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FDA Delays Action on Celebrex, Waiting for More Info
Dec.
18, 2004 Late yesterday the Food and Drug Administration issued a
statement on the warning issued by Pfizer of possible heart problems
caused by their drug Celebrex, which is taken my millions of senior
citizens for 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
Celebrex Caused Increase Heart Problem Risk:
Pfizer
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.
More... 12/17/04*
Pfizer Claims Celebrex Safety in September:
Day Vioxx Recalled
Dec. 17, 2004 On September 30, the day Merck &
Co. announced the recall of its COX-2 drug, Vioxx, Pfizer issued a news
release expressing confidence that Celebrex did not cause heart
problems, as found in the case of Vioxx.
More... 12/17/04*
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Following is the FDA statement on the halting of a
clinical trial of the Cox-2 inhibitor Celebrex (celecoxib):
The Food and Drug Administration (FDA)
learned last night from the National Cancer Institute (NCI) and Pfizer,
Inc., that NCI has stopped drug administration in an ongoing clinical
trial investigating a new use of Celebrex (celecoxib) to prevent colon
polyps because of an increased risk of cardiovascular (CV) events in
patients taking Celebrex versus those taking a placebo.
Patients in the clinical trial taking 400
mg. of Celebrex twice daily had a 3.4 times greater risk of CV events
compared to placebo. For patients in the trial taking 200 mg. of
Celebrex twice daily, the risk was 2.5 times greater. The average
duration of treatment in the trial was 33 months.
A similar ongoing study comparing Celebrex
400 mg. once a day versus placebo, in patients followed for a similar
period of time, has not shown increased risk.
Although these are important findings, at
this point FDA has seen only the preliminary results of the studies. FDA
will obtain all available data on these and other ongoing Celebrex
trials as soon as possible and will determine the appropriate regulatory
action.
While we have not seen all available data
on Celebrex, these findings are similar to recent results from a study
of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx
was recently voluntarily withdrawn by Merck. Another drug in this class,
Bextra (valdecoxib) has shown an increased risk for CV events in
patients after heart surgery. Bextra and Celebrex are the only two
selective COX-2 agents currently on the U.S. market.
Physicians should consider this evolving
information in evaluating the risks and benefits of Celebrex in
individual patients. FDA advises evaluating alternative therapy. At this
time, if physicians determine that continued use is appropriate for
individual patients, FDA advises the use of the lowest effective dose of
Celebrex.
Patients who are currently taking Celebrex
and have questions or concerns about the drug should discuss them with
their physicians.
Celebrex was approved in 1998 for the
treatment of osteoarthritis and rheumatoid arthritis. Previous large
studies of Celebrex, including clinical trials and epidemiology studies,
have not suggested the sort of CV risk found in the NCI polyp study.
Because similar long-term studies of other products in the class of
non-steroidal anti-inflammatory drugs (NSAIDS), other than Cox-2
inhibitors have not been done, it is not known whether other NSAIDS pose
a similar risk.
FDA will provide updates on Celebrex in
particular and this class of drugs in general as more information
becomes available.
End of FDA Statement
