Chantix, which is generically varenicline, was approved by the FDA in May last year and is a nicotine-free, oral tablet that is required to be taken twice daily. Outside of the United States the product is marketed as Champix.

The agency has said Pfizer has submitted reports on the anti-smoking drugs and a "case report citing erratic behavior in an individual who had used Chantix" has emerged. FDA has requested Pfizer to submit data on additional cases along similar lines. The FDA also said there was one death in a patient using Chantix to quit smoking.

"Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar," the agency added.

More than 4 million smokers in the United States are thought to have used the drug. Sales of Chantix for Pfizer totaled $241 million at the end of September.

Reacting to the FDA's early communication, Martina Flammer, Pfizer senior medical director said there was no "scientific evidence that establishes a causal relationship between Chantix and these reports." However the world's largest drug maker said it had changed Chantix's product label to reflect these early reports of depressed mood, agitation, changes in behavior, suicidal thoughts.

The FDA noted that all these effects are also observed following nicotine withdrawal and could not necessarily be laid at Chantix' door.

For now the FDA recommends healthcare professionals monitor patients taking Chantix for behavior and mood changes. Patients on Chantix, who experience mood swings may contact their doctor immediately.

"Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them," the FDA concluded.

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