WASHINGTON (AP) — Pfizer says U.S. regulators have removed a bold-letter warning from its anti-smoking drug Chantix about the risks of dangerous psychiatric side effects.
The Food and Drug Administration action follows years of scrutiny into the smoking-cessation pill's risks, which received the agency's most stringent warning in 2009 after reports of suicidal tendencies, hostility and depression among some patients.
Friday's decision stems from an 8,000-patient study of smokers that found no elevated risk of psychiatric problems among Chantix users who had no prior history of mental illness. European regulators removed their own warning from the drug last year based on the same data.
Chantix's updated label will still mention reports of psychosis, paranoia, anxiety and other problems. But those events will not be highlighted in a so-called black box warning.