Stop Smoking Aid Receives Approval in Japan

Scott Kappes

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Yesterday Pfizer announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare to manufacture and market the popular stop smoking aid known as Chantix in the US. The drug will be marketed as Champix in Japan, as it is in the UK and EU. This will be the first oral smoking cessation aid availible in Japan and Pfizer expects it to be very popular among Japanese smokers wishing to kick the habit. Some concern should accompany the approval as several health authorities have revised the labeling of their version of the drug to warn of a possible link between Chantix/Champix and neuropsychiatric events.

In both the US and the UK the drug has recently gained notoriety in the media after highly publicized stories link suggested the drug may be linked to possible thoughts of suicide and suicidal actions. In the US, thousands of adverse reactions flooded into the FDA's reporting system following the tragic shooting death of Dallas musician Carter Albrecht. He was shot and killed by a his girlfriend's neighbor after trying to kick down the door of their home at 4 am in an apparent psychotic episode. Those close to the musician say that a severe reaction to Chantix is the only thing that could explain the actions of the mild tempered Albrecht.

In the UK at least two suicides have been linked to the drug and thousands of adverse events have been reported to health authorities. In Australia, Champix hit the market at the turn of the new year and carried with it a warning of possible suicidal thought and action. The FDA also recently announced labeling changes for Chantix to inform consumers and physicians of the possible dangers associated with drug.

No causal relationship has been established as of thus far, but both the FDA and Pfizer have said that a link cannot be ruled out at this point. More studies are needed to determine the actual risks associated with drug. We will soon see how the Japanese market responds to Champix and any problems arise subsequent to its introduction to the Japanese market.