FDA Issues Public Health
Advisory on
Vioxx as its Manufacturer Voluntarily Withdraws the Product
The Food and Drug Administration (FDA)
today acknowledged the voluntary withdrawal from the market of Vioxx
(chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID)
manufactured by Merck & Co. FDA today also issued a Public Health Advisory
to inform patients of this action and to advise them to consult with a
physician about alternative medications.
Merck is withdrawing Vioxx from the market
after the data safety monitoring board overseeing a long-term study of the
drug recommended that the study be halted because of an increased risk of
serious cardiovascular events, including heart attacks and strokes, among
study patients taking Vioxx compared to patients receiving placebo. The
study was being done in patients at risk of developing recurrent colon
polyps.
"Merck did the right thing by promptly
reporting these findings to FDA and voluntarily withdrawing the product
from the market," said Acting FDA Commissioner Dr. Lester M. Crawford.
"Although the risk that an individual patient would have a heart attack or
stroke related to Vioxx is very small, the study that was halted suggests
that, overall, patients taking the drug chronically face twice the risk of
a heart attack compared to patients receiving a placebo."
Dr. Crawford added that FDA will closely
monitor other drugs in this class for similar side effects. "All of the
NSAID drugs have risks when taken chronically, especially of
gastrointestinal bleeding, but also liver and kidney toxicity. They should
only be used continuously under the supervision of a physician."
FDA approved Vioxx in 1999 for the
reduction of pain and inflammation caused by osteoarthritis, as well as
for acute pain in adults and for the treatment of menstrual pain. It was
the second of a new kind of NSAID (Cox-2 selective) approved by FDA.
Subsequently, FDA approved Vioxx to treat the signs and symptoms of
rheumatoid arthritis in adults and children.
At the time that Vioxx and other Cox-2
selective NSAIDs were approved, it was hoped that they would have a lower
risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as
ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a
lower rate of these side effects.
Merck contacted FDA on September 27, 2004,
to request a meeting and to advise the agency that the long-term study of
Vioxx in patients at increased risk of colon polyps had been halted. Merck
and FDA officials met the next day, September 28, and during that meeting
the company informed FDA of its decision to remove Vioxx from the market voluntarily.
In June 2000, Merck submitted to FDA a
safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that
found an increased risk of serious cardiovascular events, including heart
attacks and strokes, in patients taking Vioxx compared to patients taking
naproxen. After reviewing the results of the VIGOR study and other
available data from controlled clinical trials, FDA consulted with its
Arthritis Advisory Committee in February 2001 regarding the clinical
interpretation of this new safety information. In April 2002, FDA
implemented labeling changes to reflect the findings from the VIGOR study.
The labeling changes included information about the increase in risk of
cardiovascular events, including heart attack and stroke.
Recently other studies in patients taking
Vioxx have also suggested an increased risk of cardiovascular events. FDA
was in the process of carefully reviewing these results, to determine
whether further labeling changes were warranted, when Merck informed the
agency of the results of the new trial and its decision to withdraw Vioxx
from the market.
Additional information about this
withdrawal of Vioxx, as well as questions and answers for patients, is
available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.
