Chantix Suicide Risk Warrants Black Box Warning, Consumer Group SaysApr 3, 2008 | Parker Waichman LLP
Chantix, the smoking cessation drug linked to suicidal behavior and other psychiatric problems, should bear the Food & Drug Administration's (FDA) strongest safety warning, the consumer group Public Citizen says. Earlier this year, warnings of suicide and other behavioral problems seen in some Chantix users were given more prominent placement on the drug's label, but Public Citizen says those warnings are still not strong enough, and wants the FDA to require they be highlighted by a "black box".
Chantix, made by Pfizer Inc., was approved in 2006. Chantix works by blocking nicotine receptors to the brain, and was 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. But soon after it was approved, some Chantix users began exhibiting signs of depression, suicidal thoughts and behavior, and other psychiatric problems.
According to an FDA Nov. 20 Early Communication, Pfizer had submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. At the time, the FDA said that its preliminary assessment revealed that 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. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
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 this safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA is working with Pfizer to finalize a Medication Guide for patients.
Public Citizen, which includes Chantix on its "Worst Pills" listing, wants the FDA to do more. The group is requesting that the FDA require Pfizer to add a "black box" warning about suicide and other psychiatric side effects associated with Chantix on the drug's label. A black box warning is the FDA's most serious type of safety warning. In most cases, when Public Citizen petitions the FDA for a black box warning on a drug, the FDA eventually agrees.
The Public Citizen request is in response to a growing number of adverse reaction reports related to Chantix. According to an analysis of Chantix adverse reactions spanning the first 9 months of 200 conducted by CBS11, the number of adverse events for Chantix rose from nearly 700 in the first 3 months, to a total of 3,700 at the end of the nine-month period. Dr. Sidney Wolfe of Public Citizen also told CBS11 that the FDA data shows an increase in adverse events in early 2007, before the well-publicized death of Dallas musician carter Albrecht, who died in September after taking Chantix. It's believed the pills made him exhibit bizarre behavior resulting in his death.