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  1. Postmarket Drug Safety Information for Patients and Providers

COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

For past information on non-steroidal anti-inflammatory drugs (NSAID), please see the FDA Archive

[4/7/2005] 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;

  • review of the regulatory histories and new drug application (NDA) databases of the various NSAIDs,
  • FDA and sponsor background documents prepared for the joint Advisory Committee meeting of FDA's Arthritis and Drug Safety and Risk Management Advisory Committees, held February 16-18, 2005,
  • all materials and data submitted by other stakeholders to the Advisory Committee meeting,
    presentations made at the joint meeting
  • the specific votes and recommendations made by the joint Committee.

Further information regarding the decisions being announced and specific details regarding the individual products can be found within the documents posted on this Web page.

 COX-2 Selective Drugs

 Bextra (valdecoxib)

On April 7, 2005, the Food and Drug Administration (FDA) asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market.

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 Celebrex (celecoxib)

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)

[9/30/2004] 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.

Background Information

Other Prescription Non-selective NSAIDs

 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
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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