See link below for some “official” FDA information. On November 21, 2007 (TODAY) the FDA issued a MedWatch for Chantrix that contains the following:
"FDA is evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.
FDA recommends the following:
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them"
This is pretty much the stuff that would in a “black box” warning on the patient information.
The link to this info is:
http://www.medadnews.com/News/index.cfm?articleid=494286
BTW I googled 'Varenicline FDA" to find this info. Varenicline is the “generic” name for Chantrix.
peace,
c.
added a few minutes later. The “official” web side from Pfizer contains the full Prescribing Information (PI) for Chantrix. The PI includes the following in the section about side effects:
“PSYCHIATRIC DISORDERS. Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. Infrequent: Aggression, Agitation, Disorientation, Dissociation, Libido decreased, Mood swings, Thinking abnormal. Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation.”
This is pretty similar for ALL the “mood disorder meds”
For the full Prescribing information see: http://www.pfizer.com/files/products/uspi_chantix.pdf
I’m one of the strange creatures who always reads the entire Prescribing Information from the manufacturer. This is not easy to read, but contains ALL the side effects they found, even those that were very, very rare.
This gives you a whole more information than the sheet that comes with your prescribtions.
again, peace,
c.
P.S I think I’m done now!