CHANTIX Linked to Highest # Reports--Hostility-Aggression, Psychosis
- View SourceAlliance for Human Research Protection
A Catalyst for Debate
The latest January 2011 QuarterWatch (analyzing MedWatch adverse effect
reports for Quarter 2 of 2010) found that overall,the FDA received 33,068
domestic reports of serious injury, disability or death associated with drug
therapy in this quarter. This was an increase of 12% from the same quarter
one year ago and little changed from the revious quarter.
A year after FDA required a prominent boxed warning, a mandatory Medication
Guide for every patient and declining use, CHANTIX continued to account for
the largest numbers of reported serious psychiatric side effects that pose
serious risks of harm. The case reports involving CHANTIX, primarily of
hostility-aggression, depression and psychosis, pose serious risks--not only
to those who use it--but also to others who may be victimized by consumers
of the drug who become psychotic or aggressive.
For this reason, the Federal Aviation Administration has banned varenicline
for pilots and air traffic controllers; the Department of Transportation has
limited its use among truck drivers; and the Department of Defense has
banned it for use by some military personnel, including pilots and missile
"In the second quarter OF 2010, CHANTIX accounted for 130 possible cases
of clinical depression, 112 possible cases of hostility-aggression, and 70
cases of psychosis or losing touch with reality. "
So, why has the FDA failed to protect the public at large?
The time has come for the FDA use its regulatory authority to withdraw
CHANTIX from the market to protect the public at large--including children,
families, neighbors--from drug-induced violence.
Read more.... http://www.ahrp.org/cms/content/blogsection/0/9/
Contact: Vera Hassner Sharav
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