Smoking cessation drug needs stronger warning: FDA

WASHINGTON (Reuters) - U.S. regulators on Friday said the smoking cessation drug Chantix (Pfizer Inc.), known generically as varenicline, appears increasingly likely to be linked to serious psychiatric disturbance and called for stronger label warnings. The Food and Drug Administration said after an analysis of reports of suicidal thoughts and behavior potentially linked to the medication, it was calling for Pfizer to boost the prominence of current label warnings on the drug. "It appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms," the FDA's Public Health Advisory said. Chantix, approved in 2006, already carries a warning that some patients have experienced psychiatric symptoms, including depressed mood and suicide ideation, while on the drug. The FDA in November issued an "early communication" on the drug, saying it would analyze reports of suicidal thoughts and other unusual behavior. The FDA said the drug is effective but that patients should talk to their doctors about this new safety information. Patients should report to doctors any history of mental illness and be alert to changes in behavior. The drug has been prescribed to about 4 million people in the United States, according to Pfizer.