Psychiatric Side Effects of Chantix to be Reviewed in Fall: FDA

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xhuffer

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Oct 21, 2011
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For real? It took FDA this long after their 2009 order? And now only need to wait until Fall?

"In 2009, the FDA ordered drug maker Pfizer to add a black box label -- the strongest safety warning -- to Chantix after it was linked to hostility, aggression, depression and suicidal thoughts. There were dozens of reports of suicide and suicidal behavior among people taking the drug."

Psychiatric Side Effects of Chantix to be Reviewed in Fall: FDA - Drugs.com MedNews
 

AgentAnia

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I've been under the impression that identifying and studying side effects of a drug was required and had to be reported before the FDA would approve it.

What's wrong with this picture?:

U.S. sales of Chantix began in 2006 and the FDA began investigating the drug's potential side effects in 2007.
 
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