US regulator calls for limits on use of Celebrex, Bextra

Thu Dec 23, 5:58 PM ET

WASHINGTON (AFP) - US regulators called for use of Pfizer's painkilling
drugs Celebrex and
Bextra to be limited, urging doctors to keep in mind indications of
higher heart attack and stroke risks.

                   The Food and Drug Administration (news - web sites)
issued a press
                   release saying it was "recommending limited use of
Cox-2 inhibitors."
                   Cox-2 inhibitors are the latest type of non-steroid
painkiller.

                   The only "Cox-2 inhibitors" still on the market are
Celebrex and Bextra,
                   both made by Pfizer. Vioxx, made by Merck and Co.,
was withdrawn in
                   September because of increased risk of heart
attacks.

                   But all three -- 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)," the FDA
(news - web sites)
                   said.

                   "Physicians prescribing Celebrex (celecoxib) or
Bextra (valdecoxib), should
                   consider this emerging information when weighing the
benefits against risks
                   for individual patients," the FDA said in a public
health advisory.

                   The FDA advisory listed only a limited selection of
patients who may be
                   appropriate candidates to use Cox-2, rather than the
more traditional,
"non-selective" non-steroidal anti-inflammatory drugs.

"Patients who are at a high risk of gastrointestinal 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," the FDA said.

A National Cancer Institute (news - web sites) study into the use of
Celebrex to prevent benign
tumours, or adenomas, was suspended after finding a heart attack risk.

It found patients taking 400 milligrams of Celebrex twice daily had a
3.4 times greater risk of
"cardiovascular events" compared to placebo and patients taking 200
milligrams of Celebrex twice
daily had a 2.5 times greater risk, according to the FDA.

The FDA said it was now ordering a re-evaluation of all similar
"prevention trials" into Celebrex or
Bextra. Prevention trials test whether use of the drugs in healthy
patients may prevent other conditions
such as cancer.

Regulators said they wanted to "ensure that adequate precautions are
implemented in the studies and
that local institutional review boards re-evaluate them in light of the
new evidence that these drugs may
increase the risk of heart attack and stroke."

Preliminary results from a long-term clinical trial also showed that a
widely used "non-selective"
painkiller -- naproxen, sold as Aleve, Naprosyn and other names -- may
be associated with heart
attack and stroke risks, the FDA said.

"Consumers are advised that all over-the-counter pain medications,
including NSAIDs, should be used
in strict accordance with the label directions. If use of an
(over-the-counter) NSAID is needed for longer
than 10 days, a physician should be consulted."

Pfizer said Monday it will stop advertising painkiller Celebrex after a
trial indicated a heart-attack risk
at high doses, but vowed to carry on sales, saying it remained an
important medicine for many people.

The more traditional "non-selective" painkillers carry other risks, it
said, such as gastrointestinal
bleeding.

While the research released last week linked high doses of Celebrex to
heart problems in some
patients, other studies found no adverse effects, the company said.

Meanwhile, a Canadian law firm has launched a 1.5 billion dollar (1.2
billion US) class action lawsuit
against US pharmaceutical company Pfizer, on behalf of a woman who
claims she had heart problems
after taking Celebrex.

The complaint was filed by law firm McPhadden Samac Merner Darling
against Pfizer Canada et Pfizer
Inc., said Bryan McPhadden, one of the firm's attorneys.

The suit accused Pfizer of negligence and claims the lead complainant, a
woman from Mississauga,
near Toronto, suffered loss of earnings because of health problems
allegedly associated with the
anti-inflammatory drug.