Chantix Warning Label: Does the FDA See Evidence for Removal?
(HealthDay News) — There is little evidence to support removing a black box warning about suicide risk from the prescription anti-smoking drug Chantix, the U.S. Food and Drug Administration says.
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 recommendation to the FDA. Last week, five public safety advocacy groups urged the FDA to expand the black box warning on Chantix to include information about blackouts, convulsions, and other problems reported in some patients.
Pfizer has paid about $300 million to settle more than 2,500 lawsuits alleging that Chantix caused psychiatric problems, injuries, and suicides, the AP reported.