Pfizer Inc. (NYSE:PFE) may garner approval to remove its “black box” warning from anti-smoking product Chantix.
The Food and Drug Administration (FDA) is considering eliminating the warning — which is the most severe one it issues — which suggests that Chantix may cause a series of adverse psychological side-effects, such as agitation and suicidal thoughts.
The move comes following a Pfizer study that compares the medication to other anti-smoking products and nicotine patches, and the research suggests that Chantix does not cause any more harm than other patches.
The FDA conducted its own research which revealed that Pfizer’s study is credible and perhaps Chantix should not have the black box label. 10 of 19 panelists for the agency recommended that the warning be removed, while four believe that the warning should be more severe, and five believe it should remain the same.
Chantix first received the black box warning in 2009. The company attempted to get it removed in an FDA hearing two years ago, but the agency declined Pfizer’s request.
There is a link between patients with psychiatric disorders becoming more prone to smoking, which suggests that the product does not necessarily exacerbate these symptoms as they could be related to previous conditions, or withdrawal from quitting tobacco products.
Despite the majority vote to remove the warning, the FDA still has the final word on whether or not the label is removed
PFE stock is up 0.8% Thursday.
