Recently, the FDA issued the results of two epidemiological studies involving Chantix. The agency sponsored the two studies (observational studies, which means the study takes a backward look at the effects of a drug on patients), both of which indicated that there was no difference in risk of neuropsychiatric hospitilizations between Chantix and nicotine replacement therapy. The message: Chantix doesn't cause people to attempt suicide any worse than other therapies.
So it was interesting to hear yesterday that another study found the complete opposite.
Published in PLoS ONE, the study which analyzed over 3000 case reports of serious injury in the FDA's Adverse Event Reporting System from 1998 through 2010, found that, of the self-injurious behavior linked to Chantix, Zyban and other nicotine replacement products,
90 percent were due to Chantix. The authors of the study stated "two newly released, but unpublished FDA studies of psychiatric hospitalizations provide little useful safety information, because the serious psychiatric side effects of smoking cessation treatment do not normally result in hospitalization. Notably suicide, aggression, depression, and assault would not normally result in hospitalization". Which means the FDA studies don't tell us much, if anything, about the safety of Chantix. It should also be noted that the FDA studies, which were unpublished and therefore could be released at any time, came out just shortly before the study yesterday which was published in PLoS ONE. One wonders whether the timing of the FDA results were orchestrated to soften the blow from the PLoS ONE study? I'm sure it's just my suspicious nature running amok.
Pfizer, maker of Chantix, is conducting its own double blind, gold standard study that will look at these issues and give us some answers. Of course those results won't be out till 2017, just shortly before Pfizer loses the patent on the drug in 2018. Funny how that happens.