Chantix Appears on FDA Safety List

Washington, DCThe inclusion of Chantix on a new watch list released yesterday by the US Food and Drug Administration (FDA) adds weight to the potential for Chantix suicide and various other Chantix side effects associated with the smoking cessation drug. Chantix warnings appear to have outdistanced any positive undertones surrounding Chantix since the Pfizer product was brought to market amidst much fanfare just a few short years ago.

Chantix, which is sold as Champix outside the US, works by targeting neuro receptors in the brain that respond to nicotine. It was felt at the time the product was brought to market that Chantix was a clear breakthrough for smoking cessation patients caught up with the clearly daunting challenge of breaking the nicotine habit.

However, it wasn't long before reports of suicide ideation (suicidal thoughts), actual suicides and other adverse reactions prompted a wary stance against Chantix. Part of the problem has to do with the sheer difficulty involved with giving up what for some people is a decades-long habit. The process of quitting has proven to be much more difficult for some.

Thus, the debate rages: is Chantix bad medicine, or is it getting a bad rap from its association with a process fraught with difficulty?

This month the scrutiny for Chantix became just a little more intense after the FDA included Pfizer's stop-smoking aid on a safety list that features various products, together with a summary of identified side effects.

The list was updated June 4th and released yesterday, according to the Washington Drug Letter dated June 15th 2009.

This latest update of the FDA safety list is a reflection of adverse reaction reports covering the final quarter of 2008. Early that year, in February of 2008 the FDA issued a public health advisory about safety warnings for the product, driven by reports of 491 cases of suicidal thoughts and 39 reports of suicides worldwide.

Now, Chantix is making an appearance on the "Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System" list due to red flags concerning angioedema, serious skin reactions, visual impairment and accidental injury. The FDA says it is continuing to evaluate those issues to determine the need for any regulatory action.

According to the Washington Drug Letter, the FDA stresses in a statement that while the agency has identified a potential safety issue, it does not necessarily suggest imminent harm.

"It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk," the agency said in the statement. "(The) FDA wants to emphasize that the listing of a drug and a potential safety issue on this web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication."

The listing for Chantix does not refer to suicide or suicide ideation.

No adverse reaction from any drug can be taken lightly. However, the potential for Chantix suicide and other Chantix side effects can be worrisome—especially for patients who attempt to quit smoking with Chantix without benefit of ongoing counseling. Chantix warnings now include recommendations that doctors carefully evaluate patients before prescribing Chantix, and closely monitor their progress.