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COX-2
Selective (includes Bextra, Celebrex, and Vioxx) and
Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) has issued
supplemental request letters to sponsors of all non-steroidal
anti-inflammatory drugs (NSAID) requesting that they make labeling
changes to their products. These letters include recommended
proposed labeling for both the prescription and over-the-counter
(OTC) NSAIDs and a medication guide for the entire class of
prescription products. All sponsors of marketed prescription
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib),
a COX-2 selective NSAID, have been asked to revise the labeling
(package insert) for their products to include a boxed warning,
highlighting the potential for increased risk of cardiovascular (CV)
events and the well described, serious, potential life-threatening
gastrointestinal (GI) bleeding associated with their use. The
Celebrex labeling will, in addition to the general labeling that
will apply to all NSAIDs, also contain safety data from long-term
treatment trials with celecoxib.
Manufacturers of non-prescription (over-the-counter) NSAIDs
are being asked to revise their labeling to provide more specific
information about the potential CV and GI risks of their individual
products and remind patients of the limited dose and duration of
treatment of these products in accordance with the package
instructions
In making these decisions, the Center for Drug Evaluation and
Research (CDER) considered the risk/benefit profile for each of the
drugs. Also considered was;
Further information regarding the
decisions being announced and specific details regarding the
individual products can be found within the documents posted to this
Web page.
COX-2 Selective Drugs
Bextra (valdecoxib)
Current Information
On April 7, 2005, the Food and Drug Administration
(FDA) asked Pfizer to voluntarily remove Bextra (valdecoxib)
from the market.
- Healthcare Professional Sheet [PDF]
[HTML]
Background Information
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Celebrex (celecoxib)
Current Information
- Patient Information Sheet
[PDF] or [HTML]
- Healthcare Professional
Information
Background Information
FDA Alert:
3/2005.
Based on emerging information, including preliminary reports
from one of several long term National Institutes of
Health (NIH) prevention studies, the
risk of cardiovascular events (composite endpoint including
MI, CVA and death) may be increased
in patients receiving Celebrex. FDA will be analyzing all
available information from these
studies to determine whether additional regulatory action is
needed.
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Vioxx (rofecoxib)
Background Information
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib)
from the U.S. and worldwide market due to safety concerns of an
increased risk of cardiovascular events (including heart attack and
stroke) in patients on Vioxx. Vioxx is a prescription COX-2
selective, non-steroidal anti-inflammatory drug (NSAID) that was
approved by FDA in May 1999 for the relief of the signs and symptoms
of osteoarthritis, for the management of acute pain in adults, and
for the treatment of menstrual symptoms. Vioxx was later approved for
the relief of the signs and symptoms of rheumatoid arthritis in
adults and children.
- Statement by Dr. Steven Galson, Acting Director, Center for
Drug Evaluation and Research (CDER), Regarding November 18, 2004,
Committee on Finance of the U.S. Senate Hearing on Drug Safety and
the Worldwide Withdrawal by Merck & Co., Inc., of Vioxx.
FDA Statement (11/18/2004)
-
Congressional Statement on Vioxx and Drug Safety (Posted
11/18/2004)
- FDA releases a statement on Vioxx and recent allegations, and
on the Agency's continued commitment to sound science and peer
review.
FDA Statement (Posted
11/17/2004)
- Slide Presentation by Sandra Kweder, M.D., November 10, 2004.
[HTML] [PowerPoint] (Posted
11/10/2004)
- FDA Acts to Strengthen the Safety Program for Marketed Drugs.
FDA Statement (11/5/2004)
- 9/30/2004 Study Report
(Posted
11/2/2004)
- FDA Issues Public Health Advisory on Vioxx as its Manufacturer
Voluntarily Withdraws the Product.
FDA News (9/30/2004)
- FDA Public Health Advisory: Safety of
Vioxx
(9/30/2004)
- Vioxx (rofecoxib) Questions and Answers
(9/30/2004)
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Other Prescription Non-selective NSAIDs
Current Information
- Patient Information Sheet (coming soon)
- Healthcare Professional Information [PDF]
[HTML]
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COX-2 Selective Non-steroidal
Anti-inflammatory Drugs (NSAIDs) and Prescription and Over-the-Counter (OTC) Non-selective NSAIDs
Approved Under New Drug Application (NDA) Abbreviated New Drug Application (ANDA)
COX-2 Selective NSAIDs |
Chemical Name |
Brand Name |
Celecoxib |
Celebrex |
Valdecoxib |
Bextra |
Rofecoxib |
Vioxx |
Non-selective NSAIDs |
Chemical Name |
Brand Name |
Diclofenac |
Cataflam, Voltaren, Arthrotec (combination with
misoprostol) |
Diflunisal |
Dolobid |
Etodolac |
Lodine, Lodine XL |
Fenoprofen |
Nalfon, Nalfon 200 |
Flurbiprofen |
Ansaid |
Ibuprofen** |
Motrin, Motrin IB, Motrin Migraine Pain, Advil,
Advil Migraine Liqui-gels, Ibu-Tab 200, Medipren, Cap-Profen,
Tab-Profen, Profen, Ibuprohm, Children's Elixsure
*, Vicoprofen (combination with
hydrocodone), Combunox (combination with oxycodone) |
Indomethacin |
Indocin, Indocin SR, Indo-Lemmon, Indomethegan |
Ketoprofen** |
Oruvail, Orudis, Actron |
Ketorolac |
Toradol |
Mefenamic Acid |
Ponstel |
Meloxicam |
Mobic |
Nabumetone |
Relafen |
Naproxen** |
Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn,
Naprelan, Naprapac (copackaged with lansoprazole) |
Oxaprozin |
Daypro |
Piroxicam |
Feldene |
Salsalate |
Disalcid |
Sulindac |
Clinoril |
Tolmetin |
Tolectin, Tolectin DS, Tolectin 600 |
*There are many
OTC Combinations with ibuprofen: Advil Cold And Sinus, Advil
Cold, Advil Allergy Sinus, Children's Advil Allergy Sinus,
Ibuprohm Cold and Sinus, Sine-Aid IB, Children's Motrin Cold.
**There are over-the-counter versions of these prescription medications. |
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Date created: April 7, 2005, updated July 18, 2005 |
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