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Vioxx FDA Alerts

The FDA Alerts below may be specifically about Vioxx or relate to a group or class of drugs which include Vioxx.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Vioxx

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

[April 07, 2005 - Public Health Advisory - FDA]
[April 07, 2005 - Drug Information Page - FDA]
[April 07, 2005 - Questions and Answers - FDA]


Vioxx (rofecoxib) - Jun 15, 2005

FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA 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 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. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.

[June 15, 2005 - Drug Information Page - FDA]
[June 15, 2005 - Medication Guide - FDA-Approved] PDF Format


Vioxx (rofecoxib) - Apr 7, 2005

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

[April 07, 2005 - Public Health Advisory - FDA]
[April 07, 2005 - Drug Information Page - FDA]
[April 07, 2005 - Questions and Answers - FDA]


Vioxx (rofecoxib) - Sep 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, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. 

[September 30, 2004 Public Health Advisory - FDA]
[September 30, 2004 Press Release - FDA]
[September 30, 2004 Questions and Answers (Q&As) - FDA]


Vioxx (rofecoxib) - May 6, 2002

FDA and Merck strengthened the WARNINGS, PRECAUTIONS, and CLINICAL STUDIES sections of Vioxx labeling to describe new cardiovascular and gastroenterological safety information. This information reflected the results of a prospective, active control study of Vioxx 50 mg daily versus naproxen 500 mg twice daily and from a placebo-controlled trials database. This information should be taken into consideration and caution should be exercised when Vioxx is used in patients with a medical history of ischemic heart disease.

[April 11, 2002 Talk Paper - FDA]
[April, 2002 Letter - Merck] 48 KB PDF file
[April, 2002 Full, revised, highlighted label - Merck] 2.4 MB PDF file
[April, 2002 Patient Package Insert, highlighted - Merck] 31 KB PDF file

More Vioxx Resources