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Naproxen Class Action Lawsuits Information
Naproxen is part of the class of drugs known as nonsteroidal
anti-inflammatory drugs, or NSAIDs. Manufactured by German drugmaker Bayer and
sold under the brand name Aleve, as well as Roche Palo Alto’s Naprosyn, naproxen
was first sold by prescription in 1976 and was approved for over-the-counter
sales in 1994. The popular over-the-counter drug is used to treat a variety of
ailments, including headaches, menstrual cramps, arthritis and gout. Amidst drug
safety warnings and controversy, naproxen is the latest drug to be added to the
list of questionable medicines.
A subset of NSAIDs, called Cox-2 inhibitors, include the now recalled Merck &
Co. drug Vioxx and Pfizer Inc.’s Celebrex and Bextra. Older drugs like aspirin
can cause stomach bleeding and ulcers so newer Cox-2 drugs were designed to
prevent gastrointestinal side effects. Some medical experts believed naproxen
might have beneficial heart effects. In 2000, when increased heart risks with
Vioxx first surfaced, Merck argued the study results appeared skewed for Vioxx
users only because it was compared to the protective heart effects of naproxen
other patients included in the trial were taking.
Vioxx was recalled four years later on September 30, 2004 in the largest
prescription drug recall of all time after another study showed a significant
increase in risk for heart attack and strokes. Just 11 weeks later, Merck
announced its arthritis drug Celebrex, and Vioxx competitor, showed an increase
for heart risks. Although Pfizer has continued to stand by Celebrex safety and
has kept the drug on the market, on December 20, 2004, Pfizer announced it
stopped advertising Celebrex directly to consumers in response to an FDA
request. Later, the same day, U.S. health regulators warned that heart risks
were also connected to over-the-counter painkiller naproxen.
The naproxen warnings further confused both doctors and patients alike. Stemming
from a National Institutes of Health (NIH) funded trial studying the effects of
Celebrex, naproxen and a placebo in patients at risk for Alzheimer’s disease,
the trial showed patients taking Aleve were found to have about a 50 percent
greater chance of suffering strokes or heart attacks than those taking a
placebo. Just days earlier, the NIH study suspended the use of Celebrex in the
study after FDA warnings were issued. The latest naproxen developments led
researchers to also suspend the use of naproxen among study patients as well.
The NIH late-stage trial began in 2001 and was designed to study 2,625 patients
for up to seven years. The study’s principal investigator, Dr. John Breitner,
said the trial showed a “fairly impressive signal of increased risk of heart
attack and stroke” among naproxen users. Even though the Alzheimer’s study did
not show “significant increases” in risk for cardiac trouble or stroke for
Celebrex patients, the decision to stop using Celebrex in the study was in
response to a different NIH study investigating inflammation as a cause of
cancer that showed Celebrex more than doubled the risk of heart attack and
strokes.
The FDA deputy director of the Office of New Drugs described the naproxen
effects to be “a very confusing situation,” but the agency stopped short of
urging patients to seek alternative treatment methods to naproxen, unlike their
response to Celebrex heart risks findings. FDA officials did urge patients
taking naproxen to following instructions carefully and avoid using the drug for
more than 10 days.
Naproxen Side Effects
On December 20, 2004, the National Institutes of Health (NIH)
announced research investigators were suspending the use of two drugs – naproxen
and Celebrex – from its large, three-arm, national Alzheimer’s disease
prevention trial. Just days after Pfizer Inc. said its best-selling arthritis
drug Celebrex was associated to increased heart risks, the naproxen side effects
announcement was made.
As a precautionary measure, the study investigators made their decision based on
the risk/benefit analysis that was specific to the trial. Up until the recent
naproxen side effects announcement, researchers claim there has been no evidence
that the use of naproxen could cause heart problems. The concerns were prompted
by preliminary findings by the NIH study that showed patients taking naproxen
have about a 50 percent greater chance of suffering strokes or heart attacks
than those taking a placebo.
According to the study’s principal investigator, Dr. John Breitner, there was a
“fairly impressive signal of increased risk of heart attack and stroke” for
naproxen side effects in the study. While more research will need to be
performed to better understand the actual naproxen side effects risks, Breitner
thinks it will be hard to find anyone to take part in placebo-controlled trials
with NSAIDs.
