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Anti-Smoking Drug Linked to Suicide Risk

The connection between Chantix and serious psychiatric problems is "increasingly likely."
WASHINGTON (AP) - Government regulators said Friday the
connection between Pfizer's anti-smoking drug Chantix and serious
psychiatric problems is "increasingly likely."
      The Food and Drug Administration said it has received reports of
37 suicides and more than 400 of suicidal behavior in connection
with the drug. In November, the agency began investigating reports
of depression, agitation and suicidal behavior among patients
taking the popular twice-daily pill.
      The agency's announcement comes two weeks after Pfizer added
stronger warnings to the drug. In doing so, the company stressed
that a direct link between Chantix and the reported psychiatric
problems has not been established, but could not be ruled out.
      Pfizer suggested that since nicotine withdrawal alone can cause
mood swings and agitation, it may be impossible to determine if
Chantix aggravates those behaviors.
      But FDA said it found evidence of Chantix patients who
experienced psychiatric problems even though they were still
smoking.
      "There are a number of compelling cases that look like they are
the result of exposure to the drug itself and not other causes,"
said Bob Rappaport, a director at FDA's drug evaluation center.
Some patients experienced the same psychiatric problems after they
stopped using Chantix, he said, suggesting a negative reaction to
withdrawal.
      In a public advisory released Friday, FDA said patients taking
Chantix should tell their doctor about any history of mental
illness. Patients and family members should watch for any changes
in mood and behavior.
      "Chantix may cause worsening of current psychiatric illness
even if it is currently under control," reads the statement. "It
may also cause an old psychiatric illness to reoccur."
      FDA noted that patients with psychiatric problems were not
included in the original studies used to test Chantix's safety.
      Approved in May 2006, Chantix, already prescribed 4 million
times in the U.S., has been one of the few bright spots on Pfizer's
balance sheet. For full-year 2007, the drug had sales of $883
million, helping offset lower sales of older drugs, such as the
antidepressant Zoloft, which face generic competition.
      The tablets work by binding to nicotine receptors in the brain,
reducing the symptoms of withdrawal.
      GlaxoSmithKline makes Zyban, the only other non-nicotine,
anti-smoking drug for sale in the U.S. Part of the antidepressant
drug class, Zyban includes warnings about increased suicidal
behavior.
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