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VA Warned of Chantix Danger in 2007

Jul 8, 2008 | Parker Waichman LLP

The Department of Veterans Affairs (VA) was warned by its own doctors in 2007 that some veterans using the smoking cessation drug Chantix had experienced psychotic episodes and other bizarre behavior.  Yet it wasn't until last month that the VA informed veterans using Chantix that the drug was linked to suicide and other psychiatric side effects.  

A few weeks ago, ABC News aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with  post traumatic stress disorder (PTSD) - had not been told that the drug was linked to depression, suicide and psychotic behavior.  According to the ABC News report, hundreds of  Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month  to participate in a Chantix behavioral study.  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.

Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter  that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.   Peake also said  he has asked VA doctors to review “the communications process” involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD by the VA.

But it now appears that doctors at the VA were concerned about Chantix side effect reports months before the FDA issued its November Chantix Early Communication.  According to the Washington Times, doctors at the VA were getting reports of disturbing behavior among some Chantix users in early 2007.  By November, the VA had data that indicate that nearly one out of every 1,000 veterans taking Chantix had been hospitalized for severe psychosis, a rate noticeably higher than for veterans trying to stop smoking with alternative treatments like nicotine replacement, the documents show.

Even with those disturbing numbers, the VA was prescribing Chantix to more and more veterans - and it was continuing to enroll vets with PTSD in the Chantix behavioral study.  The VA has since acknowledge that the rate serious side effects among PTSD patients in that trial was about one out of every two veterans.

Faced with mounting reports of psychiatric side effects, the VA began an investigation in November 2007, which took the agency 4 months to complete.  That review found that among 27 patients taking Chantix who were admitted to VA hospitals for psychiatric problems since the drug was approved for the market in 2006, 11 had attempted suicide, one attempted homicide, nine had suicidal thoughts, and six were suffering from hallucinations.  The rate of such hospitalizations for Chantix users - about 9.8 for every 10,000 patients - was much higher than it was among veterans using other  smoking cessation methods.  By the time the VA report was completed in March 2008, the FDA had already issued several Chantix warnings, and the drug's labeling was updated to make warnings on suicide and other psychiatric side effects more prominent.

But the VA did not make its Chantix study public, and officials who conducted it never recommended that veterans taking the drug be issued a warning.  It wasn't until May that the agency sent out a letter telling veterans that they should be careful operating heavy machinery if they are taking Chantix.  Finally, on June 18 - after ABC News aired its report -  the VA finally sent out letters to all veterans taking the drug to specifically warn them that suicidal tendencies were a possible side effect.

Tomorrow, a Congressional committee will be looking at the VA's handling of the Chantix debacle.  Those scheduled to testify at the hearing include  VA Secretary James B. Peake and Dr. John D. Daigh, assistant inspector general. Lawmakers will be wanting an explanation for the VA's long delay in warning veterans about the dangers associated with Chantix.


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