FDA Talk Paper


December 23, 2004

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FDA Issues Public Health Advisory

Recommending Limited Use of Cox-2 Inhibitors

Agency Requires Evaluation ofPrevention Studies Involving Cox-2 Selective Agents

The Food and Drug Administration (FDA) today issued a Public Health Advisorysummarizing the agency's recent recommendations concerning the use ofnon-steroidal anti-inflammatory drug products (NSAIDs), including those knownas COX-2 selective agents. The public health advisory is an interim measure,pending further review of data that continue to be collected.

In addition, FDA today announced that it is requiring evaluation of all preventionstudies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra(valdecoxib) to ensure that adequate precautions are implemented in the studiesand that local Institutional Review Boards reevaluate them in light of the newevidence that these drugs may increase the risk of heart attack and stroke. Aprevention trial is one in which healthy people are given medicine to preventa disease or condition (such as colon polyps or Alzheimer's disease).

FDA is issuing an advisory because of recently released data from controlledclinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, andBextra) may be associated with an increased risk of serious cardiovascular events(heart attack and stroke) especially when they are used for long periods of timeor in very high risk settings (immediately after heart surgery).
Also, as FDA announced earlier this week, preliminary results from a long-termclinical trial (up to three years) suggest that long-term use of a non-selectiveNSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products),may be associated with an increased cardiovascular (CV) risk compared to placebo.

Although the results of these studies are preliminary and conflict with otherdata from studies of the same drugs, FDA is making the following interim recommendations:
Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), shouldconsider this emerging information when weighing the benefits against risksfor individual patients. Patients who are at a high risk of gastrointestinal(GI) bleeding, have a history of intolerance to non-selective NSAIDs, or arenot doing well on non-selective NSAIDs may be appropriate candidates for Cox-2selective agents.

Individual patient risk for cardiovascular events and other riskscommonly associated with NSAIDs should be taken into account for each prescribingsituation.
Consumers are advised that all over-the-counter (OTC) pain medications,including NSAIDs, should be used in strict accordance with the label directions.If use of an (OTC) NSAID is needed for longer than ten days, a physician shouldbe consulted.

Non-selective NSAIDs are widely used in both over-the-counter (OTC) andprescription settings. As prescription drugs, many are approved for short-termuse in the treatment of pain and primary dysmenorrhea (menstrual discomfort),and for longer-term use to treat the signs and symptoms of osteoarthritisand rheumatoid arthritis. FDA has previously posted extensive NSAID medicationinformation at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA is collecting and will be analyzing all available information fromthe most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and otherdata for COX-2 selective and nonselective NSAID products to determine whetheradditional regulatory action is needed. An advisory committee meeting isplanned for February 2005, which will provide for a full public discussionof these issues.

FDA urges health care providers and patients to report adverse event informationto FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178),or by the Internet at http://www.fda.gov/medwatch/index.html.

The Public Health Advisory is available online at www.fda.gov/cder/drug/advisory/nsaids.htm.

source: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html

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