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Public Health Advisory
Non-Steroidal Anti-Inflammatory
Drug Products (NSAIDS)
The FDA is issuing a public health advisory concerning use of
non-steroidal anti-inflammatory drug products (NSAIDS) including
those known as COX-2 selective agents.
Recently released data from controlled clinical trials showing
that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be
associated with an increased risk of serious cardiovascular events
(heart attack and stroke) especially when they are used for long
periods of time or in very high risk settings (immediately after
heart surgery).
Preliminary results from a long-term clinical trial (up to three
years) suggest that long term use of a non-selective NSAID, naproxen
(sold as Aleve, Naprosyn and other trade name and generic products),
may be associated with an increased cardiovascular (CV) risk
compared to placebo.
While the results of these studies are preliminary and conflict
with other study data on the same drugs, FDA is providing this
advisory as an interim measure, pending further review of data that
continue to be collected. Specifically:
- Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib),
should consider this emerging information when weighing the
benefits against risks for individual patients. Patients who are
at a high risk of gastrointestinal (GI) bleeding, have a history
of intolerance to non-selective NSAIDs, or are not doing well on
non-selective NSAIDs may be appropriate candidates for COX-2
selective agents.
- Individual patient risk for cardiovascular events and other
risks commonly associated with NSAIDs should be taken into account
for each prescribing situation.
- 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 should be consulted.
Non-selective NSAIDs are widely used in both over-the-counter
(OTC) and prescription settings. As prescription drugs, many are
approved for short-term use in the treatment of pain and primary
dysmenorrhea (menstrual discomfort), and for longer-term use to
treat the signs and symptoms of osteoarthritis and rheumatoid
arthritis. FDA has previously posted extensive NSAID medication
information at
http://www.fda.gov/cder/drug/analgesics/default.htm.
FDA will be analyzing all available information from the new
studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for
non-selective NSAIDs and COX-2 selective products to determine
whether additional regulatory action is needed. An advisory
committee meeting is planned for February 2005 which will provide
for a full discussion of these issues.
FDA Talk Paper
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Date created: December 23, 2004 |
