Safety Alerts & Recalls

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The FDA has notified healthcare professionals today about reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Varenicline to quit smoking. The role of Varenicline in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and can also aggravate underlying emotional problems. However, not all patients described in the cases had preexisting emotional problems and not all had discontinued smoking.

For more information, please visit:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm

FDA reviewing cases of suicidal ideation and occasional suicidal behavior

The FDA has notified healthcare professionals today about reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Varenicline to quit smoking. The role of Varenicline in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and can also aggravate underlying emotional problems. However, not all patients described in the cases had preexisting emotional problems and not all had discontinued smoking.

For more information, please visit: more information here

Source: FDA
Publication Date: 2007-11-20
Last Updated: 2009-12-06

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