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FDA: Chantix May Pose Psychiatric Risks
Saturday February 2, 1:48 AM EST
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.
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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.
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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.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8ui15g80&date=20080202
This letting drug companies police themselves does not seem to be working out too well.
Saturday February 2, 1:48 AM EST
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.
~
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.
~
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.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8ui15g80&date=20080202
This letting drug companies police themselves does not seem to be working out too well.