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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)
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FDA/Center for Drug Evaluation and Research
Last Updated: December 14, 2005
Originator: OTCOM/DLIS
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