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Review of VA Chantix Study Shows Agency Failed Vets

Sep 24, 2008 | Parker Waichman LLP

A review of a Chantix study conducted in cooperation with the Department of Veterans Affairs (VA) has found that the VA was responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers in the experiment.  The Chantix study used veterans suffering from post traumatic stress disorder (PTSD) as test subject.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Over the summer, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with  PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior.  Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide.  It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted.  But even then, the VA’s notice didn’t specifically mention suicide.

The ABC News/Washington Times report sparked an outcry, and Congress ordered the VA to conduct an internal review of the Chantix study.  The review, which was released Friday by  the VA's Office of Research Oversight (ORO), points out that Chantix was "newly approved by the FDA for smoking cessation when it became available for use by [the study's] participants, and it had not been formally evaluated in a comparable study population."

The review  found that no system was in place to warn veterans when the FDA issues new warnings that drugs they are taking might cause serious side effects. Researchers responsible for the study first failed to notify internal review boards that oversaw the experiment when the FDA first publicized its concerns in November.  When a second warning was issued in February, it took 16 to 134 days to alert veterans.

The review also found monitoring of the studies at 10 different sites to be an "unacceptable failure" and that review boards did not investigate some 26 "serious adverse events" that some participants experienced.

Despite the problems with VA Chantix study, it is still ongoing.  As of Feb. 1, when the FDA issued its warning, 120 participants were still taking Chantix. All except 27 have signed an addendum referencing the newest warnings and nine have dropped out of the study, the VA said.


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