In early 2005, the Food and Drug Administration (FDA) announced important changes for all non-steroidal anti-inflammatory (NSAID) medicines, including CELEBREX and other prescription and non-prescription NSAIDs. The FDA requested that the safety information of all of these products include information about cardiovascular and gastrointestinal risks. Therefore, the FDA is requesting manufacturers of all prescription NSAIDs to include boxed warnings identifying these risks.
Physicians have to weigh up the known risks of taking Celebrex against the risks of using alternatives such as ibuprofen, which itself can cause major health problems, with gastro-intestinal bleeding being a not uncommon problem.
Celebrex was launched in January
1999 as a pain relief drug for arthritis. Over 3.2 million Celebrex
scripts were issued in the first 15 weeks, overtaking the previous
Viagra record (3.1 million). But does Celebrex work?
How does Celebrex work? What are Celebrex side
effects?
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Celebrex
appears to have small but steady lead over Vioxx with 51%
to 49% of scripts in the early part of 2000. - see e-mail
for more data and investment discussions.
Celebrex may
prevent colon cancer - 77 people with familial adenomatous
polyposis were given Celebrex. After 6 months the
number of polyps in those taking 400mg Celebrex a day were
reduced by 28%. There was a 12% reduction on
100mg Celebrex a day. New England Journal of Medicine
28 June 2000
New drugs like
Celebrex contribute to 17.4% increase in US spending on
prescription drugs. Wall Street Journal 27 June 2000
Celebrex causes
less oedema and blood pressure problems than Vioxx - according
to a six-week, multi-centre, randomised, double-blind, parallel
study of both drugs in 800 people with high blood pressure
and osteoarthritis. Royal Society of Chemistry 22
June 200
Long-term safety
study shows 25% fewer physician consultations for arthritis
patients taking celebrex compared with non-steroidal anti-inflammatory
drugs such as Brufen. Canada Newswire 22 June 2000
Vioxx gives
slightly better pain relief and comfort at night than Celebrex.
Dow Jones report 22 June 2000
Australia government
subsidizes Celebrex sales by $217m to encourage use. The
average user will save $40 on Celebrex every month.
An estimated 500,000 Australians will benefit. Daily Telegraph
Australia 6 June 2000
Monsanto has
made Celebrex TV commercials without naming Celebrex to
avoid Federal laws requiring side-effects to be stated on
adverts. This follows reports of stomach ulcers and
deaths in a small minority treated with Celebrex.
Existing drugs of a similar kind produce potentially fatal
bleeding ulcers in around 1% of those treated long term.
Expert consensus is that Celebrex appears to have a far
lower risk of bleeding ulcers than any conventional non-steroidal
anti-inflammatory drugs, and should therefore be taken with
confidence by those with osteo-arthritis or rheumatoid arthritis,
under medical supervision. Wall Street Journal: 4 May 1999
Celebrex is
the first of Cox-2 inhibitors - traditional anti-inflammatory
drugs target general prostaglandin production, affecting
both Cox-1 and Cox-2 enzymes. Cox-1 inhibition can
lead to ulcers. Cox-2 inhibitors are said to cause
far less gastro-intestinal problems. A second Cox-2
inhibitor, Vioxx made
by Mercck and Co has now been released and has overtaken
even Celebrex in speed of sales. Celebrex name is
causing confusion with other similar sounding drugs. Advertising
Age: 3 May 1999
Over 350,000
scripts a week of Celebrex. Business Wire: 23 April
1999
Press statement after reports of 10 Celebrex
deaths and sharp fall in script issues: "GD Searle's
(Monsanto is subsidiary - ed) first interest is always patient
safety. We take all adverse reaction reports seriously,
review them appropriately, and share information with the
FDA. GD Searle's medical review of the individual 10 reports
to the FDA indicates no direct causality between Celebrex
usage and any of the reported deaths. Celebrex is already
being used by more than 2 M people. There is nothing in
the post-marketing reports to alter our confidence in the
safety and effectiveness of Celebrex. Our experience shows
that the drug is safe and effective when used as prescribed
within the label." Federal Drugs Agency says
no need to worry about Celebrex "super-aspirin"
Chemical Business Newsbase 21 April 1999
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