If You're Taking Chantix You Need to Understand the Risks
If your doctor has prescribed Chantix to help you stop smoking, you should
be aware of the serious dangers associated with taking Chantix and carefully
consider whether you are a good candidate for this drug.
Chantix is the brand name for the pharmaceutical drug varenicline that
is intended to help patients quit smoking. Pfizer requested and received
an accelerated review by the FDA and Chantix was approved for use in the
United States in May of 2006. As Pfizer predicted Chantix quickly became
a top selling drug for the company with annual sales of $883 million in
the first full year it was on the market.
In simplified terms, Chantix dulls the sensors in the brain associated
with pleasure, so while Chantix is somewhat effective in reducing the
positive feelings in the brain by blocking the brain receptors commonly
stimulated by nicotine, the impact of the drug on the brain has resulted
in numerous reports of sudden, unusually aggressive behavior, thoughts
of self-harm and suicide.
The Dangerous Side Effects of Chantix
The side effects of Chantix are numerous and varied, some of them very
dangerous. Many critics claim Pfizer failed to properly test the drug,
and did very little to warn consumers of the host of risks when the drug
entered the stream of commerce. More dangerous side effects have been
reported each year the drug has been available for use. Chantix is associated
with and is believed to cause neuropsychiatric injuries characterized
by dramatic behavioral changes. The most dangerous side effects linked
to Chantix are suicide, suicide ideation and psychotic behavior. An alarming
number of Chantix users have taken their own lives or seriously injured
themselves in an attempt at suicide. Others have suffered depression,
anxiety, nervousness, agitation rage and hostility. Chantix is also believed
to cause serious heart rhythm disturbances, such as acute myocardial infarction,
seizures, and muscle disorders. Physical impairment, dizziness, loss of
consciousness, unusual behavior, mood swings, muscle spasms and skin problems
have also been reported.
The Institute for Safe Medication Practices has said that even more problems
are being identified. In addition to the reported heart and cardiovascular
problems that have been previous identified the Institute believes that
there may be an association between Chantix and serious injury accidents
from falls which many suspect is caused by the visual disturbances reported
with Chantix. The Institute also found continued reports of aggression
and suicide. Chantix has also been linked to Stevens Johnson Syndrome,
a potentially deadly skin disease.
Inadequate Drug Testing
Ironically, Chantix began as a success story; early promotional claims
boasted that a significant 44% of people taking Chantix were able to quit
smoking in comparison to 17.7% percent of those taking placebos. By blocking
nicotine from stimulating certain brain receptors, smokers don't get
the dopamine boost they would normally receive when they smoke. But as
the number of reports surfaced of users committing suicide, attempting
suicide or experience sudden aggressive behavior, concerns emerged about
Chantix side effects and whether the benefits outweigh the potential risks.
In November 2007, the FDA initiated a review of emerging safety questions
about Chantix after identifying at least 39 Chantix suicide deaths and
nearly 500 reports of suicidal thoughts. At that time, Pfizer was not
providing any warnings on the label or in advertisements about the potential
Chantix suicide side effects. Not long afterwards the U.S. government
(FAA) banned pilots and air traffic controllers from using Chantix because
of its reported dangerous side effects.
Pfizer pulled all advertisements for Chantix in 2008 due to mounting concerns
of increased suicide risks. In June 2009, a "black box" warning,
the highest level of warning from the FDA, was added to the medication
about the potential risk of problems with Chantix, indicating that some
users have experienced changes in behavior, depression and suicidal thoughts.
Remarkably, Pfizer has since re-launched a national TV campaign for their
stop smoking drug despite the serious dangers associated with taking Chantix.
A number of Chantix lawsuits have already been filed on behalf of people
who took their own life or suffered severe injuries from a suicide attempt
or unusual aggressive behavior while taking the drug. The lawsuits claim
that Pfizer failed to adequately warn about the potential side effects
which allegedly resulted in these injuries.
Lawsuits against Pfizer for injuries suffered from using Chantix allege
that Pfizer failed to effectively study Chantix to determine the risk
of serious injury or death associated with its use, that Pfizer intentionally
excluded certain patients and populations from clinical trials and that
Pfizer intentionally ignored the proper evaluation process. Perhaps blinded
by the potential profit power of a successful stop smoking drug, critics
claim Pfizer simply failed to address frequent reports of depression,
aggression, suicide, suicidal ideation, suicidal thoughts, suicidal tendencies,
and other injuries mentioned above.
Patients now claim that Pfizer is responsible for failing to determine
what other effects Chantix has on other receptors in the human brain and
body, and that they intentionally failed to include appropriate measures
of adverse events in clinical trials.
For example, while studies suggest that nearly half of all cigarettes aresmoked
by people with mental illness, Pfizer admitted that "[p]atients with
serious psychiatric illness such as schizophrenia, bipolar disorder, and
majordepressive disorder did not participate in the controlled clinical
Dr. Daniel Seidman, the director of Smoking Cessation Services at Columbia
University Medical Center, is reported to have said in a recent article,
"When [Pfizer] tested the drug, the sample they chose simply isn't
representative of the people they're targeting. . . . By excluding
drinkers, you're artificially inflating your results, potentially.
I run a clinic, and two out of three [smokers] I see have a psychiatric
or mood problem. None of these people would have been part of the original
Angel Law, P.C. litigates
dangerous drug cases and a Chantix litigation lawyer at Angel Law, P.C. is now investigating
cases involving not only suicides but also cases involving, lethal cardiac
rhythm disturbances, acute myocardial infarction, seizures, and psychosis.
If you or a loved one has used Chantix and has experienced an injury as
a result of any of these symptoms or events, call a Chantix class action
lawyer at Angel Law, P.C.
Click here to
review the warning on Varenicline (Chantix) published by the US National Institute of Health.