FDA Investigating Reported Side-Effects of Chantix
> 12/3/2007 9:54:59 AM

Smoking is incredibly difficult to quit, so back in May we reported enthusiastically on the FDA approval of Chantix, the first cessation drug to reduce both cravings and the pleasure of cigarettes. Chantix has helped thousands of people quit, but a steady stream of worrying complaints built up in the comments section of our article. The FDA gave Chantix a priority review, shortening the safety evaluation from 10 to 6 months because the benefit appeared so large and the health risks so small, but last week they sought to rectify any mistakes of haste by issuing an Early Communication.

The Early Communication is not a condemnation, but rather a warning to doctors and patients to be alert for problems. Specifically, the FDA wants people to watch out for suicidal ideation, erratic behavior, and drowsiness so that these symptoms can be treated and also catalogued for study. While the number of reports sent to the FDA already may seem damning, no conclusions can be drawn without additional information.

It is very difficult to determine whether Chantix causes emotional and behavioral changes, because smoking cessation causes a variety of problems on its own. It is important to be familiar with the long list of cessation symptoms so that their appearance does not cause dismay and overreaction. Nicotine is a drug, and withdrawal can cause irritation and mood swings, as well as exacerbate mental illnesses that have been simmering. Many of the people reporting problems with Chantix, including a significant percentage of commenters on our own website, have pre-existing anxiety and depression problems but mistakenly jump to the conclusion that Chantix must be causing the aggravated symptoms they experience after quitting.

Quitting can also cause temporary performance impairment. Most users come to rely on the stimulant properties of nicotine to get them through the day, and many stumble when that crutch is thrown away. Those worried about a lack of concentration and mental acuity should wait until their brains are no longer dependent on a stimulant before dismaying.

Weight gain is unfortunately a risk for those who quit smoking. The health benefit of quitting outweighs the gain of a few extra pounds, but even though these pounds can be worked off through exercise, many people choose appearance over health. It is important to note that no study has ever linked Chantix to weight gain, or even seriously proposed a mechanism by which it could cause such gain.

The purpose of dissecting the faulty reasoning behind all of these fears is not to make light of the concerns of those who are suffering. There may very well be serious side-effects of Chantix that have not yet to come to light. Chantix has a powerful effect on a reward mechanism of the brain, and so could be responsible for a variety of serious problems. It is important, though, that careful reasoning and observation are not discarded for panic. Quitting is an arduous trial, and there are as yet no medications that allow users to skip the difficult stages of withdrawal. As the dangers of smoking are confirmed, and the risk of Chantix is only speculation, people can continue to use the cessation drug as long as they consult a therapist or doctor at the first signs of a problem. Frequent contact between patient and therapist and/or prescribing physician is crucial with any use of cessation medication for safety reasons, and because expert help makes it much easier to quit than medication alone.

No comments yet.

Post Your Comments

Post a comment
Email Address:
Verification Code:
Input the 8 characters you see above:


Drug Abuse
Sexual Addiction
Eating Disorders
Alzheimer's Disease

About TOL | Contact Us | Defining Behavioral Fitness | For Healthcare Professionals | Links | Privacy Policy