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CHANTIX Linked to Highest # Reports--Hostility-Aggression, Psychosis

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  • veracare
    Alliance for Human Research Protection A Catalyst for Debate www.ahrp.org FYI The latest January 2011 QuarterWatch (analyzing MedWatch adverse effect reports
    Message 1 of 1 , Feb 1, 2011
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      Alliance for Human Research Protection
      A Catalyst for Debate
      www.ahrp.org

      FYI

      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.
      http://www.ismp.org/QuarterWatch/2010Q2.pdf

      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
      crews.

      QuarterWatch reports:
      "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
      veracare@...
      212-595-8974



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