'Erratic' behavior triggers Chantix probe

When is quitting smoking a bad thing? When you quit with the help of Pfizer's Chantix, and then settle into a depressive funk so bad, you think about killing yourself. That's just what's happening to some patients, according to the FDA, which asked doctors yesterday to start monitoring those who are taking the drug. The agency has received reports from patients and docs, who say Chantix is triggering depression, severe mood swings, abnormal dream states and suicidal thoughts.

Strange, yes. But even stranger is the event that may have triggered the FDA's investigation. In September, a professional musician taking Chantix--possibly in one of those abnormal dream states--hammered on the door of his neighbor's house, screaming bloody murder. The neighbor shot him. The incident made the morning news shows at the time. Could this be the "case report citing erratic behavior" mentioned by the agency in its press release?

Until now, Chantix has largely been a success story. Its sales have climbed steadily since its launch last year, when it hit the ground running so hard that a Pfizer exec called Chantix its fastest launch ever.

- see the release from the FDA
- read this report on the musician's death and Chantix's early performance
- take a look at this Fortune article
- read a firsthand account of Chantix-enhanced dreaming

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.