Celebrex FDA Warning – Celebrex Lawyer Referral Service

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,

· all materials and data submitted by other stakeholders to the Advisory Committee meeting,
presentations made at the joint meeting

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.

o New Over-the-Counter (OTC) Nonsteriodal Anti-Inflammatory Drug (NSAID) Products.

§ 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.

· 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) Table of Drug Products

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

FDA Talk Paper (12/9/2004)

· Questions and Answers: Strengthening Warnings on Bextra (12/9/2004)

Consumer Information Sheet

· FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors. FDA Talk Paper (12/23/2004)

· Public Health Advisory: Non-Steroidal Anti-Inflammatory Drug Products (NSAIDs) (12/23/2004)

Celebrex (celecoxib)

Current Information

· Patient Information Sheet [ PDF ] or [ HTML ]

· Healthcare Professional Information

o Healthcare Professional Sheet [ PDF ] or [ HTML ]

o Prescribing Information (Celebrex Label)

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.

· Regulatory History of Celebrex from Drugs@FDA

· FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex (12/17/2004)

· FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors. FDA Talk Paper (12/23/2004)

· Public Health Advisory: Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS) (12/23/2004)

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)

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)

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