Safety Alerts & Recalls

What does this mean?
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.
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