Pfizer Inc. says it has found an increased risk of heart problems with
patients taking its painkiller Celebrex, a drug that is in the same class
as Vioxx, which was pulled from the market in September because of safety
concerns.
Pfizer announced Friday that it found the increased risk in one of two
long-term cancer prevention trials, while the other trial showed no
increased risk. The company was conducting the trials as part of an effort
to find a new application for the drug.
The National Cancer Institute, which was conducting the study for
Pfizer, suspended the use of Celebrex after finding that patients taking
400mg to 800mg of the drug daily were found to have a risk of 2.5 times
greater of experiencing heart problems than those who weren't. A separate
cancer study found no increased heart risk with patients taking 400mg of
Celebrex per day.
"I think many doctors have already 'triaged,' if you will, their
patients who are on it, deciding who's appropriate to stay on it and who's
not appropriate to stay on it," CBS News Health Correspondent Dr. Emily
Senay said.
The news sent the stock of the giant pharmaceutical maker plunging in
early trading on the New York Stock Exchange.
Pfizer said it has no plans to pull the drug from the market. Celebrex
is currently approved for use in the United States for the treatment of
arthritis and pain.
"Pfizer is taking immediate steps to fully understand the results and
rapidly communicate new information to regulators, physicians and patients
around the world," said Hank McKinnell, Pfizer chairman and chief
executive officer, in a statement.
"I think the reason they're releasing this information is they want to
be perceived as having full disclosure, not withholding anything," said
Senay. "They want doctors to have this information, and this information,
even though it's conflicting, is helpful for doctors."
Earlier this month, the Food and Drug Administration said it was adding
a warning to the labels of another Pfizer drug, Bextra, warning of
potential heart problems associated with the use of that drug in people
who have recently had heart bypass surgery.
"We know that this happens in some people, it's real," said Senay.
"It's always a problem when the you need to weigh the risk versus the
benefit, and that's what this question is about."
Bextra, Celebrex and Vioxx are all in a class of pain drugs
called cox-2 inhibitors. The drugs have become popular because of their
effectiveness in treating the pain of arthritis and other ailments.
A study released earlier this month suggested that the top-selling pain
reliever does not carry the same heart attack risk as Vioxx, a similar
drug pulled from the market in September because of safety concerns.
The study by researchers at the University of Pennsylvania was the
first to compare the two arthritis drugs since the recall, and contradicts
claims by other scientists that all so-called cox-2 inhibitors may carry
similar dangers.
"Vioxx and Celebrex look different. Relative to Celebrex, Vioxx had
about a threefold greater risk of heart attacks," said Dr. Stephen Kimmel,
associate professor of medicine and epidemiology and lead author of the
study. "What that implies is that all cox-2 inhibitors may not be the
same."
The chances of having a heart attack were 2.72 times greater in Vioxx
users than in Celebrex users, the researchers said.
But the researchers also found that patients using either drug were not
at a significantly greater risk of having a heart attack than those who
did not use either drug. In fact, Celebrex users had a lower risk of a
heart attack than people who didn't take either drug, though the
researchers said that finding could have happened by chance.
In an accompanying editorial, two Boston doctors warned that the
connection between heart disease and cox-2 inhibitors remains unclear. As
a result, they recommended that doctors avoid prescribing any drug in that
class to patients already in danger of heart disease, unless they run a
significant risk of gastrointestinal problems. Cox-2 inhibitors are
believed to be easier on the stomach than other pain relievers.
"We don't think that we really understand what is triggering the
increased risk of heart problems in some patients," said Dr. Axel Finckh,
rheumatology researcher at Brigham and Women's Hospital. "We cannot
exclude the possibility that there is a cox-2 class effect."
"Vioxx had a study that clearly showed double the risk of
cardiovascular events. Now, it looks like Celebrex also has a study that
shows two-and-a-half times the risk of cardiovascular events in one
particular study, and then no risk in another study," said Senay.
Merck & Co. pulled Vioxx from the market Sept. 30 after a study
indicated the popular pain reliever doubled the risk of heart attacks and
stroke when taken for longer than 18 months.
In October, sales of the Pfizer Inc. drug Celebrex topped $260 million,
or 63.5 percent of the market for cox-2 inhibitors, according to IMS
Health data.
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Welcome Out of State Celebrex Users
We have established a nationwide network of aggressive and
experienced product liability attorneys who will evaluate free and
without obligation, your claim for compensation against Pfizer.
Call 800-437-2571 anytime for a
referral to a Celebrex attorney in your area or use our convenient Free
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