Patients
taking a class of painkilling drugs called Cox-2 inhibitors
have been advised to contact their GP to review their treatment.
The
advice follows a study suggesting one of the drugs, Celebrex,
increased the risk of heart problems.
--
Celebrex is used to treat arthritis --
The
Medicines and Healthcare products Regulatory Agency advice
applies to people taking Celebrex, Bextra and Arcoxia.
The agency stressed their was no need to make an urgent appointment.
"Patients
taking any of these drugs should contact their doctor at the
next convenient appointment to discuss their treatment."
--- Professor Gordon Duff
Patients
who have established heart disease or who are at high risk
of stroke will have their treatment changed.
For all other patients, alternative treatments will be considered
on the basis of their medical history.
Celebrex, manufactured by Pfizer, and other drugs of the same
type are used in the treatment of pain and inflammation in
osteoarthritis and rheumatoid arthritis, and in the management
of acute pain.
Widely used
Celebrex is used by an estimated 600,000 patients in the UK.
The new advice follows a study by the US Cancer Institute
which found patients were at an increased risk of heart attack
and stroke after taking Celebrex.
The study, of 2,400 patients, found that patients who took
a dose of 400mg of Celebrex a day were 2.5 times more likely
to have a heart attack or stroke than people taking a placebo.
Those taking a 800mg daily dose were at 3.4 times the risk.
An alternative Cox-2 inhibitor, Vioxx, was withdrawn by its
makers Merck in September following similar concerns.
In that long-term study taking Vioxx for 18 months or more
was linked to an increased risk of heart attack and stroke.
Professor Gordon Duff, chairman of the Committee on the Safety
of Medicines, said: "Patients taking any of these drugs should
contact their doctor at the next convenient appointment to
discuss their treatment.
"The Committee on the Safety of Medicines is waiting for the
study data. Once this is available, the committee will carefully
consider this and issue further advice."
Cox-2 inhibitors are marketed as a safer alternative to the
more traditional non-steroidal anti-inflammatory drugs (NSAIDs)
which are associated with side effects.
The European Medicines Evaluation Agency is currently assessing
their use.
Pfizer issued a statement in which it said it was working
carefully to evaluate the information and liaising with the
regulatory authorities to fully understand it's implications
for patients.
Chief executive officer Hank McKinnell said on Monday that
the company had no plans to withdraw Celebrex.
Instead, he predicted that the US regulatory authority, the
Food and Drug Administration, would adjust the labelling of
the product.
Mr McKinnell said: "We fully expect that Celebrex will be
found safe and effective when taken as directed."
GPs' reaction
Dr Jim Kennedy, of the Royal College of GPs, said: "We do
not know the full results of this (Celebrex) study and do
not want to see patients unduly worried.
"If patients are concerned, we would advise them to stop taking
these medicines and use another pain-killer, which their local
pharmacist will be able to advise them on.
"In addition, we also advise patients, particularly those
with established heart disease or who are at high risk of
stroke, to follow the MHRA advice and make a routine appointment
with their GP to discuss a possible alternative prescription.
"Patients should be reassured that there are several other
treatments available for arthritic pain relief. We look forward
to seeing the results of this study as soon as possible."
Patients
taking a class of painkilling drugs called Cox-2 inhibitors
have been advised to contact their GP to review their treatment.
