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Senior Citizen Health & Medicine
FDA Causes Unnecessary Scare about Common
Painkillers, Says Expert
Med school doc says they got it wrong on naproxen
(Aleve)
April 25, 2007 - The U.S. Food and Drug
Administration has caused an unnecessary scare about some pain relievers
by adding a warning to drugs that are safe, says Curt Furberg, M.D.,
Ph.D., from Wake Forest University School of Medicine. At the same time,
he says the agency has failed to recognize the harm of a pain reliever
that should be taken off the market.
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“The FDA is adding ‘black box’ warnings to all
prescription and over-the-counter pain relievers – even to naproxen
(Aleve) – which the evidence shows is safe,” said Furberg, who serves on
the FDA Drug Safety and Risk Management Advisory Committee.
"This is based on the false assumption that all
nonsteroidal anti-inflammatory drugs increase the risk of heart attacks.
In fact, there are major differences between these agents.”
Furberg is widely recognized as a drug safety
expert and has served on the FDA Drug Safety and Risk Management
Advisory Committee. In 2004, he was awarded a Rockefeller Foundation
Residency to gather information about drug costs around the world,
according to a news release from the medical school.
In a commentary published by Trials (click
to view), an online journal of BioMed Central, Furberg says the FDA
has failed to recognize current scientific evidence when it made
decisions on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs)
that are often used to treat the pain or inflammation from arthritis.
The most commonly used NSAIDs are ibuprofen
(Advil), naproxen (Aleve), and diclofenac (Voltaren). There are more
than a dozen others, including drugs such as celecoxib (Celebrex) that
are in a special class known as selective COX-2 inhibitors because of
the hormone they target. The other NSAIDs are known as “non-selective.”
Furberg said while the evidence for the
non-selective NSAIDs is somewhat limited, an analysis combining several
small studies found that high doses (500 mg twice daily) of Aleve were
not associated with an increased risk of heart attacks compared to a
placebo, or an inactive pill.
On the other hand, high doses of Advil (800 mg
three times a day) and Voltaren (75 mg twice daily) were associated with
rates of heart attack that were 51 percent and 63 percent higher,
respectively, than placebo.
An analysis of a large number of trials comparing
COX-2 inhibitors to other NSAIDs found similar results – that Voltaren
was estimated to increase vascular risk by about 70 percent over Aleve.
“Naproxen does not increase the risk of heart
attacks and ought to be a painkiller of choice,” said Furberg. “On the
other hand, Voltaren carries the same risk as the harmful COX-2
inhibitors Bextra and Vioxx, which have been taken off the market.
“The FDA has failed to recognize the evidence that
the risk of heart attack varies substantially among this group of drugs
and that Voltaren has the highest risk of all. Since it is the most
commonly used NSAID, the unrecognized harm it has caused worldwide could
be enormous.”
The European Regulatory Agency has reviewed the
same evidence that the FDA considered and reached entirely different
conclusions, said Furberg. He said this suggests that the decisions are
not based on scientific evidence.
With Celebrex, the FDA didn’t follow the
recommendations of its Advisory Committee to substantially restrict the
drug’s use. Instead, it required only a “vaguely worded” black box
warning, said Furberg.
European countries require clear warnings for
patients at high risk of heart attacks and have said COX-2 inhibitors
should not be taken by patients with heart disease.
With the non-selective NSAIDs, Europe has given a
“clean bill of health” to the agents and the FDA has judged them to have
similar risks to Celebrex and is adding “black box” warnings.
“Decisions by regulatory agencies are expected to
follow explicit regulations and should be evidence-based,” said Furberg.
“Scientific studies point to clinically important differences among the
non-selective NSAIDs, which the FDA has not recognized. It’s time for
the FDA to set the record straight.”
Editor's Notes:
Wake Forest University Baptist Medical Center is
an academic health system comprised of North Carolina Baptist Hospital
and Wake Forest University Health Sciences, which operates the
university’s School of Medicine. U.S. News & World Report ranks Wake
Forest University School of Medicine 18th in primary care and 44th in
research among the nation's medical schools. It ranks 35th in research
funding by the National Institutes of Health. Almost 150 members of the
medical school faculty are listed in Best Doctors in America.
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