Chantix maker Pfizer is planning to start running TV spots for the drug again this weekend, obviously hoping that furor over its possible link to suicidal behavior has died down. Pfizer pulled Chantix TV commercials last year, as concerns over suicide and other side effects grew. One Pfizer executive told Forbes.com that since the ads stopped running, some consumers have been under the impression that Chantix had actually been taken off of the market.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.
But the drug has been the subject of disturbing side effect reports. In the US, Chantix has been linked to dozens of suicides and hundreds of 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.
In May, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, 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.
According to Forbes.com, the new Chantix ads, which begin running on Sunday, feature the same “tortoise and the hare” theme Pfizer used before it stopped advertising the drug. The longer spots now run for 90 seconds, and roughly 41 seconds involve side effect information. About half of that time is devoted to warning that patients taking Chantix should stop taking it if they experience agitation, suicidal thoughts or suicidal behavior. Pfizer says the role of Chantix in those symptoms is “not known.”
It is not unusual for drug makers to rework ads after a safety controversy has erupted. While one expert interviewed by Forbes said she was glad the new Chantix ads will include specific side effect information, she is withholding judgment until she actually sees the spot. “It is good news if the serious risks are now present physically,” Ruth Day, of Medical Cognition Laboratory at Duke University, said. “But are they there functionally–in a way that people will understand and remember them?”
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