Weak Evidence for Removing Chantix Warning

October 15, 2014 11:12 PM

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Chantix has carried the black box warning since 2009 after reports of hostility, depression, and suicidal behavior among some patients taking the drug, the Associated Press reported. Drug maker Pfizer wants the black box warning removed, saying that recent studies and analyses indicate no increased risk of psychiatric problems between people taking Chantix and those using other smoking-cessation products.

However, FDA briefing documents posted online Tuesday said the evidence provided by Pfizer is low quality and there is little precedent for removing a black box warning from a prescription drug, the AP reported. An FDA panel of outside experts will consider the issue Thursday and make a recommendati...

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