FDA Issues Harsher Warnings for Anti-Smoking Drug
> 1/18/2008 12:13:05 PM

Chantix, the Pfizer company's big money smoking-cessation wonder drug, has stumbled under evidence of unfortunate side effects after more than a year on the market and 4 million prescriptions, and the FDA has decided to expand on previously issued warnings that place the future of this promising drug in greater doubt.

Past clinical trials for Chantix have proven encouraging as the drug seems more effective than any previously developed medication in helping heavy long-term smokers fight their habit. 44% of medicated study subjects have "quit" smoking after three months; of course, 12-week efficiency is not always maintained in the long-run long. Pfizer's own data also reports that, after one year of treatment, only 1 in 5 patients was no longer smoking, meaning that the vast majority returned to the habit even after some inital successes. These numbers are actually somewhat impressive when considering the overhwelming challenge posed by smoking cessation.

We've reported on both the initial development and release of Chantix and the official response to public concerns regarding its side effects. Unfortunately, as one may conclude from the responses to our first Chantix post, patients began reporting problems almost immediately following its release.The process of quitting, especially for longtime smokers who attempt to go cold turkey, always entails some degree of mental and emotional instability, usually in the form of anxiety, irritation, sporadic fits of anger, and recurring insomnia. But hundreds of Chanitx patients have reported depression, severe anxiety and thoughts of suicide only days or weeks after beginning their prescriptions. Pfizer's claim that the overall picture painted by these complaints is biased due to pre-existing mental health conditions among the subject pool may be valid. But the prevalence of severe symptoms among Chantix patients was considered a valid cause for concern in the past, and the FDA recently heightened their warnings to explicity list these possible side effects for the benefit of practitioners and their patients.

The changes required by the FDA essentially amount to little beyond the adoption of a larger font size and a more prominent placement of official warnings on the medicine's packaging labels, but they serve to reinforce the general sense of professional uncertainty about what remains a somewhat mysterious drug. The response is somewhat tepid. No ominous black boxes have been issued. But doctors must take note (as any attentive professionals surely have) of the news and plan to examine Chantix patients more extensively for potential side-effects and the resurgence or expansion of pre-existing mental health conditions. This development may lead Pfizer to modify Chantix in some form, and patients should not discount the medicine altogether, but in the meantime all interested parties are advised to take heed.

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