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Yesterday the FDA published an article on their website informing the public and physicians that they are currently reviewing the smoking cessation drug Chantix. The FDA says that they have received reports of erratic behavior and suicidal thoughts from Chantix users. The manufacturer, Pfizer, has submitted postmarketing cases of suicidal ideation and behavior. Preliminary observations reveal that many cases seem to suggest the onset of depression, changes in behavior and emotion, and suicidal ideation within days of starting Chantix. The FDA does say that the role Chantix has played in these cases is unclear, as quitting smoking without medication can exacerbate underlying psychiatric disorders.

The FDA commented on the highly publicized shooting death of Carter Albrecht, which has been tied to the adverse effects of Chantix. Albrecht was fatally shot after a very uncharacteristic psychotic act one week after beginning Chantix. His girlfriend has been adamant that Chantix must have induced Albrecht’s action leading directly to his death.

The FDA is also exploring reports of extreme drowsiness associated with Chantix. Some believe this is related to reports of intense vivid dreaming while taking the medication. Reports describe patients who had impaired ability to drive and operate machinery while on Chantix.

Physicians are being urged to carefully monitor behavior and mood changes while on Chantix. Patients are being advised to use caution when driving or operating machinery until they know how the smoking cessation drug will affect them.

This early transmission does not confirm a causal relationship between the drug and any of the above listed side effects, however; the FDA will continue to evaluate potential claims and will inform the public of the results of the analysis when conclusion are able to be drawn.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

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