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Dr. Bob is Robert Hsiung, MD,
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Posted by jrbecker76 on February 2, 2008, at 17:19:13
FDA Issues Health Advisory On Pfizer's Chantix Tablet
http://online.wsj.com/article/SB120189673998036071.html?mod=googlenews_wsj
By JENNIFER CORBETT DOOREN
February 1, 2008 3:35 p.m.
WALL STREET JOURNALWASHINGTON -- The Food and Drug Administration said it is "increasingly likely" that Pfizer Inc.'s smoking-cessation drug Chantix may be tied to serious psychiatric symptoms. The FDA's comment is part of a public health advisory issued Friday.
The public health advisory highlighted warnings issued by Pfizer last month stating that Chantix users should be monitored for suicidal behavior, depressed mood and other changes in behavior.
On Jan. 18, Pfizer said it would update the product label for Chantix to more prominently display post-marketing reports of adverse events that were first added to the product label last November after the FDA conducted a preliminary assessment of reported side effects.
Such reports included depression, changes in behavior and suicidal thinking in some patients within days or weeks after starting Chantix treatment. At the time, the FDA said the role of Chantix wasn't clear.
Now, the FDA said, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."
The FDA said it was working with Pfizer to develop a so-called medication guide highlighting the warnings for patients. A drug's label is typically directed at doctors.
"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products.
Chantix, an oral tablet taken up to twice daily for 12 weeks to help adults stop smoking, was approved in the U.S. in May 2006. Sales of the drug totaled $280 million during the fourth quarter, up from $68 million during the same time period in 2006.
Posted by clipper40 on February 3, 2008, at 9:46:37
In reply to FDA gives official warning for Chantix, posted by jrbecker76 on February 2, 2008, at 17:19:13
That's too bad because it has been helping some people but probably will be used a lot less now.
This is the end of the thread.
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