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Chantix Tested on Vets with PTSD

Jun 17, 2008 | Parker Waichman LLP

A shocking new report alleges that war veterans used as test subjects for Chantix were not told upfront that the anti-smoking drug was linked to suicidal behavior and other psychiatric side effects.  What's worse, some of the Iraq war veterans used as Chantix guinea pigs were suffering from post-traumatic stress disorder (PTSD), a condition that already placed them at a higher risk of suicidal behavior.

In the US, 34 Chantix users have reportedly committed suicide. 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. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.

Now, a joint investigation conducted by ABC News and the "Washington Times" is raising questions about the ethics of some Chantix clinical trials.  James Elliott, a 30-year-old ex-Army sniper diagnosed with PTSD told ABC News that he agreed to participate in a Chantix trial for $30.00 per month.  Months after he began taking the drug, Elliott suffered a mental breakdown, experiencing a relapse of Iraq combat nightmares he blames on Chantix.  

One night this past February, he "snapped" and left home with a loaded gun.  His fiancée called police, concerned because he was acting as though he was still in combat.  Police had no choice but to subdue Elliott with a taser and arrest him.

Three weeks later, the Veterans Administration finally advised the participants in the Chantix study that the drug may cause serious side effects, including "anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide."   By the time that notice went out on February 29, 2008, the FDA had already issued three separate Chantix suicide warnings.  But officials at the Veterans Administration told ABC News that those warnings  "didn't justify an emergency warning at that level."

The same official also told ABC News that the Veterans Administration sees no reason to discontinue the Chantix study.  As it stand right now, about 140 veterans diagnosed with PTSD continue to receive Chantix as part of a smoking cessation study.

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