear a safety update on the cardiovascular risks associated with the use of VIOXX and discuss the relative benefits and risks associated with the use of this drug.
    • On February 17, 2005, the committee will hear a safety update on the cardiovascular risks associated with BEXTRA and CELEBREX, as well as similar drugs currently in development. The discussion will include the benefits and risks of the COX-2 Inhibitor class of drugs and recommendations for managing cardiovascular risk for the entire class.
    • On February 18, 2005, the committee will continue discussions regarding benefits and risks of the COX-2 Inhibitors.
       
• Analgesia and Anti-inflammatory Drug Development Guidance  contains links to specific FDA Analgesia & Anti-inflammatory guidance and Advisory Committee information 
• Approved Analgesic and Anti-inflammatory Drugs
• FDA issues a Public Health Advisory on Vioxx as its manufacturer voluntarily recalls the product. (9/30/2004) Vioxx Information.
• Arthritis Web Resources
• 2004 Arthritis Advisory Committee Meeting on Gout, June 2 and 3, 2004, from 8 a.m. to 5 p.m.  (Posted 4/29/2004)
• 2003 Meetings of the Arthritis Advisory Committee,
  • Meeting topics:
    • 3/4/2003-3/5/2003, rheumatoid arthritis drugs
    • 6/23/2003, Fibrolmyalgia
    • 6/24/2003, Enbrel (etanercept) for ankylosing spondylitis
    • 9/29/2003-9/30/2003, systemic lupus erythematosis (SLE)
• Items of Interest
  • Draft Guidance for Industry: Pharmacogenomic Data Submissions [Word] or [PDF] (Issued 11/2003)