NSAIDs, or nonsteroidal anti-inflammatory drugs, are a class of drugs that
includes over-the-counter drug naproxen, as well as prescription drugs Vioxx,
Celebrex and Bextra. Vioxx, Celebrex and Bextra belong to a subset of NSAID
drugs, called COX-2 inhibitors. At the end of September 2004, Vioxx was recalled
from the market in the largest prescription drug recall because of significant
increased risks of heart attack and strokes. Just after the Vioxx recall,
studies indicated both Bextra and Celebrex also showed links to increased heart
risks, and Bextra labeling was changed in response and Celebrex warnings issued.
The discovery of possible naproxen side effects calls into question if the
adverse effects could be a class wide effect. Preliminary naproxen side effects
have left federal officials, researchers, doctors and patients confused about
the entire situation. Breitner said he has “no knowledge of whether this is
unique to naproxen, or whether it may be a problem for all NSAIDs,” saying that,
“we’ve never had the opportunity to study that.”
Although the FDA issued Celebrex warnings a few days prior, urging patients to
seek alternative drug treatments, drug officials stopped short of doing the same
in light of the possible naproxen side effects. Consumers have been urged to
avoid possible increased risk of naproxen side effects by following label
directions carefully and avoiding taking the drug for more than 10 days.
When the naproxen side effects announcement was made, it was after the stock
markets had closed. Bayer manufacturers name-brand naproxen under the name of
Aleve, and the company said at the time of the announcement it had not yet seen
the data to comment on the study. FDA drug researcher and whistleblower David
Graham told CNN’s “American Morning” that, “over-the-counter drugs are supposed
to be the ones that are absolutely the safest.” Dr. Sandra Kweder, deputy
directory of the FDA’s Office of New Drugs says, “This is a very confusing
situation.”
More Naproxen Information
Recent naproxen information has revealed that this drug may
cause an increased risk of cardiovascular side effects in patients taking even
the over the counter strength of this pain medication. This naproxen information
was announced publicly by the FDA in December 2004 after clinical trials
revealed this potential risk. The National Institute of Health initiated a drug
trial in 2001 to test the effectiveness of some medications in preventing
Alzheimer's disease. This study was halted after naproxen information revealed
that the trial participants taking naproxen were twice as likely to suffer from
heart attack or stroke as patients in the control group.
This clinical trial was testing the effectiveness of both naproxen and a similar
drug called Celebrex on preventing the development of Alzheimer's in study
participants. Naproxen information from this trial revealed that seventy people
suffered a stroke or heart attack out of the 2,500 participants in the naproxen
group. These patients were all seventy years of age or older and had been
prescribed an over the counter strength of naproxen.
Naproxen has been on the market in both over-the-counter and prescription
strengths since the mid-1970s. Naproxen is the generic name for this original
non-steroidal anti-inflammatory drug (NSAID), and therefore all naproxen
information applies to the brand name drugs Aleve, Anaprox, Naprosyn, and
Naprelan. Since these pain medications were first made available almost thirty
years ago, naproxen information from clinical trials has never yielded any
concrete conclusions about the long term cardiovascular safety of naproxen use.
Information about Naproxen's potential to cause gastrointestinal complications
in patients has, however, been well established. Product naproxen information
labeling warns patients that taking naproxen may cause ulcers, intestinal
bleeding and other serious complications. As a result of this naproxen
information, new drugs were developed in the 1990s to effectively treat pain
without these gastrointestinal risks.
These newer NSAIDs were designed to inhibit only one enzyme involved in the
tissue inflammation which causes pain. Compared to naproxen information, these
drugs initially appeared to have a much lower risk of serious side effects such
as gastrointestinal complications. These COX-2 selective drugs have been widely
prescribed as viable alternatives to naproxen and other traditional NSAIDs.
Controversy about these drugs was sparked by the recall of Vioxx, a COX-2
selective NSAID, after studies found that Vioxx patients were at an increased
risk of suffering heart attack or stroke. Patients taking 400 milligrams of
Celebrex, another COX-2 NSAID, have also been shown to be at risk for
cardiovascular problems. Patients taking Bextra may also be twice as likely to
suffer heart attack or stroke, especially after cardiac bypass surgery. Now that
naproxen information has revealed similar cardiovascular risks, the safety of
all NSAIDs has been called into question. Officials are currently looking into
the safety of these pain medications in order to determine the exact nature of
these cardiovascular risks.
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