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U.S. health regulators on Friday allowed Pfizer Inc to remove a serious warning from the label of its smoking cessation treatment, Chantix, giving a new lease of life to the controversial drug that was approved a decade ago.

The U.S. Food and Drug Administration slapped a “black box” warning – the most severe available – on Chantix in 2009 after receiving thousands of reports linking the drug to mental health issues, including suicidal thoughts, hostility and agitation.

Pfizer, which has spent heavily on advertising for and settling lawsuits against Chantix, failed to get rid of the warning in 2014 after the FDA decided to wait for additional trial data.


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