FDA Reviewing Chantix

Scott Kappes

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The Food and Drug Administration is currently is the process of further review of the smoking cessation drug Chantix. This review comes in response to numerous complaints of erratic behavior and suicidal ideation from users of the drug. Pfizer, the manufacturer, was hoping that Chantix could become a blockbuster drug recognized as the common treatment for smoking cessation. By looking at sales one would assume they are well on the way to achieving this goal. However, it is not clear what affect this FDA investigation will have on the future of Chantix.

There is very little data available to the public as of thus far in the probe, but more information should be disclosed over the next several months. Chantix has already accounted for over $600 million dollars this year, with almost $250 million of that coming in the third quarter alone. Prescriptions have been on the rise since the drug was introduced just over a year ago.

The FDA investigation may create a scare for doctors and decrease the frequency at which some are prescribing the drug. The FDA says that role of Chantix in suicidal cases is still unclear, but does comment that quitting smoking can increase underlying psychiatric problems and create nicotine withdrawal symptoms that can be very debilitating for some.

James Kelly, analyst at Goldman Sachs, said: "It will be key to watch physician behavior in the wake of this public disclosure, as well as the FDA's future communications, based on additional data and analysis provided by Pfizer."

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