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In November the U.S. Food and Drug Administration issued an Early Communication warning that Pfizer's anti-smoking drug Chantrix may be associated with increased suicidal thoughts and aggressive behavior.

On Friday the FDA issued a Public Health Advisory announcing that it has asked Pfizer to include the warning to the label of Chantrix.

The FDA stated that after reviewing adverse event reports that it appeared that it was increasingly likely that there may be "an association between Chantix and serious neuropsychiatric symptoms." The FDA has therefore asked Pfizer to increase the prominence of the label warning and in the prescribing section of the drug. The FDA also stated that it is working with Pfizer to finalize a Medication guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said  Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

The complete advisory is available on the U.S. Food and Drug Administration site.