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Arthritis drug heart harm claim
Source:
BBC News
An arthritis drug removed over safety concerns last
year could have been linked to thousands of heart
problems, and even deaths, researchers estimate.
The Food and Drug Administration study in the Lancet
said Vioxx could have caused up to 140,000 cases of
coronary heart disease in the US since 1999.
But makers Merck said there were many risk factors and
the data did not show the drug was to blame.
Around 400,000 UK patients were prescribed the drug.
Over 106.7m prescriptions were given to patients in the
US.
However, the UK's Arthritis Research Campaign called the
latest Lancet study results "shocking".
'Increased risk'
Vioxx, (rofecoxib) was removed from the market by Merck
in September last year after research found an increased
risk of heart attack and stroke.
The drug belongs to a class of drugs called Cox-2
inhibitors which are non-steroidal anti-inflammatory
drugs (NSAIDs).
The FDA study analysed data from 1.4m people in
California who had used Vioxx, another Cox-2 called
celecoxib (Celebrex) or other NSAIDs between 1999 and
September last year.
The researchers found 40,000 had used celecoxib, just
under a million had used ibuprofen, 435,000 naproxen and
27,000 Vioxx.
| It seems likely that many people with arthritis in this
country will probably have suffered heart attacks too |
Jane Tadman
Arthritis Research Campaign |
They found that 8,143 had serious heart disease, 1,508
of whom had sudden cardiac death.
When the researchers examined the risk of heart problems
linked to each drug, they found people taking Vioxx had
a 34% higher chance of coronary heart disease when
compared to people taking other NSAIDs.
Coronary heart disease was 1.6 times higher among people
taking standard dose Vioxx compared to those taking
celecoxib and 3.6 times more likely among those taking a
higher dose.
Writing in the Lancet, the lead researcher Dr David
Graham, from the FDA's Office of Drug Safety, said:
"While this report was in preparation, rofecoxib (Vioxx)
was withdrawn from the market by the manufacturer.
"We should assess the potential public health effects of
failure to take earlier action.
"In the future, when trials show that a new treatment
confers a greater risk of a serious adverse effect than
a standard treatment, we must be much more careful about
allowing its unrestrained use."
Doubt remains
Professor David Webb of the University of Edinburgh's
Clinical Pharmacology Unit, told the BBC News website:
"One of the important things is that we might have known
about this at an earlier stage.
"It now falls to the manufacturers, under the careful
review of the regulatory authorities, to provide all the
evidence that this class of drug is safe, if necessary
including studies that directly address cardiovascular
morbidity as a primary outcome."
The study also found that people taking naproxen had a
14% increased risk of heart disease compared to those
taking other painkillers, contrary to previous research
which had suggested it had a protective effect.
However, Professor Webb said: "What this study shows is
that NSAIDs don't have a protective effect. It was a
relative result compared to drugs like Vioxx."
Jane Tadman, of the Arthritis Research Campaign, said:
"These findings in the Lancet are shocking.
"Around 400,000 people were taking Vioxx in the UK at
the time the drug was withdrawn, so it seems likely that
many people with arthritis in this country will probably
have suffered heart attacks too.
"This data adds further weight to calls that Vioxx
should have been withdrawn from sale several years
earlier than September 2004."
European safety regulators are currently investigating
concerns other Cox-2s could also be linked to an
increased heart attack and stroke risk.
Ms Tadman said: "There still remains considerable doubt
about the whole class of COX-2 drugs, with some doctors
no longer prescribing them to patients while others
continue to do so."
The current advice says GPs can prescribe Cox-2s to
arthritis patients who are not at risk of heart attack
and stroke, but Ms Tadman said some at-risk patients
were still being put on COX-2s.
The UK's Medicines and Healthcare products Regulatory
Agency will look at this new study as part of the
ongoing review of Cox-2 inhibitors."
Mo Atachia, spokesman for Arthritis Care, added: "This
report paints a distressing picture. Thousands of people
with arthritis find living with the condition difficult
enough as it is.
"The stress this kind of news brings is quite simply
unbearable."
He added: "It's essential that the European safety
regulators deliver swift a verdict as possible on the
whole class of Cox-2 treatments."
Merck has always said it has acted responsibly and
appropriately in the way it developed and marketed
Vioxx.
Responding to the predictions of heart disease risk in
the Lancet the study, a spokeswoman told BBC News: "You
can't do that with the extrapolation of the data.
"There are many risk factors for heart disease and
stroke.
"To determine whether Vioxx was responsible for any, you
would have to look at patients on a case by case basis."
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