The federal Food and Drug Administration
has asked Pfizer Inc., the maker of the painkiller Bextra, to pull the drug
from the market in this country. The company has agreed.
is designed to treat joint pain, inflammation
and stiffness associated with illnesses such as arthritis.
In a health advisory issued this week, the FDA said it had
concluded “that the overall risk vs. benefit profile is unfavorable” – essentially,
that the risks of taking Bextra now outweigh the benefits.
Those risks include
possible cardiovascular problems and “potentially life-threatening skin
reactions,” according to the advisory. In part, FDA officials said they did not
have enough data on how long-term use of Bextra could affect the heart, and
referred to an “increased risk of adverse CV events in short-term coronary
artery bypass surgery trials that FDA believes may be relevant to chronic use.”
The FDA recommended that patients who are now taking Bextra should
contact their physicians and consider alternative treatments.
In addition, the FDA has asked all other
companies that make similar drugs – called COX-2 non-steroidal anti-inflammatory drugs – to revise the labels of their drugs to include a warning about possible serious
side-effects, including cardiovascular problems and gastrointestinal bleeding.
The agency’s health advisory said the drugs in the second warning
included the popular pain medication Celebrex, also made by Pfizer Inc. Other
warnings are being ordered for over-the-counter painkillers that contain
ibruprofen, a group that includes the popular drug Advil.
Since mid-2004, the agency and other scientists have issued a
series of warnings about prescription and over-the-counter painkillers.
Merck announced Sept. 30, 2004, that it would pull
the popular arthritis and pain medicine Vioxx off
the market worldwide after a study determined it could cause an increased risk
of heart attack and stroke.
problems showed up in some patients starting 18 months after receiving
treatment with Vioxx, drug company officials said. Before that, the medication
had been on the market in the United States since 1999 and was now marketed in
more than 80 countries.
Then, in November 2004, Pennsylvania scientist Garret A.
Fitzgerald told a conference of the American Heart Association that the
painkiller Bextra could pose an even greater risk of heart attack or stroke
That was followed by an FDA announcement that the agency
would require a boxed warning label on bottles of Bextra strengthening previous
warnings about the risk of “life-threatening skin reactions.” The warnings
added at that time also recommended that coronary artery bypass patients avoid
Then, on Dec. 20, 2004, the National Institutes of Health announced it
had halted a national trial looking at ways to prevent Alzheimer’s disease that included naproxen – known by the
brand name Aleve – and celecoxib – known by the brand name Celebrex.
“Data from the … trial indicated an apparent increase in
cardiovascular and cerebrovascular events among the participants taking
naproxen when compared with those on placebo,” according to an Institutes
The FDA quickly followed the National Institutes
announcement, issuing a warning about the popular painkiller.
and Drug Administration is working with the National Institutes of Health to
review the available scientific information on naproxen,” the statement read.
“In the meantime, FDA advises patients who are currently taking
over-the-counter naproxen products to carefully follow the instructions on the
The Institutes’ study did
not show a similar increase in cardiac problems with the use of Celebrex.
However, concerns had already been raised regarding that drug in one of two
--by Mark H. Reddig, associate editor