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Popular Stop-Smoking Drugs to Carry Mental Health Risk Warnings 

Reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA's adverse event reporting system.

Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in buproprion users, the agency reported.

The FDA is not recommending discontinuation of the medications, which have been shown effective for quitting smoking, according to Dr. Curtis Rosebraugh, director of the agency's Office of Drug Evaluation II.

But the FDA is recommending that clinicians monitor their patients for neuropsychiatric symptoms after initiating treatment.

The FDA has been conducting a safety review of varenicline since receiving preliminary reports of problems in 2007.

Rosebraugh said it was somewhat surprising that a similar safety signal turned up for buproprion.

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