About 32,000 veterans taking Chantix will soon receive a warning that the stop-smoking drug is linked to suicidal behavior. The decision by the Veterans Administration (VA) comes after ABC News aired an investigative report which revealed that veterans enrolled in a Chantix trial – all diagnosed with post traumatic stress disorder (PTSD) – were not told for several months that the drug was associated with suicide.
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. 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.
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 airing of the ABC News 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.
Still, the VA will allow the Chantix study using PTSD veterans to continue, however no more participants will be enrolled. Peake said he would not have any problems halting the Chantix study if needed, but insisted that there is no evidence that such a more is necessary.
<You can leave a response, or trackback from your own site.
