In
2008 The FDA announced a public health advisory about
abnormal behavior, agitation, Chantix depression, suicidal ideation, and actual
suicidal behavior with Pfizer’s anti-smoking drug. The FDA provided updated
numbers - 491 cases of suicidal thinking or behavior, including 420 in the US
and of those, there were 39 suicides, including 34 in the US. Many of the cases were reported for patients
without any prior history of psychiatric illness. Government scientists
are conducting further investigating into the drug and, specifically, the
reports of Chantix suicide and suicidal ideation. Chantix, approved in 2006, works
by blocking nicotine receptors to the brain. Chantix is the first such nicotine
receptor partial agonist approved by the FDA. It was heralded as an alternative
to other smoking cessation drugs and nicotine replacement therapy.
Following
the FDA’s inquiry, Pfizer updated the drug’s label on November 20 to indicate
that Chantix side effects include “reports of depressed mood, agitation,
changes in behavior, suicidal ideation (thoughts) and suicide in patients
attempting to quit smoking while taking Chantix.” However, the warnings remain
vague, and many believe that Pfizer is still not doing enough to warn users
about the potentially life-threatening behavior and mood changes which could be
caused by the drug.
In
May of this year, the FDA announced that it asked drug maker, Pfizer Inc., to
submit, again, a large amount of its adverse event reports from 2010 for Chantix, its stop smoking
medication, said the Wall Street Journal. On its website, the FDA wrote that it became aware that Pfizer
and some other drug makers that remain unnamed, have been processing adverse
event reports through what the agency described as “improper” channels, wrote
the Journal. The FDA’s black box warning states
that Chantix increases the risk for neuropsychiatric events such as “suicidal
thoughts or actions,” quoted the Journal. The agency also said it continues to
monitor Chantix safety and initiated two new safety studies with the Department
of Defense and the Veterans Administration. The job of Chantix lawyers now, is
to figure out what side effects are the result of nicotine withdrawal and what
result from taking Chantix.
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