SILVER SPRING, Md. (AP) — A majority of federal health
experts said Tuesday that new research is not strong enough to conclude
that naproxen, the pain reliever in Aleve and many other medications, is
safer on the heart than rival drugs used by millions of Americans to
treat arthritis and everyday aches and pains.
The Food and Drug
Administration advisory panel voted 16-9 against the conclusion that
naproxen has a lower risk of heart attack and stroke than similar
anti-inflammatory medications like ibuprofen, sold as Advil and in other
generic formulations.
The drugs, known as non-steroidal
anti-inflammatory drugs or NSAIDs, include over-the-counter medications
like Aleve and Motrin as well as more high-powered prescription drugs
like Celebrex, marketed by Pfizer to treat arthritis. Uniform labeling
across all the drugs warns that they can increase the risk of heart
attack and other life-threatening cardiovascular events. But debate over
whether one drug in the class is actually safer than others has waged
for more than a decade without a clear answer.
The FDA convened a
two-day meeting this week to review the latest evidence, including a
massive analysis published last year suggesting naproxen does not
increase the risk of heart problems as much as its peers. Despite an
apparent "drift" toward fewer heart problems with naproxen, a majority
of panelists said the evidence was not conclusive and did not warrant
changing the drug’s label.
"If I were forced to bet on what the
truth is, my bet would be that naproxen is somewhat safer," said
panelist Dr. Susan Ellenberg of the University of Pennsylvania. "On the
other hand, I’m not sure how that relates to our regulatory standard, as
there’s still a lot of uncertainty here."
Panelists who voted in
favor of naproxen’s safety conceded that the evidence is not definitive,
but also cited a "duty to inform the public."
"I’m convinced
enough to change my own use of NSAIDs to naproxen — and that of my
patients — based on what I’ve heard these last two days," said panelist
Dr. Peter Kaboli of the University of Iowa.
The findings favoring
naproxen came from Oxford University researchers who combined results
from more than 700 NSAID studies and found fewer heart problems with
over-the-counter and prescription naproxen. But most panelists said
those results were difficult to interpret. Known as a meta-analysis, the
process involved combining safety data from roughly 350,000 patients
across hundreds of unrelated studies.
"Meta-analyses are good for raising questions, not for settling them," said panelist Dr. Sanjay
Kaul of UCLA School of Medicine.
Despite
the panel’s opinion against relabeling naproxen, the group did suggest
there was room to update some safety language across all NSAIDs.
Current
labeling suggests that heart risks only appear after 10 or more days of
continuous use. But a recent analysis by Danish researchers found that
heart attack and stroke can occur within less than a week of treatment.
A majority of panelists said the FDA should consider revising the label to warn of this short-term risk.

"Any
suggestion that those first two weeks come for free should be removed
from the label," said panelist Dr. Brendan Everett of Harvard Medical
School.
This week’s FDA meeting is the latest chapter in an
ongoing safety review of NSAIDs that stretches back to 2004, when Merck
& Co Inc. pulled its blockbuster pain reliever Vioxx off the market
because of links to heart attack and stroke.
Vioxx had been
heavily advertised as a new kind of NSAID that was supposed to be easier
on the stomach. But its withdrawal shook the medical establishment and
ushered in a new era of drug safety at the FDA.
In 2005, the
agency added boxed warnings to all prescription NSAIDS, including
Celebrex and high-dose versions of ibuprofen and naproxen. Celebrex is
the only drug from the same class as Vioxx that remains on the market.
The prescription NSAIDs are generally used for long-term chronic pain
conditions like arthritis.
The agency also added similar warnings
to lower-dose, over-the-counter NSAIDs like Aleve and Advil. Those drugs
currently warn patients to take the lowest dose possible for as short a
period as possible.
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