Two more popular painkillers are in the public
spotlight after reports surfaced about possible links to cardiac problems.
Neither of the two painkillers, Celebrex and Aleve,
have been pulled from the market. News of possible cardiac problems follow
similar concerns about Bextra, which will now carry a warning label, and Vioxx,
which has been pulled from the market.
The National Institutes of Health announced Dec. 20
that it had halted a study that included naproxen – known by the brand name Aleve – and celecoxib – known by the brand name
Celebrex. The study, a national trial looking at ways to prevent Alzheimer’s
disease, was sponsored by the National Institute on Aging, which is part of the
National Institutes of Health.
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 statement.
step is being taken as a precautionary measure to ensure the safety of the
study’s participants,” Dr. Elias A. Zerhouni, director of the National
Institutes of Health, said in a statement. “The investigators made their
decision based on the risk/benefit analysis specific to this trial.”
The federal Food and Drug Administration quickly
followed the National Institutes announcement, issuing a warning about the
“The Food 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 label. Patients should not exceed the recommended doses for
naproxen (220 milligrams twice daily) and should not take naproxen for longer
than ten days unless a physician directs otherwise.”
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 recent studies.
“One of the studies demonstrated an increased
cardiovascular risk over placebo,” Pfizer, the company that produces Celebrex,
said in a statement, “while the other trial revealed no greater cardiovascular
risk than placebo.”
Although Pfizer stands by the safety of the drug – and
only one of three recent studies shows an increased risk for those using the
drug – The New York Times reported
that the company has pulled all advertising of the painkiller
current flood of painkiller concerns follows action by the FDA, which announced
recently it would require a warning label on bottles of Bextra, a prescription
to treat joint pain, inflammation and stiffness associated with illnesses such
new “boxed” warning will strengthen previous warnings about the risk of
“life-threatening skin reactions” and also warn patients who are undergoing
coronary artery bypass graft surgery to avoid the drug.
FDA noted in a “talking paper” that a study conducted by Pfizer, the maker of
Bextra, showed an “increased cardiovascular risk,” including higher numbers of
heart attacks, strokes and other coronary events in bypass patients who used
the drug after surgery.
Merck, the maker of Vioxx, pulled that popular
arthritis and pain medicine off the market worldwide in September after a study
determined it could cause an increased risk of heart attack and stroke.
The problems with Vioxx showed up in some patients
starting 18 months after receiving treatment with the drug, Merck officials
said. Vioxx has been on the market in the United States since 1999 and was
marketed in more than 80 countries.