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Ed. Note: The following
is a press release from the US Food & Drug Administration. Consumer
Inquiries: 888-INFO-FDA
December 23, 2004
The Food and Drug Administration (FDA) today issued a Public Health
Advisory summarizing the agency's recent recommendations concerning the
use of non-steroidal anti-inflammatory drug products (NSAIDs), including
those known as 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
prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib)
and Bextra (valdecoxib) to ensure that adequate precautions are
implemented in the studies and that local Institutional Review Boards
reevaluate them in light of the new evidence that these drugs may increase
the risk of heart attack and stroke. A prevention trial is one in which
healthy people are given medicine to prevent a disease or condition (such
as colon polyps or Alzheimer's disease).
FDA is issuing an advisory because of 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).
Also, as FDA announced earlier this week, 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.
Although the results of these studies are preliminary and conflict with
other data from studies of the same drugs, FDA is making the following
interim recommendations:
- 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 is collecting and will be analyzing all available information from
the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and
other data for COX-2 selective and nonselective NSAID products to
determine whether additional regulatory action is needed. An advisory
committee meeting is planned for February 2005, which will provide for a
full public discussion of these issues.
FDA urges health care providers and patients to report adverse event
information to 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.
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