Chantix (Varenicline) - Risk of Certain Cardiovascular Adverse Events
Update: 6/16/11 - FDA notified healthcare professionals and patients that the Prescribing Information for Chantix will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
Read FDA alert
Chantix (Varenicline) - Reports of Suicidal Thoughts, Aggression and Erratic Behavior.
Pfizer, Inc., the manufacturer of Chantix, recently submitted to the FDA reports of cases where Chantix has been linked to suicidal thoughts and behavior. A preliminary assessment has shown that many of the cases have shown an increase in depression, suicidal thoughts and changes in emotion and behavior within days to weeks after beginning to take the medication.
The FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although there were other contributing factors, including alcohol use, the FDA has asked Pfizer to provide it with additional information from all cases in which the circumstances are similar to this case.
In addition to suicidal thoughts and aggression, Chantix has also caused severe drowsiness in patients, which affected their ability to drive or operate machinery.
The FDA has notified healthcare professionals to monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
If you or a loved one has suffered severe side effects after taking Chantix, call Cellino & Barnes now at 1-800-483-2050 or contact us online.