Chantix, Psychiatric Risks and the FDA

Dopamine→Psychiatric Illness:

The role of dopamine in treating psychiatric illness is well documented. A few examples:

• Antipsychotic medications are dopamine-lowering medications utilized for the treatment of both psychosis and schizophrenia.
• Risperdal (risperidone), a dopamine-reducing drug, is used for both bipolar disorder and major depression treatment.
• MAOI's (Monoamine Oxidase Inhibitors) are classified into two groups: MAO-A and MAO-B. The MAO-B, specifically, works as a dopamine-increasing medication. For both MAO classes, when taken in combination with any other medication that acts on epinephrine, norepinephrine or dopamine, they must be given at very low dosages in order to maintain their antidepressant effects.
• Some SNRI's (Selective Norepinephrine Reuptake Inhibitors) like Effexor can weakly inhibit the reuptake of dopamine. When taken at high dosages, other SNRI's (Cymbalta) can also reuptake dopamine.
• Bupropion's (Wellbutrin) inhibit the reuptake of both norepinephrine and dopamine. (Zyban, another smoking cessation drug, is a bupropion.)

Upon even a mini-review of the role of dopamine in psychiatric medications, it becomes clear that dopamine levels require monitoring-no matter how low the dosage. Too much or too little dopamine is what creates mood and behavioral disturbances. (At this point no studies point to contraindications for benzodiazepines [the main anti-anxieties in use like Xanax, Klonopin, Restoril, and Ativan] and dopamine-only that they both activate the pleasure centers in the brain. The same holds true for SSRI's [Selective Serotonin Reuptake Inhibitors]. In fact, many believe that some SSRI's actually lower the amount of dopamine released. In any case, any increase in dopamine needs to be monitored.)

For the FDA to essentially ignore the basic side-effect profile of dopamine at the outset when approving this drug and not insist upon some type of clear warning or that those with psychiatric illnesses were at greater risk (and also not studied), I feel they did the mental health community at large a grave disservice. In light of the expanding knowledge of "dual-diagnosis (abuse/addiction co-occurring with mental illness) we would be a population to consider when highlighting the risk factors for a smoking-cessation drug.

On the other hand, for a pharmaceutical company to acknowledge and intensify its warning information (even with the added emphasis that no direct link has been established) continues to clear the way for increased public attention to mental health in general as well as illness. Even a seemingly benign smoking-cessation drug can severely affect mood and behavior.

Although it took less than a year on the market for the truth to come out, this has been almost a year of unnecessary grief for far too many people who thought they were making an informed choice.

[1] "Public Health Advisory-Important Information on Chantix (varenicline)" February 1, 2008, U.S. Food and Drug Administration