[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.
- Decision Memo - Analysis and Recommendations for Agency Action - COX-2 Selective and Non-selective NSAIDs (PDF - 143KB) (issued 4/6/2005, posted 4/15/2005)
- COX-2 Selective Drugs (including Bextra, Celebrex, and Vioxx)
- Prescription NSAID Products (6/15/2005)
- Over-the-Counter NSAID Products
- New July 15, 2005. The agency has issued new supplemental labeling request letters for OTC NSAID products. The Agency received comments from industry regarding the June 14th supplemental labeling request letter and labeling template. Upon completion of our review of the comments, the Agency has decided to make revisions to the OTC labeling template and issue a new supplemental labeling request letter.
- Table of Drug Products - 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)
On April 7, 2005, the Food and Drug Administration (FDA) asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market.
[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.
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|
|Chemical Name||Brand Name|
|Diclofenac||Cataflam, Voltaren, Arthrotec (combination with misoprostol)|
|Etodolac||Lodine, Lodine XL|
|Fenoprofen||Nalfon, Nalfon 200|
|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|
|Naproxen**||Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)|
|Tolmetin||Tolectin, Tolectin DS, Tolectin 600|