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Drug may pose
psychiatric risks
(April 2008
Issue)
By Elinor Nelson
As if the challenge of quitting smoking hasn't been daunting enough,
it turns out that a promising new medication that's proving highly
effective may come with its own baggage. Chantix, which has been
prescribed to more than four million Americans since its approval
in May 2006, now comes with an Federal Drug Administration-ordered
warning about serious psychiatric side effects, including suicidal
behavior and ideation, depression, changes in behavior and agitation.
The FDA has issued an advisory about Chantix and cautions that
while most of these symptoms developed during Chantix treatment,
some developed following withdrawal from the drug. It warns that
the drug may cause worsening of a current psychiatric illness -
even if currently under control - or may cause a reoccurrence of
an old psychiatric illness. The FDA had received reports of 37 suicides
and more than 400 of suicidal behavior, and suggests that at least
some of the cases may be a result of the drug and not other causes.
Pfizer, the manufacturer, counters that the act of quitting smoking
can cause psychiatric problems on its own and denies that a direct
link has been proven. While psychiatric problems were not noted
in Chantix's clinical trials, they failed to include patients with
serious psychiatric illnesses in the studies.
So what is a practitioner to do? Nancy Rigotti, M.D., Harvard Medical
School professor and director of Massachusetts General Hospital's
Tobacco Research and Treatment Unit (and, she notes, consultant
to Pfizer) says it makes sense to be cautious about prescribing
Chantix and that followup is critical. The practitioner should
carefully monitor the patient, "calling and seeing how they're doing
symptom-wise within one week". This monitoring is especially important,
she states, when there is a history of depression. The problem,
Rigotti adds, is that increased depression can be a symptom of withdrawal
from smoking and smokers are more likely to have a history of depression.
Nevertheless, she points out that smoking undeniably causes lethal
diseases and Chantix is one of only three categories of drugs that
help with smoking cessation. "I think this is a little bit overblown
in the media," Rigotti says.
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