- Pfizer Inc. on Friday said 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. A government-sponsored cancer-prevention
trial of Celebrex was halted after patients taking it had more than twice
as many heart attacks as patients taking a placebo.
-
- Pfizer announced 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.
-
- Pfizer said there were no plans to withdraw Celebrex
from the marketplace.
-
- The National Cancer Institute, which was conducting the
study for Pfizer, suspended use of the drug after finding that patients
taking 400 mg to 800 mg of Celebrex daily had a 2.5 times greater risk
of major heart problems than those who were not. A separate cancer study
found no increased heart risk with patients taking 400 mg of Celebrex per
day.
-
- Celebrex is currently approved for use in the United
States for the treatment of arthritis and pain.
-
- Officials at the Food and Drug Administration were not
immediately available for comment.
-
- Previous warnings
-
- Earlier this month, the FDA said it was adding a warning
to the labels of another Pfizer drug, Bextra, alerting consumers to potential
heart problems associated with the use of that drug in people who have
recently had heart bypass surgery.
-
- 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 painful
ailments.
-
- The heart-attack findings for Celebrex come only 10 weeks
following Merck & Co.'s recall of its similar arthritis drug, Vioxx,
after a study found the drug doubled the incidence of heart attack and
stroke among patients taking it to prevent colon polyps that cause cancer.
-
- Vioxx and Celebrex both work by selectively blocking
the cox-2 protein that has been linked to inflammation. They were launched
in 1999 and quickly became top-selling drugs, helped by massive television
and print advertising.
-
- 'Does not bode well'
-
- Patients taking the painkiller are advised to contact
their doctors.
-
- "In light of this discouraging news, individuals
who are taking either Celebrex or Bextra should immediately contact their
physician," said Dr. Mark Fendrick of the University of Michigan.
"It would be extremely prudent to avoid taking either Celebrex or
Bextra until we know for sure about their cardiovascular safety."
-
- So far this year, there were 19.8 million prescriptions
filled for Celebrex, 10.9 million for Bextra; and 14 million for Vioxx,
according to IMS, a pharmaceutical consulting company.
-
- "This does not bode well for cox-2 inhibitors in
general, said Ira Loss, an analyst at Washington Analysis. "The sense
had been that Celebrex is somehow different from the others."
-
- In October, sales of Celebrex topped $260 million, or
63.5 percent of the market for cox-2 inhibitors, according to IMS Health
data.
-
- Merck pulled Vioxx from the market Sept. 30 after a study
indicated it doubled the risk of heart attacks and stroke when taken for
longer than 18 months.
-
- Studies done five years ago - when Celebrex and Vioxx
were approved - suggest the same mechanism that inhibits inflammation and
makes the drugs easier on the stomach also blocks a substance that prevents
heart problems, scientists have said.
-
- Dr. Joseph Feczko, president of worldwide development
for Pfizer, noted that the results in the study, which showed increased
risk of heart attacks, were not consistent with either the other cancer-prevention
trial or with a "large body of data" that the company had collected.
-
- "Pfizer is taking immediate steps to fully understand
the results and rapidly communicate new information to regulators, physicians
and patients around the world," Pfizer's chief executive Hank McKinnell
said in a statement.
-
- The Associated Press, Reuters and MSNBC's Jane Weaver
contributed to this report
|
