Alert issued on drug for helping smokers quit.(NEWS FROM THE FDS)

The Food and Drug Administration has issued an alert about postmarketing reports of suicidal thoughts, aggressive and erratic behavior, and drowsiness associated with varenicline, the smoking cessation drug marketed as Chantix.

A notice posted Nov. 20 on the agency's MedWatch site advises health care professionals to monitor patients taking varenicline for behavior and mood changes, and recommends that people taking the drug should contact their physicians if they experience mood or behavior changes, and should be cautious when driving or operating machinery, "until they know how quitting smoking with Chantix may affect them."

Varenicline, a nicotine receptor agonist, was approved by the FDA in 2006, and is taken orally. The notice points out that the review of the drug's safety is ongoing and that the agency is not advising health care providers to stop prescribing the drug.

The FDA is reviewing postmarketing reports of suicidal ideation and occasional suicidal behavior associated with varenicline, recently submitted by the drug's manufacturer, Pfizer Inc., as well as cases recently reported in the popular press and Internet sites, according to the notice.

A preliminary assessment of these reports indicates that many "reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating

Chantix treatment," according to the FDA. Because smoking cessation treatment with or without treatment is associated with nicotine withdrawal symptoms and exacerbation of underlying psychiatric illness, "the role of Chantix in these cases is not clear," although not all the patients in these reports have preexisting psychiatric illnesses and not all had stopped smoking.

The notice also refers to a highly publicized case of erratic behavior that resulted in the death of an individual who was taking varenicline to quit smoking. The FDA is reviewing material submitted by Pfizer in response to a request for information about similar cases. Alcohol and other factors appeared to have played a role in this case.

Reports of people who experienced drowsiness while taking the drug, and of impairment that affected the ability to drive or operate machinery, are also being reviewed by the FDA.

The FDA plans to issue another report when the safety review is completed and when more information or analyses become available.

In the varenicline label, suicidal ideation is listed as a "rare" treatment-emergent adverse effect associated with the drug in clinical trials, and aggression is listed as an "infrequent" adverse event.

More information is available at: www.fda.gov/medwatch/safety/2007/safety07, htm#Chantix. Adverse reactions to Chantix should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

BY ELIZABETH MECHCATIE

Senior Writer