FDA Continues to Advocate Caution Over Chantix

Washington, DCThe last thing the US Food and Drug Administration (FDA) wants is to advocate that people stop taking Chantix. Rather, in the face of risk for Chantix suicide and various other Chantix side effects the various FDA warnings since 2007 is an effort to see an increase in patient monitoring. Chantix warnings now include a black box warning.

The Wall Street Journal (WSJ) Health Blog of July 1st reminds us that Chantix was originally hailed as Pfizer's fastest drug launch.

However, events of the last few years have tamed the excitement. According to the WSJ sales of Chantix were down 30 percent in 2008 when compared to a year earlier. Chantix has also been banned for use by commercial airline pilots and air traffic controllers.

And various investigations surrounding the drug's suspected risk for suicide and other Chantix side effects have been undertaken since 2007 when both US and European regulators began heightened oversight into Chantix.

According to the WSJ the US federal regulator's adverse events reporting system has revealed 98 actual suicides and 188 attempted suicides involving patients actively taking Chantix. Thus, the black box warning over concern for potential changes in behavior including hostility, agitation, depressed mood, suicidal thoughts, suicidal behavior and
actual suicide.

It should be noted that the challenge to put an end to what is sometimes a lifelong habit is difficult enough. According to the WSJ Health Blog the FDA notes that many of the aforementioned symptoms sometimes occur in people who are attempting to stop smoking without medication. Thus the rigors of nicotine withdrawal in isolation further complicate the affect a smoking cessation medication has on an individual.

For its part Pfizer, according to the WSJ, intends to conduct a study to determine the rates of adverse reactions and whether particular subgroups are more likely to be affected. Those who suffer from a mental illness, for example is one sub group likely to be studied.

It is generally held that Chantix affects different people in different ways. The husband of a contributor to the WSJ Health Blog comment section reveals that her husband was diagnosed with severe depression, but did fine on Chantix. Yet another responder wrote, "I thought I was going to die," while on Chantix.

For its part the FDA, while continuing to monitor Chantix suicide, advocates caution due to potential Chantix side effects. Hence, the Chantix warnings continue.