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FDA Urges Caution Using Cox-2 Inhibitors, Other
Anti-Inflammatory Drugs
New advisory issued as the increase investigation; advice for physicians
and patients issued
Dec. 23, 2004 - The Food and Drug Administration
today issued a Public Health Advisory summarizing the agency's
recent cautions and recommendations concerning the use of non-steroidal
anti-inflammatory drug products (NSAIDs), including those known as COX-2
selective agents. Both are used by millions of senior citizens.
The public health advisory is an interim measure,
pending further review of data that continue to be collected.
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Dec. 21, 2004 - The FDA today released the
following statement containing advice to senior citizens and others on
the halting of the use of Aleve (naproxen) in a clinical trial involving
non-steroidal anti-inflammatory drugs in elderly patients at risk of
developing Alzheimer's Disease.
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Aleve Suspended in Clinical Trial Due to Increased
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Dec. 21, 2004 The use of Aleve and Celebrex was
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FDA Confirms They Asked Pfizer to Stop Celebrex
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Dec.
21, 2004 The Food and Drug Administration has confirmed that on
December 17 the agency asked Pfizer, Inc. to voluntarily suspend
advertising on Celebrex during the time the FDA is obtaining and
evaluating the new and conflicting scientific data on adverse events
associated with the drug. Pfizer agreed with the request.
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FDA Delays Action on Celebrex, Waiting for More
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Dec.
18, 2004 Late yesterday the Food and Drug Administration issued a
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pain relief, primarily that caused by arthritis. The FDA says they are
taking no regulatory action now but will seek more information.
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NIH Halts Use of COX-2 Inhibitor
in Large Cancer Prevention Trial
Dec.
18, 2004 -
The National Institutes of Health (NIH) announced
Friday that it has suspended the use of COX-2 inhibitor celecoxib
(Celebrex Pfizer, Inc.) for all participants in a large colorectal
cancer prevention clinical trial conducted by the National Cancer
Institute (NCI). More...
12/18/04*
Celebrex Caused Increase Heart Problem Risk:
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Dec.
17, 2004 Celebrex has been found to cause increased risk of heart
problems, according to an announcement by Pfizer, maker of the
painkiller. Often used by senior citizens
with arthritis, Celebrex is in the same class as the Vioxx, the drug
yanked off the market in September because of similar concerns.
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Pfizer Claims Celebrex Safety in September:
Day Vioxx Recalled
Dec. 17, 2004 On September 30, the day Merck &
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release expressing confidence that Celebrex did not cause heart
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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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