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New FDA Label Touts Chantix Safety; Pfizer Pushes to Remove Black Box

Sep 25, 2014

Ap News

The FDA updated the label of Pfizer's anti-smoking drug Chantix to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the drug.

Pfizer has now asked the FDA to completely remove the drug's black box warning -- the strictest FDA warning put on drug labels when there is reasonable evidence of serious side effects and risks -- which currently warns Chantix prescribers of links to hostility, agitation, depression and suicidal behavior.

According to Pfizer senior vice president, Steve Romano, "Based on all this new information, a boxed warning is not supported."

The FDA will convene a panel of outside experts on October 16 to review the latest data on Chantix's safety.

Read the AP News story